gw-1000 and Multiple-Sclerosis--Relapsing-Remitting

In addition to muscle stiffness and increasing mobility restrictions, symptoms commonly associated with multiple sclerosis (MS) spasticity are spasms, sleep disturbances, pain, fatigue and bladder dysfunction. Treatment options include trigger factor avoidance, physiotherapy and antispasticity medication. Oral antispasticity agents commonly used in Germany are baclofen, tizanidine and gabapentin, but physician and patient satisfaction with their effectiveness is low. Over the past few years, randomized controlled trials, observational studies and registry data have demonstrated the positive risk:benefit profile of add-on 9-delta-tetra-hydrocannabinol:cannabidiol oromucosal spray for moderate-to-severe resistant MS spasticity. Herein, evidence for this novel therapeutic option is reviewed. A case study illustrates the level of improvement in daily functioning that is possible in treatment responders.

Topics: Administration, Oral; Cannabidiol; Dronabinol; Drug Combinations; Female; Humans; Male; Middle Aged; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Muscle Relaxants, Central; Muscle Spasticity; Observational Studies as Topic; Plant Extracts; Randomized Controlled Trials as Topic

Open-label studies are not ideal for providing robust evidence for long-term maintenance of efficacy of medicines, especially where medicines provide symptom relief and where long-term use of a placebo may be problematic and not ethical.. To evaluate the maintenance of efficacy of Sativex in subjects who have gained long-term symptomatic relief of spasticity in multiple sclerosis (MS), and to assess the impact of sudden medicine withdrawal.. An enriched enrolment randomized withdrawal study design was used. Eligible subjects with ongoing benefit from Sativex for at least 12 weeks entered this 5-week placebo-controlled, parallel-group, randomized withdrawal study. Each subjects' previous effective and tolerated dose was continued.. A total of 18 subjects per group were enrolled. Demographics showed a mean duration of MS of 16.4 years, spasticity 12.7 years, mean duration of Sativex use of 3.6 years (median 3.4 years) and a mean daily dose of 8.25 sprays. Primary outcome of time to treatment failure was significantly in favour of Sativex (p = 0.013). Secondary endpoints showed significant changes in the Carer and Subject's Global Impression of Change scales in favour of Sativex.. Maintenance of Sativex efficacy in long-term symptomatic improvement of spasticity to a group of subjects with MS has been confirmed using this study design.

Topics: Aged; Cannabidiol; Cannabinoids; Dronabinol; Drug Combinations; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Relapsing-Remitting; Muscle Spasticity; Placebos; Plant Extracts; Substance Withdrawal Syndrome