Trial Outcomes & Findings for Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage (NCT NCT02330094)
NCT ID: NCT02330094
Last Updated: 2019-09-10
Results Overview
Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
16 participants
Primary outcome timeframe
baseline through day 7
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
Gabapentin
Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
Placebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
Baseline characteristics by cohort
| Measure |
Gabapentin
n=8 Participants
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
n=8 Participants
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
51.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Chronic Pain
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline through day 7Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.
Outcome measures
| Measure |
Gabapentin
n=8 Participants
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
n=8 Participants
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
|---|---|---|
|
Average Numeric Pain Score
|
5.2 score on a scale
Standard Deviation 1.9
|
5.8 score on a scale
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: baseline through day 7The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).
Outcome measures
| Measure |
Gabapentin
n=8 Participants
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
n=8 Participants
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
|---|---|---|
|
Average Narcotic Consumption
|
19.4 milligrams
Standard Deviation 14.8
|
20.2 milligrams
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Day 8The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction.
Outcome measures
| Measure |
Gabapentin
n=8 Participants
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
n=8 Participants
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
|---|---|---|
|
Pain Control Satisfaction Questionnaire
|
14 score on a scale
Standard Deviation 4.1
|
12.6 score on a scale
Standard Deviation 2.9
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=8 participants at risk
Gabapentin capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Gabapentin: Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
Control
n=8 participants at risk
Placebo capsules 100 mg TID, 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID.
Placebo: Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
|
|---|---|---|
|
General disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
|
General disorders
Agitation
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
|
General disorders
Delirium
|
0.00%
0/8 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
|
General disorders
Vomiting
|
0.00%
0/8 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
12.5%
1/8 • Number of events 1 • Adverse event data were collected for the duration of time the subject was in the Neuro Intensive Care Unit, which was an average of 7 to 14 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place