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

NCT ID: NCT01716221

Last Updated: 2016-09-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-03-31

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.

Conditions

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Friedreich Ataxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bupropion & Citalopram

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

Group Type EXPERIMENTAL

bupropion & Citalopram

Intervention Type DRUG

Bupropion & Placebo

100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day

Group Type ACTIVE_COMPARATOR

Bupropion & Placebo

Intervention Type DRUG

Placebo & Citalopram

Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day

Group Type ACTIVE_COMPARATOR

Placebo & Citalopram

Intervention Type DRUG

Placebo & Placebo

Placebo \& Placebo taken orally one time per day

Group Type PLACEBO_COMPARATOR

Placebo & Placebo

Intervention Type DRUG

Interventions

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bupropion & Citalopram

Intervention Type DRUG

Bupropion & Placebo

Intervention Type DRUG

Placebo & Citalopram

Intervention Type DRUG

Placebo & Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Friedreich Ataxia

Exclusion Criteria

* Unable to provide Informed Consent
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga Klepitskaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Other Identifiers

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11-1141

Identifier Type: -

Identifier Source: org_study_id

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