An Investigation of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis Patients

NCT01610700 | Completed Phase 3 Results

• 1 other identifier: GWMS0001 Part A
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

A study to compare the efficacy of GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] with placebo in relieving five key symptoms of Multiple Sclerosis after six weeks of therapy.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Composite Primary Impairment Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  This was achieved by measuring the change from baseline after six weeks of therapy in the severity of the primary impairment, a composite score from one of five Multiple Sclerosis symptom categories that subjects nominated as their most severe symptom. The severity scores were recorded using a 100 mm Visual Analogue Scale, where 0 = no problem and 100 = very bad. A decrease in score indicates an improvement.

  baseline and 6 weeks

Secondary Outcomes (24)

• Change From Baseline in Spasticity Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  baseline and 6 weeks

• Change From Baseline in Pain Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  baseline and 6 weeks

• Change From Baseline in Muscle Spasm Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  baseline and 6 weeks

• Change From Baseline in Tremor Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  baseline and 6 weeks

• Change From Baseline in Bladder Problems Visual Analogue Scale Score at the End of 6 Weeks of Treatment

  baseline and 6 weeks

Study Arms (2)

GW-1000-02

EXPERIMENTAL

Active treatment

Drug: GW-1000-02

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo

Interventions

GW-1000-02 DRUG

Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication 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

Placebo DRUG

Each actuation of placebo delivered the excipients only.

Placebo

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 P, Robson P, House H, Bateman C. Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Mult Scler. 2004 Aug;10(4):434-41. doi: 10.1191/1352458504ms1082oa.

  PMID: 15327042 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

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

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 4, 2012
• Study Start: May 1, 2001
• Primary Completion: July 1, 2002
• Study Completion: July 1, 2002
• Last Updated: January 12, 2023
• Results First Posted: September 19, 2012

Record last verified: 2022-12

Locations

GB (1)