GRASSP: Gralise® for Spine Surgery Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
John Markman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01764464
First received: January 7, 2013
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)


Condition Intervention Phase
Post-laminectomy Pain Syndrome
Drug: Gralise®
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Gralise® for Spine Surgery Pain (GRASSP): A Partially Enriched, Placebo Controlled, Randomized, Double Blind, Cross-Over Trial of Gralise® for the Treatment of Post Laminectomy Pain Syndrome

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Numeric Rating Scale (NRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).


Secondary Outcome Measures:
  • Visual Analog Scale (VAS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Global Assessment (PGA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • McGill Pain Questionnaire-2 (MPQ-2) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Modified Brief Pain Inventory- short form (mBPI-sf) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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). For the interference score, a total of 70 indicates pain completely interferes with activities.

  • Insomnia Severity Index (ISI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group A
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).
Drug: Gralise®
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®).
Other Name: Gralise: Gabapentin ER
Drug: 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).
Other Name: Placebo: inactive pill manufactured to mimic gralise.
Group B
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®).
Drug: Gralise®
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®).
Other Name: Gralise: Gabapentin ER
Drug: 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).
Other Name: Placebo: inactive pill manufactured to mimic gralise.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria.

  1. Male and female subjects age 18 to 80 years.
  2. Primary diagnosis of post-laminectomy pain syndrome (PLPS), defined as having their most severe pain related to a prior history of lumbar surgery including decompressive (e.g. laminectomy) or fusion (e.g. posterior lumbar interbody fusion) procedures performed from the L1-S1 level at least 6 months prior to enrollment.
  3. Pain Detect score ≥12, denoting neuropathic pain is probable.
  4. At least 50% of present pain intensity is attributed to the lower extremity (Quebec Task Force Grade 3 or 4) on most days.
  5. All subjects must be decisionally capable and must give their own consent to be enrolled.

Exclusion Criteria.

  1. Lumbar surgery <6 months prior to enrollment
  2. Subjects with PLPS and pain free interval (defined as chronic low back pain and radicular symptoms <=3/10) related the indication for their PLPS defining event and a new, acute or subacute symptom pattern (e.g. new disc herniation at an adjacent level as documented by imaging).
  3. Subjects regularly taking gabapentin or pregabalin for their chronic pain after spine surgery who do not endorse relief (defined as either minimally, much or very much improved on a 7 point likert scale when asked about these medications' effects).
  4. Having another type of pain that is as or more severe than pain associated with PLPS.
  5. An average daily pain score of 10 on the NRS scale during either the screening or initial washout period.
  6. Concurrent medication that includes antiepileptic drugs (AEDs) (exceptions: pregabalin or gabapentin).
  7. Subjects taking concomitant neuropathic pain medication (stable dose for at least 4 weeks) may reduce the number and/or dose of their current pain medications: If the number and/or dose exceed the limits of allowed neuropathic pain medications (refer to Use of Allowed Pain Medication), then the number and/or dose must be reduced to fall within acceptable limits. Concomitant neuropathic pain medication needs to be kept stable during the study.
  8. Subjects who have previously not responded to treatment with gabapentin at doses of ≥900 mg/day or pregabalin at doses ≥300 mg/day.
  9. Known hypersensitivity to Gralise, or gabapentin, or its ingredients.
  10. Dose limiting adverse events to gabapentin; subjects who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
  11. History of alcohol and/or drug abuse in the investigator's judgment, based on subject history and physical examination.
  12. Subject who consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [10 ounces], wine [4 ounces], or distilled spirits [1 ounce]) per day on a regular basis.
  13. Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.
  14. Gastric reduction surgery.
  15. Acute gastrointestinal symptoms such as diarrhea, dyspepsia, or gastric or duodenal ulcers.
  16. Malignancy within past 2 years other than basal cell carcinoma.
  17. Women who are pregnant or breastfeeding.
  18. History of seizure or is at risk of seizure due to head trauma.
  19. History of significant cardiovascular, respiratory, endocrine, liver or kidney disease (subjects with renal impairment or creatine clearance <30 ml/min).
  20. Any significant medical condition, laboratory abnormality, or psychiatric illness (e.g. depression, mood problems, suicidal thoughts) that would prevent the subject from participating in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764464

Contacts
Contact: John Markman, MD 585-340-8926 john_markman@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14618
Contact: John Markman, MD    585-340-8926    john_markman@urmc.rochester.edu   
Principal Investigator: John Markman, MD         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: John Markman, MD University of Rochester
  More Information

No publications provided

Responsible Party: John Markman, Director, Translational Pain Research, University of Rochester
ClinicalTrials.gov Identifier: NCT01764464     History of Changes
Other Study ID Numbers: RSRB00041904
Study First Received: January 7, 2013
Last Updated: April 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
post laminectomy pain syndrome, failed back surgery syndrome

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 18, 2014