Trial Outcomes & Findings for GRASSP: Gralise® for Spine Surgery Pain (NCT NCT01764464)
NCT ID: NCT01764464
Last Updated: 2019-07-30
Results Overview
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
baseline to 6 weeks
Results posted on
2019-07-30
Participant Flow
53 subjects signed consent and were enrolled in the study. 22 subjects were ineligible after enrollment for the following: did not meet inclusion/exclusion criteria (n=12), withdrew consent during screening period (n=5), non-responder to gabapentinoid during washout period (n=5). A total of 32 subjects were randomized, 25 completed.
Participant milestones
| Measure |
Group A (Gralise Then Placebo)
14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
|
Group B (Placebo Then Gralise)
14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
16
|
|
First Intervention
COMPLETED
|
14
|
13
|
|
First Intervention
NOT COMPLETED
|
2
|
3
|
|
Second Intervention (Cross-over)
STARTED
|
14
|
13
|
|
Second Intervention (Cross-over)
COMPLETED
|
12
|
13
|
|
Second Intervention (Cross-over)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group A (Gralise Then Placebo)
14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
|
Group B (Placebo Then Gralise)
14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
1
|
0
|
|
First Intervention
Lost to Follow-up
|
1
|
0
|
|
First Intervention
Adverse Event
|
0
|
2
|
|
First Intervention
did not receive study drug
|
0
|
1
|
|
Second Intervention (Cross-over)
Adverse Event
|
2
|
0
|
Baseline Characteristics
GRASSP: Gralise® for Spine Surgery Pain
Baseline characteristics by cohort
| Measure |
Group A
n=16 Participants
14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
|
Group B
n=16 Participants
14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 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
|
|
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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 6 weeksUsing the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
Outcome measures
| Measure |
Gralise
n=32 Participants
Gralise
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Mean Change in Numeric Rating Scale (NRS)
|
-0.56 units on a scale
Interval -2.06 to 0.95
|
-0.54 units on a scale
Interval -2.06 to 0.96
|
SECONDARY outcome
Timeframe: baseline to 6 weeksThe VAS asks subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Outcome measures
| Measure |
Gralise
n=32 Participants
Gralise
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Mean Change in Visual Analog Scale (VAS)
|
-0.47 mm
Interval -2.21 to 1.26
|
0.31 mm
Interval -1.42 to 2.05
|
SECONDARY outcome
Timeframe: baseline to 6 weeksSubjects will be asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA is measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Outcome measures
| Measure |
Gralise
n=32 Participants
Gralise
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Mean Change in Patient Global Assessment (PGA)
|
-0.04 units on a scale
Interval -0.11 to 0.04
|
-0.00 units on a scale
Interval -0.08 to 0.07
|
SECONDARY outcome
Timeframe: 6 weeksThe McGill Pain questionnaire is 22 questions where patient rate their pain symptoms with each question scaled 0-10 for a total 220 points where a higher score indicates worse outcome.
Outcome measures
| Measure |
Gralise
n=27 Participants
Gralise
|
Placebo
n=25 Participants
Placebo
|
|---|---|---|
|
Mean McGill Pain Questionnaire-2 (MPQ-2)
|
2.97 units on a scale
Standard Deviation 1.79
|
3.13 units on a scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: baseline to 6 weeksThe mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). The scale ranges from 0 to 70. Higher scores indicate worse outcome.
Outcome measures
| Measure |
Gralise
n=32 Participants
Gralise
|
Placebo
n=32 Participants
Placebo
|
|---|---|---|
|
Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
|
-0.07 units on a scale
Interval -0.21 to 0.06
|
-0.07 units on a scale
Interval -0.21 to 0.07
|
SECONDARY outcome
Timeframe: 6 weeksThe ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia.
Outcome measures
| Measure |
Gralise
n=27 Participants
Gralise
|
Placebo
n=25 Participants
Placebo
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
16.81 units on a scale
Standard Deviation 6.88
|
18.40 units on a scale
Standard Deviation 7.34
|
Adverse Events
Gralise
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gralise
n=32 participants at risk
|
Placebo
n=32 participants at risk
|
|---|---|---|
|
General disorders
Weight gain
|
6.2%
2/32 • 143 days
|
0.00%
0/32 • 143 days
|
|
General disorders
peripheral edema
|
6.2%
2/32 • 143 days
|
0.00%
0/32 • 143 days
|
|
General disorders
Decreased sex drive
|
6.2%
2/32 • 143 days
|
0.00%
0/32 • 143 days
|
|
General disorders
Head cold
|
6.2%
2/32 • 143 days
|
6.2%
2/32 • 143 days
|
|
General disorders
Diaphoretic
|
3.1%
1/32 • 143 days
|
6.2%
2/32 • 143 days
|
|
Psychiatric disorders
Depression
|
6.2%
2/32 • 143 days
|
3.1%
1/32 • 143 days
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • 143 days
|
6.2%
2/32 • 143 days
|
|
Psychiatric disorders
Euphoria
|
6.2%
2/32 • 143 days
|
0.00%
0/32 • 143 days
|
|
Musculoskeletal and connective tissue disorders
Increased Pain
|
6.2%
2/32 • 143 days
|
9.4%
3/32 • 143 days
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
6.2%
2/32 • 143 days
|
9.4%
3/32 • 143 days
|
|
Nervous system disorders
Dizziness
|
12.5%
4/32 • 143 days
|
6.2%
2/32 • 143 days
|
|
Nervous system disorders
Somnolence
|
21.9%
7/32 • 143 days
|
0.00%
0/32 • 143 days
|
|
Nervous system disorders
Headache
|
6.2%
2/32 • 143 days
|
6.2%
2/32 • 143 days
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • 143 days
|
6.2%
2/32 • 143 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place