Trial · NCT03452488
A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
NCT03452488, Phase 2, Completed, Biophytis; results first posted 2024-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT). Trials, record NCT03452488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03452488
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double-blind, Placebo-controlled, Randomized INTerventional Clinical Trial (SARA-INT)
- NCT number
- NCT03452488
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 233 participants, actual
- Lead sponsor
- Biophytis
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Interventions
- BIO101, Placebo
- First posted
- 2018-03-02
- Last updated
- 2024-10-01
- Results first posted
- 2024-10-01
- Limitations and caveats
Due to the coronavirus disease 2019 (COVID-19) outbreak, the implementation of the clinical protocol was affected, including but not limited to the scheduled site visit for safety and/or efficacy, site visits for monitoring, investigational product delivery, collection of adverse events (AEs) and concomitant medications. This led to \>50% loss of efficacy data for the primary endpoint and other performance assessments.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Baseline and 6 Months | Gait speed was measured using the 400 MW test, which measured how long it took the participant to walk a distance of 400 meters. Missing data imputed using adjusted Bayesian Multiple Imputation (MI) methods for Non-Completers who failed to perform the Test feasibility and Multiple Imputation for participants who without data on on-Site visit. Data up to 9 months was used where 6 months data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Short Form-36 (SF-36) 10 Item Physical Function Domain (PF-10) Sub-score | Baseline and 6 Months | The Physical Function Domain (PF-10) of the SF-36 assesses an individual's perceived physical functioning and limitations in various activities. It consists of ten items that ask about a person's ability to perform different physical activities and tasks. Scores on the PF-10 range from 0 to 100 where 100 indicates no physical limitations. Missing data imputed using adjusted Bayesian MI methods. Data up to 9 month was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Handgrip Strength Test | Baseline and 6 Months | Handgrip strength was a commonly used measure of upper body skeletal muscle function and had been widely used as a general indicator of frailty with predictive validity for both mortality and functional limitations. Participants were instructed to stand upright and with the dynamometer beside them but not against their body. Strength was measured three times for both hands. The highest value of all 3 attempts was kept for further analysis. Grip strength was measured in the dominant hand using a hydraulic grip strength dynamometer. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Appendicular Lean Body Mass (ALM) Based on Dual-energy X-ray Absorptiometry (DEXA) Measurements | Baseline and 6 Months | DEXA scans provided accurate measurements of body composition, recording fat and lean mass distribution throughout the entire body. Foundation of National Health Institute (FNIH) project report recommended ALM alone was used to measure gender-specific low muscle mass. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Rate of Response for Completing 400 MW Test After 6 Months | Baseline and 6 Months | A responder was defined as an improvement (increase) of 0.1 m/s or more in 400MW gait speed test compared to baseline. A non-responder was defined as a participant that was not a responder. Participants with a missing value at the visit and/or missing baseline value were considered as non-responders. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Muscle Strength Based on Knee Extension | Baseline and 6 Months | Isometric knee extension torque was measured with a knee extension dynamometer chair. The participants were positioned in an upright position, with straps to affix the hips to the chair and the ankle to a force or torque transducer at the knee angle of 90°. Lever arm length was recorded as the distance between the knee axis of rotation and the middle of the pad. Knee extension was measured using the maximum peak torque measurement Newton meter (Nm) for 60°/s, 90°/s and 180°/s for the tested leg (either right or left). The Knee extension torque was obtained either directly or by multiplying recorded peak force with the lever arm length. The assay with the highest torque output was taken for analyses. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Time for Five Chair Stands as Part of the Short Physical Performance Battery (SPPB) Assessment | Baseline and 6 Months | The SPPB was a series of tests designed to examine physical movements. The chair stands tests involved standing from a chair a number of times to test leg strength. Each performance measures were assigned a score ranging from 0 to 4, with 4 indicating the highest level of performance and 0 the inability to complete the test. The time to complete the task was recorded. The time required to perform five chair stands was scored as follows: ≥ 16.70 sec = 1; 13.70 to 16.69 sec = 2; 11.20 to 13.69 sec = 3; ≤ 11.19 = 4. A score of 0 was assigned to participants unable to perform the task. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding sub scores from the chair stands test. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Distance in the 6-Minute Walk Test (6MWT) | Baseline and 6 Months | The 6MWT was a test for functional exercise capacity and involved measuring the distance a participant could cover within the allotted time of 6 minutes. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in Pepper Assessment Tool for Disability (PAT-D) for Obese Participants | Baseline and 6 Months | The PAT-D was a disability questionnaire which asked respondents how much difficulty they had with a range of activities with functioning. PAT-D scores range from 1 (worst) to 5 (best). Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
| Secondary | Change From Baseline to 6 Months in SPPB Total Score | Baseline and 6 Months | The SPPB was a series of tests designed to examine physical movements. Results of the SPPB included total gait speed score, total balance test score, and total chair stand score. The first tests examined balance (without the assistance of a cane or walker) with the feet in three different orientations, the second test examined gait speed, and the third tests involved standing from a Chair a number of times to test leg strength. A score of 0 was assigned to participants unable to perform the task. A summary score ranging from 0 (worst performers) to 12 (best performers) was calculated by adding sub scores from the walking speed, chair stands and balance tests. Data up to month 9 was used where 6 month data were unavailable for participants enrolled during the COVID-19 pandemic. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Baseline and 6 Months | Full Analysis Set: The Full Analysis Set (FAS) population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included.~One participant randomized but not treated with 175 mg BIO101. | Meter/Second (m/s) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Short Form-36 (SF-36) 10 Item Physical Function Domain (PF-10) Sub-score | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Handgrip Strength Test | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | kilograms (Kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Appendicular Lean Body Mass (ALM) Based on Dual-energy X-ray Absorptiometry (DEXA) Measurements | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Kg | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Response for Completing 400 MW Test After 6 Months | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with rate of response for completing 400 MW test were included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to 6 Months in Muscle Strength Based on Knee Extension | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. This data represents Knee Extension of Highest Reading from all Degrees. Participants with data available were included. | Newton meter (Nm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Time for Five Chair Stands as Part of the Short Physical Performance Battery (SPPB) Assessment | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Distance in the 6-Minute Walk Test (6MWT) | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | Meters | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in Pepper Assessment Tool for Disability (PAT-D) for Obese Participants | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 6 Months in SPPB Total Score | Baseline and 6 Months | Full Analysis Set: Population consists of randomized participants, excluding participants who failed to take at least one dose of trial medication and had a very early withdrawal (first week after randomization) definitely not related to study medication and lacked any post randomization data. Participants with data available were included. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Placebo | Gait Speed based on Mixed Effect Model | 0.0093 | 95% Confidence Interval -0.0369 to 0.0556 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 175mg BIO101 | Gait Speed based on Mixed Effect Model | 0.0457 | 95% Confidence Interval -0.0014 to 0.0927 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 350mg BIO101 | Gait Speed based on Mixed Effect Model | 0.0478 | 95% Confidence Interval 0.0050 to 0.0907 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Placebo | Gait Speed Based on Adjusted Bayesian Imputation | -0.2886 | 95% Confidence Interval -0.3641 to -0.2132 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 175mg BIO101 | Gait Speed Based on Adjusted Bayesian Imputation | -0.2543 | 95% Confidence Interval -0.3347 to -0.1738 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 350mg BIO101 | Gait Speed Based on Adjusted Bayesian Imputation | -0.2014 | 95% Confidence Interval -0.2790 to -0.1238 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | Placebo | MI + Adjusted Bayesian Imputation | -0.0188 | 95% Confidence Interval -0.0743 to 0.0366 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 175mg BIO101 | MI + Adjusted Bayesian Imputation | -0.0066 | 95% Confidence Interval -0.0547 to 0.0415 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Gait Speed for 400 Meter Walking (MW) Test | 350mg BIO101 | MI + Adjusted Bayesian Imputation | 0.0500 | 95% Confidence Interval -0.0013 to 0.1013 | Meter/Second (m/s) |
| Change From Baseline to 6 Months in Short Form-36 (SF-36) 10 Item Physical Function Domain (PF-10) Sub-score | Placebo | Analysis based on Mixed Effect Model for MMRM | 7.3 | 95% Confidence Interval 2.4 to 12.3 | score on a scale |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 81 | |
| Overall Study | STARTED | 175mg BIO101 | 76 | |
| Overall Study | STARTED | 350mg BIO101 | 76 | |
| Overall Study | COMPLETED | Placebo | 70 | |
| Overall Study | COMPLETED | 175mg BIO101 | 64 | |
| Overall Study | COMPLETED | 350mg BIO101 | 69 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | 175mg BIO101 | 12 | |
| Overall Study | NOT COMPLETED | 350mg BIO101 | 7 |
Source ClinicalTrials.gov
Adverse events738
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 |
|---|---|---|---|---|---|---|
| other | AV block third degree | Cardiac disorders | Placebo | 1 | 81 | 1 |
| other | AV block third degree | Cardiac disorders | 175mg BIO101 | 0 | 75 | 0 |
| other | AV block third degree | Cardiac disorders | 350mg BIO101 | 0 | 74 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | Placebo | 1 | 81 | 1 |
| other | Acute myocardial infarction | Cardiac disorders | 175mg BIO101 | 0 | 75 | 0 |
| other | Acute myocardial infarction | Cardiac disorders | 350mg BIO101 | 0 | 74 | 0 |
| other | Age indeterminate inferior myocardial infarction | Cardiac disorders | Placebo | 1 | 81 | 1 |
| other | Age indeterminate inferior myocardial infarction | Cardiac disorders | 175mg BIO101 | 0 | 75 | 0 |
| other | Age indeterminate inferior myocardial infarction | Cardiac disorders | 350mg BIO101 | 0 | 74 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 81 | 1 |
1 to 10 of 738Source ClinicalTrials.gov
See all 738 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 81 |
| Total, all-cause mortality | 175mg BIO101 | 0 | 75 |
| Total, all-cause mortality | 350mg BIO101 | 1 | 74 |
| Total, other adverse events | Placebo | 48 | 81 |
| Total, other adverse events | 175mg BIO101 | 45 | 75 |
| Total, other adverse events | 350mg BIO101 | 38 | 74 |
| Total, serious adverse events | Placebo | 10 | 81 |
| Total, serious adverse events | 175mg BIO101 | 10 | 75 |
| Total, serious adverse events | 350mg BIO101 | 4 | 74 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03452488
GET https://conductscience.org/api/trials/v1/NCT03452488/results?page=2