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

NCT01610687 | Completed Phase 3 Results

• 1 other identifier: GWMS0001 EXT
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Spasticity

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events as a Measure of Patient Safety

  The number of patients who experienced an adverse event during the course of this extension study is presented

  up to1206 days

Secondary Outcomes (7)

• Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment

  up to 1206 days

• Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.

  18 weeks

• Investigator Assessed Global Severity Score at Week 18

  week 18

• Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18

  week 18

• Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18

  week 18

Study Arms (1)

GW-1000-02

EXPERIMENTAL

Active treatment

Drug: GW-1000-02

Interventions

GW-1000-02 DRUG

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.

Also known as: Sativex

GW-1000-02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years.
• Multiple Sclerosis of any type.
• Stable Multiple Sclerosis symptomatology during the four weeks before study entry.
• Symptoms of the required severity (\>50 mm on a 100 mm Visual Analogue Scale severity scale) in least one of the specified impairment categories; spasticity, muscle spasms, disturbed bladder control, neuropathic pain, limb tremor.
• A stable medication regime during the four weeks before study entry.
• Willing to abstain from cannabis or cannabinoids for at least seven days before study entry, and during the study.
• Agreed either to use effective contraception during the study and for three months thereafter, or had been surgically sterilised or, if female, were post-menopausal.
• Clinically acceptable laboratory results for pre-study screening.
• Willing and able to undertake and comply with all study requirements.
• Willing and able to read, consider and understand the subject information and consent form and give written informed consent. Subjects unable to read or to sign the document procedures were treated as detailed in the Declaration of Helsinki.
• Willing for their general practitioner, and consultant if appropriate, to be informed of study participation.
• Willing for their name to be notified to Home Office for participation in the study.

You may not qualify if:

• Known or strongly suspected to be abusing drugs, including alcohol.
• Not prepared to abstain from cannabis or cannabinoids during the study.
• Current or past addiction to cannabis.
• Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness.
• History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness or personality disorder other than depression associated with chronic illness.
• Received any drug containing levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®).
• Serious cardiovascular disorder including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia.
• Significant renal or hepatic impairment as shown in medical history or indicated by laboratory results.
• History of epilepsy.
• Terminal illness or other condition in which placebo medication would be inappropriate.
• Pregnant, lactating or at risk of pregnancy.
• Participated in any other clinical research study during the 12 weeks before study entry.
• Planned hospital admission between study entry and Visit 6.
• Planned travel outside the UK between study entry and Visit 6.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Rivermead Rehabilitation Centre

Oxford, OX3 7LD, United Kingdom

Location

Related Publications (1)

• Wade DT, Makela PM, House H, Bateman C, Robson P. Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Mult Scler. 2006 Oct;12(5):639-45. doi: 10.1177/1352458505070618.

  PMID: 17086911 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma Ltd.

rp@gwpharm.com

0044 1223 266800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: July 1, 2001
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: January 10, 2023
• Results First Posted: August 17, 2012

Record last verified: 2022-12

Locations

GB (1)