NCT01606176

A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin

A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

Detailed description

Patients with Multiple Sclerosis or other defect of neurological function with a qualifying symptom of chronic refractory pain, entered a seven day baseline period, followed by a 21 day randomised, double blind, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. The ability of the cannabis based medicine extract to relieve chronic refractory pain was assessed by the change from baseline in pain score using Box Scale-11 (BS-11) scores recorded in the patients' daily diary.

Conditions

• Pain
• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	GW-1000-02	Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).
DRUG	Placebo	Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2012-05-25
• Last updated: 2023-01-10
• Results posted: 2012-08-24

Locations

1 site across 1 country: United Kingdom