Phase 4
N=1
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
Friedreich Ataxia
Bottom Line
View on ClinicalTrials.gov: NCT01716221 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: International Cooperative Ataxia Rating Scale (ICARS) — 39; 30; 47; 46 units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bupropion & Citalopram (Drug); Bupropion & Placebo (Drug); Placebo & Citalopram (Drug); Placebo & Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY International Cooperative Ataxia Rating Scale (ICARS) |
39; 30; 47; 46; 42 | — |
| PRIMARY Friedreich Ataxia Rating Scale (FARS) |
43; 41; 47; 42; 45 | — |
| SECONDARY Comparison of FARS and ICARS |
1; -6; 1; 12; 6 | — |
Summary
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.
Eligibility Criteria
Inclusion Criteria
- Friedreich Ataxia
Exclusion Criteria
- Unable to provide Informed Consent
Data sourced from ClinicalTrials.gov (NCT01716221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.