Friedreich AtaxiaPhase 4NCT01716221
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
A Phase 4 study testing bupropion & Citalopram in people with Friedreich Ataxia, run by University of Colorado, Denver.
Trial summary
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Friedreich Ataxia
- What is being tested?
- bupropion & Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Friedreich Ataxia
Who cannot join
- Unable to provide Informed Consent
About this study
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.
Read the 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.
- Conditions
- Friedreich Ataxia
- Being tested
- bupropion & Citalopram, Bupropion & Placebo, Placebo & Citalopram, Placebo & Placebo
- Medical subject headings
- Friedreich Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion & CitalopramDrug
Bupropion & PlaceboDrug
Placebo & CitalopramDrug
Placebo & PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo & Citalopram |
| Placebo & Placebo | Placebo comparator | Placebo \& Placebo taken orally one time per day Receives: Drug: Placebo & Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Differences between FARS - ICARS at each treatment interval
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Friedreich AtaxiaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Klepitskaya, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716221
- Sponsor's protocol ID
- 11-1141
- Status last verified
- Jul 2016
- First submitted
- 25 Oct 2012
- Last updated
- 19 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
- ClinicalTrials.gov ID
- NCT01716221
- Acronym / sponsor ID
- 11-1141
- Conditions
- Friedreich Ataxia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Posted 19 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bupropion & Citalopram | Experimental | Drug: bupropion & Citalopram100mg 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 |
| Bupropion & Placebo | Active comparator | Drug: Bupropion & Placebo100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day |
| Placebo & Citalopram | Active comparator | Drug: Placebo & CitalopramPlacebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day |
| Placebo & Placebo | Placebo comparator | Drug: Placebo & PlaceboPlacebo \& Placebo taken orally one time per day |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Friedreich Ataxia
Key exclusion criteria (1 listed)
- Unable to provide Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion & Citalopram | Drug | Bupropion & Citalopram |
| Bupropion & Placebo | Drug | Bupropion & Placebo |
| Placebo & Citalopram | Drug | Placebo & Citalopram |
| Placebo & Placebo | Drug | Placebo & Placebo |
Primary outcome
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)
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)
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)
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Klepitskaya, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion & Citalopram in people with Friedreich Ataxia, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.