Trial Outcomes & Findings for Subarachnoid Hemorrhage Recovery And Galantamine (NCT NCT02872857)
NCT ID: NCT02872857
Last Updated: 2021-10-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
90 days
Results posted on
2021-10-08
Participant Flow
Participant milestones
| Measure |
Galantamine 8mg During Phase 1
8mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo During Phase 1
Placebo: Placebo will match drug capsules.
|
Galantamine 12mg During Phase 2
12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo During Phase 2
Placebo: Placebo will match drug capsules.
|
|---|---|---|---|---|
|
Phase 1
STARTED
|
15
|
15
|
0
|
0
|
|
Phase 1
COMPLETED
|
15
|
15
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
15
|
15
|
|
Phase 2
COMPLETED
|
0
|
0
|
15
|
15
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subarachnoid Hemorrhage Recovery And Galantamine
Baseline characteristics by cohort
| Measure |
Galantamine
n=30 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=30 Participants
Placebo: Placebo will match drug capsules.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
51.25 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
Outcome measures
| Measure |
Galantamine
n=30 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=30 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Tolerability as Assessed by the Number of Participants Who Stop Study Medication Due to Adverse Event Possibly Associated With Study Drug
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
Outcome measures
| Measure |
Galantamine
n=30 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=30 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Mortality
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Data was not collected for 3 in the galantamine arm and 2 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
The Modified Rankin Score (mRS) is scored as follows: 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Outcome measures
| Measure |
Galantamine
n=27 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=28 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Modified Rankin Score
0
|
3 Participants
|
2 Participants
|
|
Modified Rankin Score
1
|
8 Participants
|
2 Participants
|
|
Modified Rankin Score
2
|
4 Participants
|
12 Participants
|
|
Modified Rankin Score
3
|
3 Participants
|
3 Participants
|
|
Modified Rankin Score
4
|
4 Participants
|
2 Participants
|
|
Modified Rankin Score
5
|
4 Participants
|
3 Participants
|
|
Modified Rankin Score
6
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: baseline (in hospital)Population: Data was not collected for 1 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal.
Outcome measures
| Measure |
Galantamine
n=29 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=24 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
|
7.5 score on a scale
Standard Deviation 9.2
|
8.2 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Data was not collected for 6 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
MoCA scores range between 0 and 30. Higher scores indicate a better outcome, and a score of 26 or over is considered to be normal.
Outcome measures
| Measure |
Galantamine
n=24 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=24 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)
|
14.0 score on a scale
Standard Deviation 11.5
|
15.8 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Data was not collected for 5 in the galantamine arm and 6 in the placebo arm. Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
In the EuroQOL VAS assessment, health status is marked on a 20 cm vertical scale with end points of 0 and 100. 0 corresponds to " the worst health you can imagine," and 100 corresponds to "the best health you can imagine."
Outcome measures
| Measure |
Galantamine
n=25 Participants
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=24 Participants
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
EuroQOL Score as Assessed by a Visual Analogue Scale (VAS)
|
76.2 units on a scale
Standard Deviation 19.4
|
74.0 units on a scale
Standard Deviation 22.6
|
Adverse Events
Galantamine
Serious events: 17 serious events
Other events: 26 other events
Deaths: 1 deaths
Placebo
Serious events: 17 serious events
Other events: 29 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Galantamine
n=30 participants at risk
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=30 participants at risk
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Vascular disorders
Delayed Cerebral Ischemia
|
33.3%
10/30 • Number of events 12 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
40.0%
12/30 • Number of events 15 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Cardiac disorders
Bradycardia
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
10.0%
3/30 • Number of events 3 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Nervous system disorders
Cerebral Edema
|
10.0%
3/30 • Number of events 3 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
10.0%
3/30 • Number of events 3 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Nervous system disorders
Clinical Seizure
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Vascular disorders
Pulmonary Embolism
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Vascular disorders
Angio Complication
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Surgical and medical procedures
Surgical Complication
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
Other adverse events
| Measure |
Galantamine
n=30 participants at risk
8mg or 12mg galantamine twice daily: Drug will be administered within 36 hours of hospitalization and continued for 90 days.
|
Placebo
n=30 participants at risk
Placebo: Placebo will match drug capsules.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
43.3%
13/30 • Number of events 13 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
40.0%
12/30 • Number of events 12 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
12/30 • Number of events 12 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
36.7%
11/30 • Number of events 12 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Cardiac disorders
Bradycardia
|
33.3%
10/30 • Number of events 10 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
40.0%
12/30 • Number of events 12 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
23.3%
7/30 • Number of events 9 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
20.0%
6/30 • Number of events 6 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
23.3%
7/30 • Number of events 7 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
36.7%
11/30 • Number of events 11 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Renal and urinary disorders
Univary Tract Infections
|
30.0%
9/30 • Number of events 9 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
16.7%
5/30 • Number of events 5 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Cardiac disorders
Tachycardia
|
26.7%
8/30 • Number of events 8 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
16.7%
5/30 • Number of events 5 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Renal and urinary disorders
Urinary Retention
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
16.7%
5/30 • Number of events 5 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Vascular disorders
Angio Complication
|
3.3%
1/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
General disorders
Nausea
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/30 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
General disorders
Other
|
66.7%
20/30 • Number of events 36 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
53.3%
16/30 • Number of events 39 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Nervous system disorders
Clinical Seizure
|
3.3%
1/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
6.7%
2/30 • Number of events 2 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
|
Cardiac disorders
Pulmonary Edema
|
3.3%
1/30 • Number of events 1 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
16.7%
5/30 • Number of events 5 • 90 days
Because of the small sample size of this study, which is underpowered to detect differences between the 8mg and 12mg galantamine arms, the pre-specified analysis approach was to combine data for the two galantamine arms when comparing to the placebo arm.
|
Additional Information
HuiMahn Alex Choi, Associate Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-5638
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place