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

NCT ID: NCT01610700

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2002-07-31

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.

Detailed Description

Eligible subjects entered a one to two week baseline period; followed by a six week double blind, randomised, parallel group comparison of GW-1000-02 with placebo, self-titrated to symptom resolution or maximum tolerated dose. Existing medication continued at a constant dose.

Primary efficacy comparisons were made between symptom scores recorded during baseline and scores recorded at the end of the parallel group period.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GW-1000-02

Active treatment

Group Type: EXPERIMENTAL

GW-1000-02

Intervention Type: 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.

Placebo

Control

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Each actuation of placebo delivered the excipients only.

Interventions

GW-1000-02

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.

Intervention Type: DRUG

Placebo

Each actuation of placebo delivered the excipients only.

Intervention Type: DRUG

Other Intervention Names

Sativex

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rivermead Rehabilitation Centre

Oxford, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 15327042 (View on PubMed)

Other Identifiers

GWMS0001 Part A

Identifier Type: -

Identifier Source: org_study_id