Trial · NCT03214588
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Inverse Time to Complete the 9-Hole Peg Test (9-HPT-1) | Baseline and Week 12 | Full analysis set (FAS) included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | 1/seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Activities of Daily Living (ADL) Component Score of the Friedreich Ataxia Rating Scale (FARS) | Baseline and Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Inverse Time to Complete the 9-HPT-1 | Baseline and Weeks 2 and 7 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | 1/seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the ADL Component Individual Item Scores | Baseline and Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Modified Friedreich Ataxia Rating Scale Neurological Examination (mFARS-neuro) Total Score | Baseline and Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the mFARS-neuro Subscales Scores | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the mFARS-neuro Individual Item Scores | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Timed 25-Foot Walk (T25FW) | Baseline and Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | seconds | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 9-HPT and T25FW Composite Score | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | z-score | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low-Contrast Letter Acuity (LCLA) Test Score | Baseline and Weeks 2, 7, and, 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants by Clinical Global Impression-Improvement (CGI-I) (Global Change) Score Categories | Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Patient Global Impression-Improvement (PGI-I) (Global Change) Score Categories | Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by CGI-I (Upper Extremity Functional Change) Score Categories | Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by PGI-I (Upper Extremity Functional Change) Score Categories | Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Clinical Global Impression-Severity (CGI-S) (Global Severity) Score Categories Relative to Baseline | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by Patient Global Impression-Severity (PGI-S) (Global Severity) Score Categories Relative to Baseline | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by CGI-S (Upper Extremity Functional Severity) Score Categories Relative to Baseline | Baseline and Week 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants by PGI-S (Upper Extremity Functional Severity) Score Categories | Baseline and Weeks 2, 7, and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the ADL Component Score for Upper Limb Function Items of the FARS | Baseline and Weeks 2, 7 and 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With at Least a 15 Percent (%) or at Least a 20% Reduction in 9-HPT Completion Time From Baseline | Baseline up to Week 12 | FAS included all randomized participant who received at least 1 dose of the study drug for the treatment period. Number analyzed is the number of participants with data available for analysis at the given time-point. | Participants | COUNT_OF_PARTICIPANTS |
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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GET https://conductscience.org/api/trials/v1/NCT03214588/outcomes