Trial Outcomes & Findings for Feasibility Study on the Use of Redormin®500 on Day-time Cognition (NCT NCT05684523)
NCT ID: NCT05684523
Last Updated: 2026-06-11
Results Overview
Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
21 days
Results posted on
2026-06-11
Participant Flow
40 healthy volunteers (male and female) between 18 and 65 with occasional sleep problems, defined as sleep disturbances occurring on average 1-2 nights per week, with a Pittsburgh sleep quality index (PSQI) score greater than 5.
Participant milestones
| Measure |
Placebo
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
18 Participants
n=18 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=22 Participants
|
10 Participants
n=18 Participants
|
22 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=22 Participants
|
8 Participants
n=18 Participants
|
18 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Sleep parameters
Total sleep duration
|
6.76 hours
STANDARD_DEVIATION 0.88 • n=22 Participants
|
6.61 hours
STANDARD_DEVIATION 0.69 • n=18 Participants
|
6.69 hours
STANDARD_DEVIATION 0.79 • n=40 Participants
|
|
Sleep parameters
Total duration in bed during the night
|
7.78 hours
STANDARD_DEVIATION 1.10 • n=22 Participants
|
7.61 hours
STANDARD_DEVIATION 0.89 • n=18 Participants
|
7.70 hours
STANDARD_DEVIATION 1.00 • n=40 Participants
|
|
Working memory
|
8.98 total number of correct responses
STANDARD_DEVIATION 2.43 • n=22 Participants
|
8.61 total number of correct responses
STANDARD_DEVIATION 2.2 • n=18 Participants
|
8.80 total number of correct responses
STANDARD_DEVIATION 2.32 • n=40 Participants
|
|
Reaction time
|
377.92 Milliseconds
STANDARD_DEVIATION 102.98 • n=22 Participants
|
403.74 Milliseconds
STANDARD_DEVIATION 93.91 • n=18 Participants
|
390.83 Milliseconds
STANDARD_DEVIATION 98.44 • n=40 Participants
|
PRIMARY outcome
Timeframe: 21 daysDescriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey
Outcome measures
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: each day for 21 daysTotal sleep duration as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.
Outcome measures
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Total Sleep Duration Per Day
|
6.46 hours per day
Standard Deviation 0.74
|
6.73 hours per day
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: each day for 21 daysTotal duration in bed as measured with Fitbit device at each day for 21 days. The outcome reported is based on individual means over 21 days.
Outcome measures
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Total Duration in Bed Per Day
|
7.40 hours per day
Standard Deviation 0.84
|
7.72 hours per day
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: each day for 21 daysThe "Digit Span Backward" task was part of the SoSci-Survey as obtained at each day for 21 days. Twelve digits were presented to the participants at each timepoint. Measured were the correctly remembered digits per timepoint (Range 0-12). The outcome reported is based on individual means over 21 days.
Outcome measures
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Working Memory at Daytime: Number of Correctly Remembered Digits
|
9.06 Number of correct responses per day
Standard Deviation 2.49
|
9.03 Number of correct responses per day
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: each day for 21 daysBased on the "Red Button Task" task which was part of the SoSci-Survey as obtained at each day for 21 days. A gray circle was presented on a screen. The circle changed the color to red, and the participants had to push a button as soon as they noticed the change. Reaction time was measured in milliseconds. The outcome reported is based on individual means over 21 days.
Outcome measures
| Measure |
Placebo
n=22 Participants
22 healthy volunteers receiving a matching placebo, 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
Verum (Ze 91019)
n=18 Participants
18 healthy volunteers receiving verum (Ze 91019 = Redormin 500), 1 tablet, once daîly, 1 hour before bedtime for 21 days
|
|---|---|---|
|
Reaction Time at Daytime
|
378.38 milliseconds per individual test
Standard Deviation 110.45
|
401.59 milliseconds per individual test
Standard Deviation 84.70
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Verum (Ze 91019)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=22 participants at risk
22 healthy volunteers receiving placebo
|
Verum (Ze 91019)
n=18 participants at risk
18 healthy volunteers receiving verum (Ze 91019)
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.1%
2/22 • Adverse events as collected during the treatment phase of 21 days
|
5.6%
1/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Viral rhinitis
|
9.1%
2/22 • Adverse events as collected during the treatment phase of 21 days
|
11.1%
2/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Flu-like infection
|
0.00%
0/22 • Adverse events as collected during the treatment phase of 21 days
|
5.6%
1/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Covid-19 infection
|
0.00%
0/22 • Adverse events as collected during the treatment phase of 21 days
|
5.6%
1/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22 • Adverse events as collected during the treatment phase of 21 days
|
5.6%
1/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/22 • Adverse events as collected during the treatment phase of 21 days
|
5.6%
1/18 • Adverse events as collected during the treatment phase of 21 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.5%
1/22 • Adverse events as collected during the treatment phase of 21 days
|
11.1%
2/18 • Adverse events as collected during the treatment phase of 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place