An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia

Friedreich Ataxia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716221
• Other study ID #: 11-1141
• 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

• Ataxia
• Friedreich Ataxia

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