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

Primary Purpose

Friedreich Ataxia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bupropion & Citalopram
Bupropion & Placebo
Placebo & Citalopram
Placebo & Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Friedreich Ataxia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Friedreich Ataxia

Exclusion Criteria:

  • Unable to provide Informed Consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Bupropion & Citalopram

    Bupropion & Placebo

    Placebo & Citalopram

    Placebo & Placebo

    Arm Description

    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

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

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

    Placebo & Placebo taken orally one time per day

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Comparison of FARS and ICARS
    Differences between FARS - ICARS at each treatment interval

    Full Information

    First Posted
    October 25, 2012
    Last Updated
    July 27, 2016
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01716221
    Brief Title
    An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
    Official Title
    An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Friedreich Ataxia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bupropion & Citalopram
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Bupropion & Placebo
    Arm Type
    Active Comparator
    Arm Description
    100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day
    Arm Title
    Placebo & Citalopram
    Arm Type
    Active Comparator
    Arm Description
    Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day
    Arm Title
    Placebo & Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo & Placebo taken orally one time per day
    Intervention Type
    Drug
    Intervention Name(s)
    bupropion & Citalopram
    Intervention Type
    Drug
    Intervention Name(s)
    Bupropion & Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo & Citalopram
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo & Placebo
    Primary Outcome Measure Information:
    Title
    International Cooperative Ataxia Rating Scale (ICARS)
    Description
    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.
    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)
    Title
    Friedreich Ataxia Rating Scale (FARS)
    Description
    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.
    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)
    Secondary Outcome Measure Information:
    Title
    Comparison of FARS and ICARS
    Description
    Differences between FARS - ICARS at each treatment interval
    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)
    Other Pre-specified Outcome Measures:
    Title
    Hamilton Depression Rating Scale
    Description
    The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.
    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)

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Friedreich Ataxia Exclusion Criteria: Unable to provide Informed Consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Olga Klepitskaya, MD
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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