Trial Outcomes & Findings for An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia (NCT NCT01716221)
NCT ID: NCT01716221
Last Updated: 2016-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
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)
Results posted on
2016-09-19
Participant Flow
Participant milestones
| Measure |
Study Participant
the participant received all intervention combinations in the following order: bupropion \& Citalopram, then Bupropion \& Placebo, then Placebo \& Citalopram, then Placebo \& Placebo
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia
Baseline characteristics by cohort
| Measure |
Study Participant
n=1 Participants
the participant received all intervention combinations in the following order: bupropion \& Citalopram, then Bupropion \& Placebo, then Placebo \& Citalopram, then Placebo \& Placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
65 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bupropion & Citalopram
n=1 Participants
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 or 50mg Bupropion \& 10mg Citalopram taken orally one time per day
bupropion \& Citalopram
|
Bupropion & Placebo
n=1 Participants
100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day
Bupropion \& Placebo
|
Placebo & Citalopram
n=1 Participants
Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day
Placebo \& Citalopram
|
Placebo & Placebo
n=1 Participants
Placebo \& Placebo taken orally one time per day
Placebo \& Placebo
|
Baseline
n=1 Participants
unblinded 100mg Bupropion \& 20mg Citalopram
|
|---|---|---|---|---|---|
|
International Cooperative Ataxia Rating Scale (ICARS)
|
39 units
|
30 units
|
47 units
|
46 units
|
42 units
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bupropion & Citalopram
n=1 Participants
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 or 50mg Bupropion \& 10mg Citalopram taken orally one time per day
bupropion \& Citalopram
|
Bupropion & Placebo
n=1 Participants
100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day
Bupropion \& Placebo
|
Placebo & Citalopram
n=1 Participants
Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day
Placebo \& Citalopram
|
Placebo & Placebo
n=1 Participants
Placebo \& Placebo taken orally one time per day
Placebo \& Placebo
|
Baseline
n=1 Participants
unblinded 100mg Bupropion \& 20mg Citalopram
|
|---|---|---|---|---|---|
|
Friedreich Ataxia Rating Scale (FARS)
|
43 points
|
41 points
|
47 points
|
42 points
|
45 points
|
SECONDARY outcome
Timeframe: 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)Differences between FARS - ICARS at each treatment interval
Outcome measures
| Measure |
Bupropion & Citalopram
n=1 Participants
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 or 50mg Bupropion \& 10mg Citalopram taken orally one time per day
bupropion \& Citalopram
|
Bupropion & Placebo
n=1 Participants
100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day
Bupropion \& Placebo
|
Placebo & Citalopram
n=1 Participants
Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day
Placebo \& Citalopram
|
Placebo & Placebo
n=1 Participants
Placebo \& Placebo taken orally one time per day
Placebo \& Placebo
|
Baseline
n=1 Participants
unblinded 100mg Bupropion \& 20mg Citalopram
|
|---|---|---|---|---|---|
|
Comparison of FARS and ICARS
|
1 points
|
-6 points
|
1 points
|
12 points
|
6 points
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Bupropion & Citalopram
n=1 Participants
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 or 50mg Bupropion \& 10mg Citalopram taken orally one time per day
bupropion \& Citalopram
|
Bupropion & Placebo
n=1 Participants
100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day
Bupropion \& Placebo
|
Placebo & Citalopram
n=1 Participants
Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day
Placebo \& Citalopram
|
Placebo & Placebo
n=1 Participants
Placebo \& Placebo taken orally one time per day
Placebo \& Placebo
|
Baseline
n=1 Participants
unblinded 100mg Bupropion \& 20mg Citalopram
|
|---|---|---|---|---|---|
|
Hamilton Depression Rating Scale
|
7 units on a scale
|
10 units on a scale
|
2 units on a scale
|
3 units on a scale
|
4 units on a scale
|
Adverse Events
Bupropion & Citalopram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupropion & Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & Citalopram
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place