Trial Outcomes & Findings for Modafinil Treatment for Sleep/Wake Disturbances in Older Adults (NCT NCT00626210)
NCT ID: NCT00626210
Last Updated: 2019-10-28
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
1 month
Results posted on
2019-10-28
Participant Flow
Participant milestones
| Measure |
Modafinil
daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Baseline characteristics by cohort
| Measure |
Modafinil
n=2 Participants
Open label study in which all participants get modafinil
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
Modafinil
n=2 Participants
|
|---|---|
|
Nocturnal Sleep Length at 1 Month
|
9.5 hours
Interval 9.5 to 9.5
|
SECONDARY outcome
Timeframe: ~1 monthOutcome measures
Outcome data not reported
Adverse Events
Modafinil
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