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

NCT01716221 | Completed Phase 4 Results

• 1 other identifier: 11-1141
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Friedreich Ataxia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Comparison of FARS and ICARS

  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)

Other Outcomes (1)

• Hamilton Depression Rating Scale

  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)

Study Arms (4)

Bupropion & Citalopram

EXPERIMENTAL

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

Bupropion & Placebo

ACTIVE COMPARATOR

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

Drug: Bupropion & Placebo

Placebo & Citalopram

ACTIVE COMPARATOR

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

Drug: Placebo & Citalopram

Placebo & Placebo

PLACEBO COMPARATOR

Placebo \& Placebo taken orally one time per day

Drug: Placebo & Placebo

Interventions

bupropion & Citalopram DRUG

Bupropion & Citalopram

Bupropion & Placebo DRUG

Bupropion & Placebo

Placebo & Citalopram DRUG

Placebo & Citalopram

Placebo & Placebo DRUG

Placebo & Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Friedreich Ataxia

You may not qualify if:

• Unable to provide Informed Consent

Sponsors & Collaborators

• University of Colorado, Denver: lead

MeSH Terms

Conditions

Friedreich Ataxia

Interventions

Bupropion; Citalopram

Condition Hierarchy (Ancestors)

Spinocerebellar Degenerations; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Olga Klepitskaya
• Organization: University of Colorado

olga.klepitskaya@ucdenver.edu

303-724-8984

Study Officials

• Olga Klepitskaya, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: September 19, 2016
• Results First Posted: September 19, 2016

Record last verified: 2016-07