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Sponsored by: |
GW Pharmaceuticals Ltd. |
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Information provided by: | GW Pharmaceuticals Ltd. |
ClinicalTrials.gov Identifier: | NCT00702468 |
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®.
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 Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-Term GW-1000-02 (Sativex®). |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Sativex
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Drug: Sativex
containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Dose: 100 µl oromucosal spray, as required for symptom relief
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B: Placebo Comparator
Placebo
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Drug: Placebo
containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%)
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This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving long-term benefit from treatment with Sativex®. Subjects will be selected from the Supply of Unlicensed Sativex® (SUS) or named patient supply programmes and must have been receiving Sativex® for at least 12 weeks prior to study entry. Following informed consent and screening, eligible subjects will enter the study (Visit 1, Day 1) and commence a seven day open label baseline period, before returning for a randomisation visit (Visit 2, Day 7), at which point they are randomised to receive either Sativex® or placebo (randomised withdrawal period). Subjects will return to the centre for an end of study visit at week five (Visit 3, Day 35) or earlier if they withdraw from treatment. Spasticity and sleep disruption review and dosing diaries will be completed each day from the start of the baseline period until completion 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, Norfolk | |
James Paget University Hospital NHS Foundation Trust | |
Gorleston on Sea, Norfolk, United Kingdom, NR31 6LA |
Principal Investigator: | William Notcutt, MB ChB, FRCA | James Paget University Hospital NHS Foundation Trust |
Responsible Party: | GW Pharmaceuticals Ltd. ( Sophie Axford / Senior Clinical Research Associate ) |
Study ID Numbers: | GWSP0702 |
Study First Received: | June 19, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00702468 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Spasticity Multiple Sclerosis |
Autoimmune Diseases Demyelinating Diseases Sclerosis Demyelinating diseases 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 Pathologic Processes Immune System Diseases Nervous System Diseases |