NCT01610687

A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

A Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.

Detailed description

Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.

Conditions

• Multiple Sclerosis
• Spasticity

Interventions

Type	Name	Description
DRUG	GW-1000-02	Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.

Timeline

• Start date: 2001-07-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2012-06-04
• Last updated: 2023-01-10
• Results posted: 2012-08-17

Locations

1 site across 1 country: United Kingdom