GRASSP: Gralise® for Spine Surgery Pain
Condition: Post-laminectomy Pain Syndrome
MeSH terms: Syndrome
Intervention: Gralise®; Placebo
Intervention 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®).; 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).
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: post laminectomy pain syndrome, failed back surgery syndrome

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

Eligibility 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.