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Sponsored by: |
GW Pharmaceuticals Ltd. |
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Information provided by: | GW Pharmaceuticals Ltd. |
ClinicalTrials.gov Identifier: | NCT00711646 |
The purpose of this study is t to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity.
Condition | Intervention | Phase |
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Spasticity Multiple Sclerosis |
Drug: Sativex® Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind, Randomised, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Cannabis Based Medicine 1:1 THC:CBD Compared With Placebo for the Treatment of Spasticity in Patients With Multiple Sclerosis. |
Enrollment: | 189 |
Study Start Date: | June 2002 |
Study Completion Date: | March 2004 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Sativex®
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
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2: Placebo Comparator |
Drug: Placebo
containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.
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This was an eight week (two weeks baseline, six weeks treatment), multicentre, double blind, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Oxfordshire | |
Royal Berkshire Hospital | |
Reading, Oxfordshire, United Kingdom, RG1 5AN |
Principal Investigator: | Christine Collin, MB BS MRCP FRCP | Royal Berkshire Hospital |
Responsible Party: | GW Pharmaceuticals Ltd. ( Mr Richard Potts/ Clinical Operations Director ) |
Study ID Numbers: | GWMS0106 |
Study First Received: | July 8, 2008 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00711646 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Romania: National Medicines Agency |
Spasticity Multiple Sclerosis |
Autoimmune Diseases Demyelinating Diseases Sclerosis Signs and Symptoms Muscle Spasticity Multiple Sclerosis Muscular Diseases |
Musculoskeletal Diseases Muscle Hypertonia Demyelinating Autoimmune Diseases, CNS Neurologic Manifestations Autoimmune Diseases of the Nervous System Ethanol |
Neuromuscular Manifestations Autoimmune Diseases Demyelinating Diseases Immune System Diseases Nervous System Diseases Sclerosis Signs and Symptoms Muscle Spasticity |
Pathologic Processes Multiple Sclerosis Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |