NCT01764464

GRASSP: Gralise® for Spine Surgery Pain

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Post-laminectomy Pain Syndrome

Interventions

Type	Name	Description
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®).
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).

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2013-01-09
• Last updated: 2019-07-30
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States