Trial Outcomes & Findings for Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic (NCT NCT02818569)
NCT ID: NCT02818569
Last Updated: 2019-10-02
Results Overview
Number of participants with (1) systolic blood pressure (SBP) \< 60 mmHg, diastolic blood pressure (DBP) \< 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP \> 180 mmHg, DBP \> 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) \< 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.
COMPLETED
PHASE1/PHASE2
15 participants
Active study night, visit 3 or 4
2019-10-02
Participant Flow
All 15 participants completed both arms (dexmedetomidine and placebo) for the study. After being randomized and completing the first arm, patients completed the alternative arm thereafter.
Participant milestones
| Measure |
Oral Dexmedetomidine, Then Placebo
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.
|
Placebo, Then Oral Dexmedetomidine
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine.
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|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=15 Participants
All study participants who were either randomized to receive either Oral Dexmedetomidine or the placebo comparator initially.
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|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Active study night, visit 3 or 4Number of participants with (1) systolic blood pressure (SBP) \< 60 mmHg, diastolic blood pressure (DBP) \< 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP \> 180 mmHg, DBP \> 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) \< 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.
Outcome measures
| Measure |
Oral Dexmedetomidine
n=15 Participants
Dexmedetomidine
Type: Oral
|
Placebo Comparator
n=15 Participants
Placebo Comparator
Type: Saline
|
|---|---|---|
|
Hemodynamic Stability (Phase I)
Bradycardia
|
0 Participants
|
0 Participants
|
|
Hemodynamic Stability (Phase I)
SBP < 60 mmHG
|
0 Participants
|
0 Participants
|
|
Hemodynamic Stability (Phase I)
Hypertension
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Active study night, visit 3 or 4Population: All 15 Participants completed both arms of the study. After being randomized and completing a single arm, they proceeded to complete the second arm thereafter.
Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.
Outcome measures
| Measure |
Oral Dexmedetomidine
n=15 Participants
Dexmedetomidine
Type: Oral
|
Placebo Comparator
n=15 Participants
Placebo Comparator
Type: Saline
|
|---|---|---|
|
Polysomnography Sleep Quality (Phase II).
|
15 participants
|
15 participants
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SECONDARY outcome
Timeframe: Active study night, visit 3 or 4The number of responses that were longer than 400 milliseconds (lapse 400).
Outcome measures
| Measure |
Oral Dexmedetomidine
n=15 Participants
Dexmedetomidine
Type: Oral
|
Placebo Comparator
n=15 Participants
Placebo Comparator
Type: Saline
|
|---|---|---|
|
Performance on the Psychomotor Vigilance Task (Phase II)
Training (Before Sleep)
|
5.8 lapses
Standard Deviation 5
|
6.5 lapses
Standard Deviation 7
|
|
Performance on the Psychomotor Vigilance Task (Phase II)
Testing (After Sleep)
|
14.5 lapses
Standard Deviation 15.5
|
12.3 lapses
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: Active study night, visit 3 or 4Number of participants with improved MST score after sleeping.
Outcome measures
| Measure |
Oral Dexmedetomidine
n=15 Participants
Dexmedetomidine
Type: Oral
|
Placebo Comparator
n=15 Participants
Placebo Comparator
Type: Saline
|
|---|---|---|
|
Performance on the Motor Sequence Task (Phase II)
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Active study night, visit 3 or 4Self-reported sleep latency.
Outcome measures
| Measure |
Oral Dexmedetomidine
n=15 Participants
Dexmedetomidine
Type: Oral
|
Placebo Comparator
n=15 Participants
Placebo Comparator
Type: Saline
|
|---|---|---|
|
Subjective Sleep Quality (Phase II)
|
33 minutes
Standard Deviation 24.4
|
36.3 minutes
Standard Deviation 27.3
|
Adverse Events
Experimental
Placebo Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Oluwaseun Johnson-Akeju
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place