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GRASSP: Gralise® for Spine Surgery Pain (GRASSP)

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ClinicalTrials.gov Identifier: NCT01764464
Recruitment Status : Completed
First Posted : January 9, 2013
Results First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
John Markman, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Post-laminectomy Pain Syndrome
Interventions Drug: Gralise®
Drug: Placebo
Enrollment 53
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Group A (Gralise Then Placebo) Group B (Placebo Then Gralise)
Hide Arm/Group Description 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). 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®).
Period Title: First Intervention
Started 16 [1] 16 [2]
Completed 14 [3] 13 [4]
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             1             0
Lost to Follow-up             1             0
Adverse Event             0             2
did not receive study drug             0             1
[1]
Started Gralise
[2]
Started Placebo
[3]
Completed Gralise
[4]
Completed Placebo
Period Title: Second Intervention (Cross-over)
Started 14 [1] 13 [2]
Completed 12 [3] 13 [4]
Not Completed 2 0
Reason Not Completed
Adverse Event             2             0
[1]
Started Placebo
[2]
Started Gralise
[3]
Completed Placebo
[4]
Completed Gralise
Arm/Group Title Group A Group B Total
Hide Arm/Group Description 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). 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 of all reporting groups
Overall Number of Baseline Participants 16 16 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  81.3%
10
  62.5%
23
  71.9%
>=65 years
3
  18.8%
6
  37.5%
9
  28.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Female
7
  43.8%
5
  31.3%
12
  37.5%
Male
9
  56.3%
11
  68.8%
20
  62.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
Hispanic or Latino
1
   6.3%
1
   6.3%
2
   6.3%
Not Hispanic or Latino
15
  93.8%
15
  93.8%
30
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 16 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  12.5%
2
   6.3%
White
16
 100.0%
14
  87.5%
30
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 16 participants 32 participants
16 16 32
1.Primary Outcome
Title Mean Change in Numeric Rating Scale (NRS)
Hide Description Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 32 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.56
(-2.06 to 0.95)
-0.54
(-2.06 to 0.96)
2.Secondary Outcome
Title Mean Change in Visual Analog Scale (VAS)
Hide Description The 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.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 32 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mm
-0.47
(-2.21 to 1.26)
0.31
(-1.42 to 2.05)
3.Secondary Outcome
Title Mean Change in Patient Global Assessment (PGA)
Hide Description Subjects 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.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 32 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.04
(-0.11 to 0.04)
-0.00
(-0.08 to 0.07)
4.Secondary Outcome
Title Mean McGill Pain Questionnaire-2 (MPQ-2)
Hide Description The 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.97  (1.79) 3.13  (1.85)
5.Secondary Outcome
Title Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
Hide Description The 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.
Time Frame baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 32 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-0.07
(-0.21 to 0.06)
-0.07
(-0.21 to 0.07)
6.Secondary Outcome
Title Insomnia Severity Index (ISI)
Hide Description The ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gralise Placebo
Hide Arm/Group Description:
Gralise
Placebo
Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.81  (6.88) 18.40  (7.34)
Time Frame 143 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gralise Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Gralise Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Gralise Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gralise Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/32 (50.00%)   14/32 (43.75%) 
Gastrointestinal disorders     
Diarrhea *  1/32 (3.13%)  2/32 (6.25%) 
General disorders     
Weight gain *  2/32 (6.25%)  0/32 (0.00%) 
peripheral edema *  2/32 (6.25%)  0/32 (0.00%) 
Decreased sex drive *  2/32 (6.25%)  0/32 (0.00%) 
Head cold *  2/32 (6.25%)  2/32 (6.25%) 
Diaphoretic *  1/32 (3.13%)  2/32 (6.25%) 
Musculoskeletal and connective tissue disorders     
Increased Pain *  2/32 (6.25%)  3/32 (9.38%) 
Muscle Cramps *  2/32 (6.25%)  3/32 (9.38%) 
Nervous system disorders     
Dizziness *  4/32 (12.50%)  2/32 (6.25%) 
Somnolence *  7/32 (21.88%)  0/32 (0.00%) 
Headache *  2/32 (6.25%)  2/32 (6.25%) 
Psychiatric disorders     
Depression *  2/32 (6.25%)  1/32 (3.13%) 
Anxiety *  2/32 (6.25%)  2/32 (6.25%) 
Euphoria *  2/32 (6.25%)  0/32 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Markman
Organization: University of Rochester
Phone: 585-276-3616
EMail: john_markman@urmc.rochester.edu
Layout table for additonal information
Responsible Party: John Markman, University of Rochester
ClinicalTrials.gov Identifier: NCT01764464     History of Changes
Other Study ID Numbers: RSRB00041904
First Submitted: January 7, 2013
First Posted: January 9, 2013
Results First Submitted: October 12, 2018
Results First Posted: July 30, 2019
Last Update Posted: July 30, 2019