Short-Term Effects of Medicinal Cannabis Therapy on Spasticity in Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Smoked Cannabis
What it measured
Main measures
Reduction in spasticity as indicated by the: Ashworth Spasticity Scale, Timed 25-ft Walk, and Grooved Pegboard Test
Disability progressionWalking and mobilitySpasticity
Other measures (2)
Tolerability of study drug as determined by the Brief Symptom Inventory, Subjective Ratings of High and Sedation-Revised, and UKU Side Effect Rating Scale
SafetyEffect of study drug on global functioning and quality of life as indicated by the Multiple Sclerosis Quality of Life Inventory
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 and over
Inclusion Criteria: * Clinically definite or probable, laboratory-supported MS * Complaints of spasticity and at least moderate increase in tone as evidenced by a score of >= 2 on the Modified Ashworth Scale at either the elbow, hip, or knee * If on disease-modifying therapy ("ABC"), have been on a stable dose for at least six months * Fluent in English * If not cannabis-naive, must refrain from smoking cannabis for two weeks prior to screening (confirmed by urinalysis) * If on either lioresal (Baclofen) or tizanadine (Zanaflex), have been on a stable dose for at least three months * >=18 years of age Exclusion Criteria: * Axis I psychiatric disorder especially depression or significant neurological disease other than MS as determined by the PI * Recent history of active substance abuse defined as daily use for at least 14 days within the past month * Drug use restrictions, eg, subjects on probation or parole, employment involving high risk to themselves and/or the public (airline pilot, bus driver, etc.) * Any unstable medical health problem * Any known pulmonary disorders, including tuberculosis, asthma, or COPD * Pregnant or nursing * Require benzodiazepines to control spasticity * Require high doses of analgesic medications on a daily basis
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether or not smoked marijuana improves spasticity in patients with multiple sclerosis.
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History
Started
Sept 2001
Finished
Mar 2005
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