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

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ClinicalTrials.gov Identifier: NCT01716221
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Friedreich Ataxia
Interventions: Drug: bupropion & Citalopram
Drug: Bupropion & Placebo
Drug: Placebo & Citalopram
Drug: Placebo & Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Study Participant the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo

Participant Flow:   Overall Study
    Study Participant
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Study Participant the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo

Baseline Measures
   Study Participant 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   0 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (0) 
Gender 
[Units: Participants]
 
Female   1 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   International Cooperative Ataxia Rating Scale (ICARS)   [ Time Frame: 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) ]

2.  Primary:   Friedreich Ataxia Rating Scale (FARS)   [ Time Frame: 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) ]

3.  Secondary:   Comparison of FARS and ICARS   [ Time Frame: 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) ]

4.  Other Pre-specified:   Hamilton Depression Rating Scale   [ Time Frame: 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Olga Klepitskaya
Organization: University of Colorado
phone: 303-724-8984
e-mail: olga.klepitskaya@ucdenver.edu



Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01716221     History of Changes
Other Study ID Numbers: 11-1141
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: March 11, 2016
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016