Trial Outcomes & Findings for Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment (NCT NCT00233090)
NCT ID: NCT00233090
Last Updated: 2016-04-15
Results Overview
Self-report of fatigue
TERMINATED
PHASE2
21 participants
comparison pre and post treatment
2016-04-15
Participant Flow
Participant milestones
| Measure |
Modafinil
single dose of 200 mg. a day of modafinil for four weeks
|
Placebo
daily dose of placebo for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment
Baseline characteristics by cohort
| Measure |
Modafinil
n=12 Participants
single dose of 200 mg. a day of modafinil for four weeks
|
Placebo
n=9 Participants
daily dose of placebo for four weeks
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 12 • n=5 Participants
|
54 years
STANDARD_DEVIATION 13 • n=7 Participants
|
53 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
Self-report of fatigue
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
Cognitive performance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
mood
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
pain
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
sleep quality
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
health status
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
participation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: comparison pre and post treatmentPopulation: Study terminated due to low enrollment. data was not analyzed and is no longer available for analysis. Data not kept electronically and study records are no longer available.
quality of life
Outcome measures
Outcome data not reported
Adverse Events
Modafinil
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Wayne A Gordon, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place