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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01716221
First received: October 25, 2012
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Friedreich Ataxia
Drug: bupropion & Citalopram
Drug: Bupropion & Placebo
Drug: Placebo & Citalopram
Drug: Placebo & Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • International Cooperative Ataxia Rating Scale (ICARS) [ Time Frame: Change from Baseline at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: No ]
  • Friedreich Ataxia Rating Scale (FARS) [ Time Frame: Change from Baseline at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of FARS and ICARS [ Time Frame: Baseline and weeks 5, 10, 15, and 20 scales ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Baseline and at 5, 10, 15, and 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: bupropion & Citalopram
Active Comparator: Bupropion & Placebo
100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
Drug: Bupropion & Placebo
Active Comparator: Placebo & Citalopram
Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
Drug: Placebo & Citalopram
Placebo Comparator: Placebo & Placebo
Placebo & Placebo taken orally one time per day
Drug: Placebo & Placebo

  Eligibility

Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: N/A -

Exclusion Criteria: N/A

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716221

Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Drew Kern, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01716221     History of Changes
Other Study ID Numbers: 11-1141
Study First Received: October 25, 2012
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ataxia
Friedreich Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinocerebellar Degenerations
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mitochondrial Diseases
Metabolic Diseases
Citalopram
Bupropion
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014