Trial · NCT02175004
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Related to Study Drug | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | An adverse event (AE) is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is an important medical event. TEAEs considered related to the study drug as assessed by the Investigator are reported. |
| Primary | Percentage of Participants With Change From Baseline in Vital Signs | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | Vital signs included blood pressure, heart rate, respiratory rate, and temperature. Only categories with at least one participant with event are reported. |
| Primary | Percentage of Participants With Change From Baseline in Weight | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | As prespecified in the protocol, percentage of participants with change from baseline in weight is reported in 2 categories, decrease of ≥7% from Baseline and increase of ≥7% from Baseline. |
| Primary | Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Test Values | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | Clinical laboratory tests included the analysis of chemistry, haematology, and urinalysis. Any value outside the normal range will be flagged for the attention of the investigator who will assess whether or not a flagged value is of clinical significance. Only those categories with at least one participant with event are reported. Normal range of creatinine clearance is 110 to 150 mL/min in males and 100 to 130 mL/min in females. Normal urine protein to creatinine (P/C) ratio= \<0.2. Normal range for Alanine Aminotransferase (ALT) is 4 to 36 units per liter (U/L). Platelets normal range=140×10\^9/L to 400×10\^9/L. |
| Primary | Percentage of Participants With Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) as Determined by Electrocardiogram (ECG) | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | Normal QTcF at Baseline is defined as ≤450 milliseconds (ms) for males or ≤470 ms for females. Percentage of participants with QT interval outside of normal range are reported. |
| Primary | Percentage of Participants Using Concomitant Medication for Nervous and Cardiovascular System Disorders | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | A concomitant therapy was any non-protocol-specified drug or substance (including over-the counter medications, herbal medications, and vitamin supplements) administered between signing of informed consent and the final post-treatment visit for treating nervous and cardiovascular system disorders. |
| Primary | Percentage of Participants With Change From Baseline in Ophthalmic Examination as Assessed by Visual Acuity Changes | From first dose of study drug up to 3 months post treatment period of 260 weeks (Up to approximately 272 weeks) | |
| Primary | Percentage of Participants With Change From Baseline in Light Detection Ability Measured by Electroretinography | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | |
| Secondary | Change From Baseline in the Modified Neuropathy Impairment Score (mNIS)+7 Composite Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | The mNIS+7 composite score is a measure of neurologic impairment that evaluates muscle weakness, sensation, reflexes, nerve conduction, and autonomic function. The mNIS+7 Composite Score has a range of -22.32 to 346.32 and a higher mNIS+7 composite score indicates worsening disease. A positive change from Baseline indicates worsening of polyneuropathy impairments. Mixed Effects Model with Repeated Measures (MMRM) was used for the analysis. |
| Secondary | Change From Baseline in the mNIS +7 Component: Heart Rate to Deep Breathing Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | Heart rate to deep breathing is a quantitative autonomic test using the CASE IV instrument that measures a participant's change in heart rate after deep breathing. The score of this component ranges from 0 to 3.72 points. Higher scores indicate impairment. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the mNIS +7 Component: Nerve Conduction Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | The nerve conduction tests are quantitative tests that measure the conduction attributes of preselected nerves. The score range of this component is 0 to 18.6 points. Higher scores indicate impairment. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the mNIS +7 Component: Heat-Pain Sensory Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | The Heat-Pain Sensory test uses the CASE IV instrument to perform standardized psychophysical measurement to determine pain sensory thresholds in response to heat. The maximum score of this component is 0 to 40 points. Higher scores indicate impairment. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the mNIS +7 Component: Touch-Pressure Sensory Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 | The Touch-Pressure Sensory test uses the CASE IV instrument to perform standardized psychophysical measurement to determine pressure sensory thresholds in response to touch. The score range of this component is 0 to 40 points. Higher scores indicate impairment. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the Neuropathy Impairment (NIS) Composite Score at Week 52 of Years 4 and 5 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Week 52 of Years 4 and 5 | The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244 and a higher NIS score indicates lower function. A positive change from Baseline indicates worsening. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the NIS Component: Cranial Nerves Score at Week 52 of Years 4 and 5 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Week 52 of Years 4 and 5 | Cranial Nerve assessment involves testing 3rd and 6th nerves and facial, palate, and tongue weakness. The score range for this component is 0 to 40 points. Higher scores indicate worsening. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the NIS Component: Muscle Weakness Score at Week 52 of Years 4 and 5 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Week 52 of Years 4 and 5 | Muscle weakness involves testing 19 movements of muscles. The score range of this component is 0 to 152 points. Higher scores indicate worsening. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the NIS Component: Reflexes Score at Week 52 of Years 4 and 5 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Week 52 of Years 4 and 5 | The Reflexes Score involves testing 5 reflexes to stimuli. The score range of this component is 0 to 20 points. Higher scores indicate worsening. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the NIS Component: Sensory Score at Week 52 of Years 4 and 5 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Week 52 of Years 4 and 5 | The Sensory Score is based on testing an index finger and a big toe each to 4 stimuli. The score of this component ranges from 0 to 32 points. Higher scores indicate impairment. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) Questionnaire Total Score at Weeks 78 and 156 | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 and at the end of each subsequent treatment year (Week 52 of Years 4 and 5) | The Norfolk QoL-DN score is a measure of physical function/large fiber neuropathy, symptoms, activities of daily living, small fiber neuropathy, and autonomic neuropathy. The Norfolk QoL-DN total score has a range of -4 to 136, and a higher Norfolk QoL-DN score indicates poorer QoL. A positive change from Baseline indicates worsening in the QoL. MMRM was used for the analysis. |
| Secondary | Change From Baseline in the Norfolk QoL-DN Physical Functioning/Large Fiber Neuropathy Domain Score | Baseline (Baseline is the Baseline of the Previous Study- Study CS2), Weeks 78 and 156 and at the Week 52 of Year 4 | The Norfolk QoL-DN physical functioning/large fiber neuropathy domain score is a sub-score of the total Norfolk QoL-DN Questionnaire. The Norfolk QoL-DN physical function/large fiber neuropathy domain score has a range of -4 to 56, and a higher Norfolk QoL-DN domain score indicates poorer quality of life (QoL). A positive change from Baseline indicates worsening in the QoL. MMRM was used for the analysis. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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