Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01716221
Other study ID # 11-1141
Secondary ID
Status Completed
Phase Phase 4
First received October 25, 2012
Last updated October 4, 2013
Start date October 2012
Est. completion date March 2013

Study information

Verified date October 2013
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: N/A -

Exclusion Criteria: N/A

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
bupropion & Citalopram

Bupropion & Placebo

Placebo & Citalopram

Placebo & Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Outcome

Type Measure Description Time frame Safety issue
Other Hamilton Depression Rating Scale Baseline and at 5, 10, 15, and 20 weeks Yes
Primary International Cooperative Ataxia Rating Scale (ICARS) Change from Baseline at 5, 10, 15, and 20 weeks No
Primary Friedreich Ataxia Rating Scale (FARS) Change from Baseline at 5, 10, 15, and 20 weeks No
Secondary Comparison of FARS and ICARS Baseline and weeks 5, 10, 15, and 20 scales No
See also
  Status Clinical Trial Phase
Completed NCT05573698 - Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia Phase 1
Completed NCT00229632 - Idebenone to Treat Friedreich's Ataxia Phase 2
Completed NCT05579691 - A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia Phase 2
Completed NCT04273165 - Safety and Efficacy of Etravirine in Friedreich Ataxia Patients Phase 2
Not yet recruiting NCT05874388 - Characterisation of the Cognitive Profile of Patients Suffering From Friedreich's Ataxia N/A
Completed NCT02594917 - Genetic and Environmental Determinants That Control Metabolism in Pulmonary Hypertension
Active, not recruiting NCT05485987 - A Study of Vatiquinone for the Treatment of Participants With Friedreich Ataxia Phase 2
Completed NCT03214588 - Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia Phase 2
Completed NCT03418740 - Neurology Measures in FA Children
Not yet recruiting NCT06054893 - A Study of Omaveloxolone in Children With Friedreich's Ataxia Phase 1
Recruiting NCT04921930 - Evaluation of the Effect of Artesunate in Friedreich Ataxia (FA) Phase 1/Phase 2
Completed NCT03933163 - Micronised Resveratrol as a Treatment for Friedreich Ataxia Phase 2
Completed NCT02705547 - Rosuvastatin (Crestor) in Friedreich Ataxia Early Phase 1
Completed NCT02035020 - A Phase IIa Trial to Test Safety and Efficacy Interferon Gamma Treatment in Elevating Frataxin Levels in FRDA Patients Phase 2
Completed NCT00015808 - Safety Study of Idebenone to Treat Friedreich's Ataxia Phase 1
Completed NCT04817111 - NAD+ Precursor Supplementation in Friedreich's Ataxia Phase 2
Active, not recruiting NCT05168774 - FRDA Investigator Initiated Study (IIS) With Elamipretide Phase 1/Phase 2
Completed NCT03917225 - A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients Phase 2
Completed NCT00224640 - Iron-Chelating Therapy and Friedreich Ataxia Phase 1/Phase 2
Completed NCT00056186 - Transitional Life Events in Patients With Friedreich's Ataxia: Implications for Genetic Counseling N/A