An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis

NCT01610713 | Completed Phase 3 Results

• 1 other identifier: GWMS0001 Part B
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label extension study in which patients with multiple sclerosis received GW-1000-02 \[named Sativex® in Canada and also named Sativex® Oromucosal Spray\] for four weeks in an open-label manner.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)

  This was achieved by measuring the change in the Part A study score (mean of all scores during the last two weeks of six weeks of double-blind therapy) in the severity of the primary impairment (mean of all scores during the last two weeks of four weeks of open-label therapy), 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. As such, a decrease in score indicates an improvement and a negative value indicates an improvement in score from baseline.

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

Secondary Outcomes (25)

• Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

• Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

• Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

• Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

• Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment

  End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

Study Arms (1)

GW-1000-02

EXPERIMENTAL

Active treatment.

Drug: GW-1000-02

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

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, United Kingdom

Location

Related Publications (2)

• 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

• Di Marzo V, Centonze D. Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes. CNS Neurosci Ther. 2015 Mar;21(3):215-21. doi: 10.1111/cns.12358. Epub 2014 Dec 4.

  PMID: 25475413 DERIVED

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: 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: May 1, 2001
• Primary Completion: July 1, 2002
• Study Completion: July 1, 2002
• Last Updated: January 10, 2023
• Results First Posted: September 19, 2012

Record last verified: 2022-12

Locations

GB (1)