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

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

Detailed Description
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This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.

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

Conditions
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Friedreich Ataxia

Intervention / Treatment
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* Drug: bupropion & Citalopram
* Drug: Bupropion & Placebo
* Drug: Placebo & Citalopram
* Drug: Placebo & Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Friedreich Ataxia Exclusion Criteria: Unable to provide Informed Consent
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupropion & Citalopram<br>100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day | Drug: bupropion & Citalopram<br> <br> |
| Active Comparator: Bupropion & Placebo<br>100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day | Drug: Bupropion & Placebo<br> <br> |
| Active Comparator: Placebo & Citalopram<br>Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day | Drug: Placebo & Citalopram<br> <br> |
| Placebo Comparator: Placebo & Placebo<br>Placebo & Placebo taken orally one time per day | Drug: Placebo & Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Cooperative Ataxia Rating Scale (ICARS) | The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease. | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion) | 
| Friedreich Ataxia Rating Scale (FARS) | A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease. | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of FARS and ICARS | Differences between FARS - ICARS at each treatment interval | Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion) |