GRASSP: Gralise® for Spine Surgery Pain

NCT01764464 | Completed Phase 4 Results

• 1 other identifier: RSRB00041904
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-laminectomy Pain Syndrome

Keywords

post laminectomy pain syndrome, failed back surgery syndrome

Outcome Measures

Primary Outcomes (1)

• Mean Change in Numeric Rating Scale (NRS)

  Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).

  baseline to 6 weeks

Secondary Outcomes (5)

• Mean Change in Visual Analog Scale (VAS)

  baseline to 6 weeks

• Mean Change in Patient Global Assessment (PGA)

  baseline to 6 weeks

• Mean McGill Pain Questionnaire-2 (MPQ-2)

  6 weeks

• Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)

  baseline to 6 weeks

• Insomnia Severity Index (ISI)

  6 weeks

Study Arms (2)

Group A

OTHER

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®; Drug: Placebo

Group B

OTHER

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®; Drug: Placebo

Interventions

Gralise® DRUG

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®).

Also known as: Gralise: Gabapentin ER

Group A; Group B

Placebo DRUG

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).

Also known as: Placebo: inactive pill manufactured to mimic gralise.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects age 18 to 80 years.
• 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.
• Pain Detect score ≥12, denoting neuropathic pain is probable.
• At least 50% of present pain intensity is attributed to the lower extremity (Quebec Task Force Grade 3 or 4) on most days.
• All subjects must be decisionally capable and must give their own consent to be enrolled.

You may not qualify if:

• Lumbar surgery \<6 months prior to enrollment
• 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).
• 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).
• Having another type of pain that is as or more severe than pain associated with PLPS.
• An average daily pain score of 10 on the NRS scale during either the screening or initial washout period.
• Concurrent medication that includes antiepileptic drugs (AEDs) (exceptions: pregabalin or gabapentin).
• 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.
• Subjects who have previously not responded to treatment with gabapentin at doses of ≥900 mg/day or pregabalin at doses ≥300 mg/day.
• Known hypersensitivity to Gralise, or gabapentin, or its ingredients.
• Dose limiting adverse events to gabapentin; subjects who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
• History of alcohol and/or drug abuse in the investigator's judgment, based on subject history and physical examination.
• 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.
• Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.
• Gastric reduction surgery.
• Acute gastrointestinal symptoms such as diarrhea, dyspepsia, or gastric or duodenal ulcers.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: John Markman
• Organization: University of Rochester

john_markman@urmc.rochester.edu

585-276-3616

Study Officials

• John Markman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Translational Pain Research

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 30, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Locations

US (1)