Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1
NCT00577577, Phase 2, Completed, Insmed Incorporated; results first posted 2022-01-06
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1 | ClinicalTrials.gov |
| NCT number | NCT00577577 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 69 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Insmed Incorporated | ClinicalTrials.gov |
| Conditions | Myotonic Dystrophy Type 1 | ClinicalTrials.gov |
| Interventions | rhIGF-I/rhIGFBP-3, placebo | ClinicalTrials.gov |
| First posted | 2007-12-20 | ClinicalTrials.gov |
| Last updated | 2022-01-06 | ClinicalTrials.gov |
| Results first posted | 2022-01-06 | ClinicalTrials.gov |
Registered outcomes 32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance | Baseline and Week 24 | The 6MWT measured the distance in meters that participants were able to walk over a total of six minutes. After a 10 minute resting period, the participants completed the 6MWT on a hard, flat surface at baseline and at Week 24. | ClinicalTrials.gov |
| Primary | Change From Baseline in Daily Step Count | Baseline and Week 24 | The number of steps taken per day was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a negative change from baseline indicates a decrease in the number of daily steps. | ClinicalTrials.gov |
| Primary | Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking | Baseline and Week 24 | The peak activity index measures the number of steps walked in the 30 minutes of fastest walking that occurred in a 24 hour period. This was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of steps walked during the 30 minute period of fastest walking. | ClinicalTrials.gov |
| Primary | Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity | Baseline and Week 24 | The sustained activity index measures the highest number of steps sustained over a continuous 20 minute period. This was measured using a step activity monitor for 7 days at baseline and again at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of steps walked over 20 minutes of activity. | ClinicalTrials.gov |
| Primary | Change From Baseline in the Percentage of Time That Participants Spent Inactive | Baseline and Week 24 | Change from baseline scores were measured where a negative change from baseline indicates less time spent inactive. | ClinicalTrials.gov |
| Primary | Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | Baseline and Week 24 | Participants were timed on their ability to climb up 4 stairs and timed separately to climb down 4 stairs at baseline and at week 24. The stairs were free-standing or the same flight of stairs was used at each assessment. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the time taken for paticipants to ascend or descend 4 stairs. | ClinicalTrials.gov |
| Primary | Change From Baseline in Time Taken to Traverse 30 Feet | Baseline and Week 24 | Participants were timed on their ability to travel 30 feet on the same surface at each assessment at baseline and at Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the time taken to travel 30 feet. | ClinicalTrials.gov |
| Primary | Change From Baseline in Purdue Pegboard Test Scores | Baseline and Week 24 | The Purdue Pegboard Test consists of a board with two sets of 25 holes, 4 concave cups, and a number of small metal pins. Participants were required to pick up the pins from a holder and place them in the holes as quickly as possible over 30 seconds with their dominant hand. The score was calculated as the number of pins placed into holes in 30 seconds and was measured at baseline and Week 24. Change from baseline scores were measured where a positive change from baseline indicates an improvement in the number of pins placed in the board. | ClinicalTrials.gov |
| Primary | Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down | Baseline and Week 24 | FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. | ClinicalTrials.gov |
| Primary | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted While Sitting or Lying Down | Baseline and Week 24 | FVC is the volume of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. | ClinicalTrials.gov |
| Primary | Change From Baseline in Manual Muscle Test (MMT) Scores | Baseline and Week 24 | The MMT was used to assess muscle strength in the distal muscles and the proximal muscles. Distal muscles assessments included wrist extension, wrist flexion, ankle dorsiflexion and plantarflexion. Proximal muscle assessments included shoulder abduction, elbow extension, elbow flexion, hip extension, hip abduction, hip flexion, knee extension and knee flexion. In MMT, each muscle assessment was given a score of 0 to 5, where 0 indicated 'no contraction palpable' and 5 indicated 'normal strength'. The scores from each muscle were summed and the maximum overall score of all measured muscles was 140, the maximum distal score was 40 and the maximum proximal score was 80. Higher scores indicated higher muscle strength. Change from baseline scores were measured where a positive change from baseline indicates an improvement in muscle strength. | ClinicalTrials.gov |
| Primary | Change From Baseline in Selective Reminding Test T-Scores (Total Word and Delayed Words) | Baseline and Week 24 | The Selective Reminding Test measures verbal learning and memory and involves remembering a verbal list of 12 words. Participants were required to recall the 12 words presented. Words that were missed on recall were presented again, and the process was repeated until all 12 words were correctly recalled. The total word list recall and delayed recall were calculated as T-scores. Raw scores were converted to T-score using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance. | ClinicalTrials.gov |
| Primary | Change From Baseline in Selective Reminding Test Raw Scores (Cued Recall and Recognition) | Baseline and Week 24 | The Selective Reminding Test measures verbal learning and memory and involves remembering a verbal list of 12 words. Participants were required to recall the 12 words presented. Words that were missed on recall were presented again, and the process is repeated until all 12 words were correctly recalled. The cued recall scores ranged from 0-11 and multiple choice recognition scores ranged from 0-12. Change from baseline scores were measured where a positive change from baseline indicates an improvement in verbal recall and memory. | ClinicalTrials.gov |
| Primary | Change From Baseline in Rey Complex Figure (RCF) Test Scores | Baseline and Week 24 | The Rey Complex Figure Test (RCFT) assesses visuospatial construction ability and visual memory through four different tests: copy (copying a complex geometric figure), immediate recall of the figure (drawing figure from memory at 3 minutes), delayed recall (drawing figure at 30 minutes after initial copy), and recognition score (selecting individual parts of the figure from sketches provided). Copy performances are divided into 18 components with a maximum score of 2 each. The maximum score for each figure is 36. | ClinicalTrials.gov |
| Primary | Change From Baseline in Letter-Number Sequencing (LNS) Test Scores | Baseline and Week 24 | The LNS test from the Welchsler Adult Intelligence Scale-III was used to assess working memory. The test required that participants recall, in order, numbers and letters presented in an unordered sequence. The number of items is 21. With each item being marked 0 if reported incorrectly or 1 if reported correctly, the maximum score is 21. Raw scores were converted into T-scores using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance. | ClinicalTrials.gov |
| Primary | Change From Baseline in Trail Making Test (TMT) Scores | Baseline and Week 24 | The TMT assesses executive function, sequencing, mental flexibility, visual spanning speed and motor function. In TMT Part A, the participant had to draw lines in the correct order between 25 numbers randomly arranged on the page. In TMT Part B, the participant had to draw lines between 25 numbers and letters in alternating order (e.g., 1-A-2-B...etc). Times for Part A and Part B were used to derive T-scores which can range from a minimum of 0 and a maximum of 100. Raw scores were converted into T-scores using available normative data. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance. | ClinicalTrials.gov |
| Primary | Change From Baseline in the Stroop Color Word Test Scores | Baseline and Week 24 | The Stroop Color Word Test measures selective attention and cognitive flexibility. The test has three parts, the Word test (reading words), the Color test (naming the ink color in which words are displayed) and the Color-Word test (saying the ink color not reading the word). An interference score was calculated from the Color, Word and Color-Word scores and is an indication of how well a person can complete a task while disregarding interfering information. Raw scores were converted into T-scores using available normative data. Scores range from 0 to 100. Change from baseline T-scores were measured where a positive change from baseline indicates improvement in performance. | ClinicalTrials.gov |
| Primary | Change From Baseline to Week 24 Scores on the Beck Depression Inventory II (BDI-II) Questionnaire | Baseline and Week 24 | BDI-II is a validated self-reported instrument of 21 questions which are each scored 0-3. Total scores range from 0-63, with higher score totals indicating more severe depression symptoms. {0-9: indicates minimal depression; 0-18: indicates mild depression; 19-29: indicates moderate depression; 30-63: indicates severe depression. Lower scores indicate no or minimal depression, with a maximum total score of 63. | ClinicalTrials.gov |
| Primary | Change From Baseline in Average Fasting Glucose Concentration in the Blood | Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution | Participants were administered 75 grams (g) glucose solution prior to administration of the first dose of IPlex™ and after administration of the last dose. A 2-hour oral glucose tolerance test (OGTT) was performed under fasted conditions. | ClinicalTrials.gov |
| Primary | Change From Baseline in Average Fasting Insulin Concentration in the Blood | Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution | Participants were administered 75 g glucose solution prior to administration of the first dose of IPLEX™ and after administration of the last dose. A 2-hour OGTT was performed under fasted conditions. | ClinicalTrials.gov |
Outcomes 32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | meters | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Daily Step Count | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | daily step count | MEAN | ClinicalTrials.gov |
| PRIMARY | Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | steps per minute (steps/min) | MEAN | ClinicalTrials.gov |
| PRIMARY | Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | steps per minute (steps/min) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in the Percentage of Time That Participants Spent Inactive | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | percentage of time | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Time Taken to Traverse 30 Feet | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | seconds | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Purdue Pegboard Test Scores | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | number of pins | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | litres | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted While Sitting or Lying Down | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | Percentage (%) of FVC predicted | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Manual Muscle Test (MMT) Scores | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | Score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Selective Reminding Test T-Scores (Total Word and Delayed Words) | Baseline and Week 24 | Modified Per Protocol Population: | T-score | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Selective Reminding Test Raw Scores (Cued Recall and Recognition) | Baseline and Week 24 | Modified Per Protocol Population | Score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Rey Complex Figure (RCF) Test Scores | Baseline and Week 24 | Modified Per Protocol Population | Score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Letter-Number Sequencing (LNS) Test Scores | Baseline and Week 24 | Intention to treat (ITT) population: all enrolled participants who had at least one dose of IPLEX™ or placebo and had at least one post-baseline efficacy assessment. Only participants with data available for analysis are reported. | Score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Trail Making Test (TMT) Scores | Baseline and Week 24 | Modified Per Protocol Population | T-score | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in the Stroop Color Word Test Scores | Baseline and Week 24 | Modified Per Protocol Population | T-score | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline to Week 24 Scores on the Beck Depression Inventory II (BDI-II) Questionnaire | Baseline and Week 24 | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | Score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Average Fasting Glucose Concentration in the Blood | Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | milligrams per deciliter (mg/dL) | MEAN | ClinicalTrials.gov |
| PRIMARY | Change From Baseline in Average Fasting Insulin Concentration in the Blood | Baseline - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution; Week 24 - Pre-dose and 30, 60, 90 and 120 minutes post glucose solution | Per protocol (PP) population: all enrolled participants who were at least 80% compliant with study dosing, had no more than 21 days interruption in therapy at any one time, had efficacy assessments required at the Week 24 study visit, met all inclusion and exclusion criteria, and were not major protocol violators. Only participants with data available for analysis are reported. | micro units per milliliter (μU/mL) | MEDIAN | ClinicalTrials.gov |
Results by group 94
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance | IPLEX™ | 12.40 | Standard Deviation 44.75 | meters | ClinicalTrials.gov | |
| Change From Baseline to Week 24 in Distance Walked as Assessed by the Six-minute Walk Test (6MWT) Distance | Placebo | 20.11 | Standard Deviation 50.87 | meters | ClinicalTrials.gov | |
| Change From Baseline in Daily Step Count | IPLEX™ | -140 | Standard Deviation 1222 | daily step count | ClinicalTrials.gov | |
| Change From Baseline in Daily Step Count | Placebo | -58 | Standard Deviation 1209 | daily step count | ClinicalTrials.gov | |
| Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking | IPLEX™ | 0.5 | Standard Deviation 6.9 | steps per minute (steps/min) | ClinicalTrials.gov | |
| Peak Activity Index: Change From Baseline in Number of Steps Walked Per Minute During the 30 Minute Period of Fastest Walking | Placebo | 1.1 | Standard Deviation 6.0 | steps per minute (steps/min) | ClinicalTrials.gov | |
| Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity | IPLEX™ | -0.9 | Standard Deviation 8.3 | steps per minute (steps/min) | ClinicalTrials.gov | |
| Sustained Activity Index: Change From Baseline in the Highest Number of Steps Walked Per Minute Over 20 Minutes of Activity | Placebo | 0.8 | Standard Deviation 5.9 | steps per minute (steps/min) | ClinicalTrials.gov | |
| Change From Baseline in the Percentage of Time That Participants Spent Inactive | IPLEX™ | -0.4 | Standard Deviation 6.6 | percentage of time | ClinicalTrials.gov | |
| Change From Baseline in the Percentage of Time That Participants Spent Inactive | Placebo | -0.0 | Standard Deviation 5.2 | percentage of time | ClinicalTrials.gov | |
| Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | IPLEX™ | Ascend 4 stairs | 0.0 | Standard Deviation 0.8 | seconds | ClinicalTrials.gov |
| Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | Placebo | Ascend 4 stairs | -0.5 | Standard Deviation 1.2 | seconds | ClinicalTrials.gov |
| Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | IPLEX™ | Descend 4 stairs | -0.1 | Standard Deviation 1.0 | seconds | ClinicalTrials.gov |
| Change From Baseline in Time Taken for Participants to Ascend and Descend 4 Stairs | Placebo | Descend 4 stairs | -0.5 | Standard Deviation 1.5 | seconds | ClinicalTrials.gov |
| Change From Baseline in Time Taken to Traverse 30 Feet | IPLEX™ | 0.2 | Standard Deviation 1.3 | seconds | ClinicalTrials.gov | |
| Change From Baseline in Time Taken to Traverse 30 Feet | Placebo | -0.2 | Standard Deviation 2.2 | seconds | ClinicalTrials.gov | |
| Change From Baseline in Purdue Pegboard Test Scores | IPLEX™ | -0.2 | Standard Deviation 2.4 | number of pins | ClinicalTrials.gov | |
| Change From Baseline in Purdue Pegboard Test Scores | Placebo | 0.3 | Standard Deviation 1.5 | number of pins | ClinicalTrials.gov | |
| Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down | IPLEX™ | Sitting FVC | -0.1 | Standard Deviation 0.3 | litres | ClinicalTrials.gov |
| Change From Baseline in Forced Vital Capacity (FVC) Volume While Sitting or Lying Down | Placebo | Sitting FVC | 0.0 | Standard Deviation 0.5 | litres | ClinicalTrials.gov |
Participant flow 8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | IPLEX™ | 34 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 35 | ClinicalTrials.gov | |
| Overall Study | Received Treatment | IPLEX™ | 34 | ClinicalTrials.gov | |
| Overall Study | Received Treatment | Placebo | 35 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | IPLEX™ | 29 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 30 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | IPLEX™ | 5 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 5 | ClinicalTrials.gov |
Adverse events 362
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Ear Pain | Ear and labyrinth disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Ear Pain | Ear and labyrinth disorders | Placebo | 0 | 35 | ClinicalTrials.gov | |
| other | Vision Blurred | Eye disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Vision Blurred | Eye disorders | Placebo | 2 | 35 | ClinicalTrials.gov | |
| other | Abdominal Pain | Gastrointestinal disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 2 | 35 | ClinicalTrials.gov | |
| other | Consitpation | Gastrointestinal disorders | IPLEX™ | 8 | 34 | ClinicalTrials.gov | |
| other | Consitpation | Gastrointestinal disorders | Placebo | 2 | 35 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | IPLEX™ | 6 | 34 | ClinicalTrials.gov | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 35 | ClinicalTrials.gov | |
| other | Gastroesophageal Reflux Disease | Gastrointestinal disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Gastroesophageal Reflux Disease | Gastrointestinal disorders | Placebo | 0 | 35 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | IPLEX™ | 4 | 34 | ClinicalTrials.gov | |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 35 | ClinicalTrials.gov | |
| other | Stomach Discomfort | Gastrointestinal disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Stomach Discomfort | Gastrointestinal disorders | Placebo | 1 | 35 | ClinicalTrials.gov | |
| other | Vomiting | Gastrointestinal disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 35 | ClinicalTrials.gov | |
| other | Asthenia | General disorders | IPLEX™ | 2 | 34 | ClinicalTrials.gov | |
| other | Asthenia | General disorders | Placebo | 1 | 35 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | IPLEX™ | 1 | 34 | ClinicalTrials.gov |
| Total, all-cause mortality | Placebo | 0 | 35 | ClinicalTrials.gov |
| Total, other adverse events | IPLEX™ | 31 | 34 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 34 | 35 | ClinicalTrials.gov |
| Total, serious adverse events | IPLEX™ | 7 | 34 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 6 | 35 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IPLEX™ vs Placebo: deaths from any cause | Trial comparisons |
| IPLEX™ vs Placebo: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Letter-Number Sequencing Task | Primary outcome | ConductCognition |
| Selective Reminding Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)