Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis|
- Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
- Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
- Effect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory
|Study Start Date:||September 2001|
|Estimated Study Completion Date:||March 2005|
Studies of cannabinoids for spasticity in MS have had mixed results but clinical studies have been small, generally not properly controlled, with results controversial, and difficult to interpret. Recently, investigators in the UK and US tested the ability of cannabinoids to control spasticity and tremor symptoms of the MS-like disease, experimental allergic encephalomyelitis, in mice (Baker et al, 2000). The authors found that four different cannabinoids quantitatively ameliorated both tremor and spasticity in diseased mice; thus providing rationale for patients' reports of the therapeutic effects of cannabis in the control of their MS symptoms.
The present study will be a randomized, placebo-controlled, crossover design of 30 patients who will be assessed before and after treatment for 3 consecutive days (Phase I), undergo washout-out for a total of 11 days, and then cross over to either the placebo or active treatment phase (Phase II), depending on what they received during Phase I. At each study visit, patients will utilize a controlled puff procedure to help ensure stable intake (Levin et al, 1989).
Comparisons: A single dose of 4% THC marijuana cigarette each day for 3 days will be compared to a placebo administered under the same dosing conditions for the relief of spasticity, drug tolerability, and changes in global functioning and quality of life indices.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248378
|United States, California|
|UC San Diego Medical Center|
|San Diego, California, United States, 92093|
|Principal Investigator:||Jody Corey-Bloom, M.D., Ph.D.||University of California, San Diego|