Trial · NCT07185347
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of patients showing an improvement of at least 0.5 point on the Friedreich's Ataxia Rating Scale (FARS) -Functional Staging at week 12 | At week 12 | |
| Secondary | Improvement of at least 0.5 point on the Friedreich's Ataxia Rating Scale (FARS) -Functional Staging at week 2 | At week 2 | |
| Secondary | Variation in cerebellar syndrome assessed by the Scale for the assessment and rating of ataxia (SARA) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in cerebellar syndrome assessed by the modified Friedreich Ataxia Rating Scale (mFARS) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in cerebellar syndrome assessed by the Composite Cerebellar Functional Severity Score (CCFS score) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in extracerebellar signs assessed by the Inventory of Non-Ataxia Signs (INAS) at week 12 | At week 12 | |
| Secondary | Variation on Timed 25-foot walk (T25FW) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in oculomotor signs assessed by the Scale for Ocular motor Disorders in Ataxia (SODA) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in oculomotor signs assessed by oculomotor recording (OMR) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in daily frequency of diplopia assessed on a Numerical Diplopia Rating Scale (NDRS) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Variation in daily living activities evaluated by the FARS -Activities of Daily Living scale (FARS-ADL) at week 12 | At week 12 | |
| Secondary | Quality of life evaluated by the Patient Reported Outcome Measure of Ataxia (PROM-ATAXIA) questionnaire at week 12 | At week 12 | |
| Secondary | Quality of life evaluated by the 36-Item Short Form Health Survey (SF-36) questionnaire at week 12 | At week 12 | |
| Secondary | Patient's impression evaluated by the Patient Global Impression of change (PGI-C) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Clinician's impression evaluated by the Clinician Global Impression of Change (CGI-C) at week 2 and week 12 | At week 2 and week 12 | |
| Secondary | Tolerance to the investigational drug | At week 2 and week 12 | Tolerance will be evaluated through clinical examination, blood analysis, and electrocardiogram (ECG) performed at Week 2 and Week 12. In addition, adverse events will be systematically recorded throughout the study period. |
| Secondary | Clinical assessments at week 16, i.e. 4 weeks after treatment interruption | At week 16 | |
| Secondary | Variation in cerebellar syndrome assessed by the FARS-Functional Staging at week 16, i.e. 4 weeks after treatment interruption | At week 16 | |
| Secondary | Variation in cerebellar syndrome assessed by the SARA scale at week 16, i.e. 4 weeks after treatment interruption | At week 16 | |
| Secondary | Variation in cerebellar syndrome assessed by the mFARS scale at week 16, i.e. 4 weeks after treatment interruption | At week 16 |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07185347/registered