CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 53 enrolled
Drug / intervention
Gralise® +1 moredrug
Likely dose
Gralise® 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01764464
NCT01764464Phase 4Completed
CompareCT.gov

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

University of Rochester·interventional·Posted Jan 9, 2013·Updated Jul 30, 2019

In Brief

A Phase 4 clinical trial evaluating Gralise® and Placebo for Post-laminectomy Pain Syndrome. Completed, enrolled 53 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-laminectomy Pain Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 9, 2013
Enrollment StartDec 1, 2012
Primary CompletionMar 1, 2016
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 13.5 years ago

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®).

Placebodrug

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).