Cannabis for Spasticity in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: Discontinued due to non-enrollment.
This trial finished 20 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
Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.
Spasticity
Other measures (1)
Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.
Disability progressionSpasticityQuality of life (reported by participants)
Who could take part
MS (type not specified) · 21 and over
Inclusion Criteria: * Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria * Primary or secondary disease course * Moderate or severe spasticity * Age 21 or older Exclusion Criteria: * Preexisting pulmonary conditions, including poorly controlled asthma, chronic bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders * Preexisting cardiac conditions, including ischemic heart disease, congestive heart failure, and other significant cardiac disorders * Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative or hypnotic medications during the duration of the study * Past history of abuse of recreational drugs, including marijuana and alcohol in the last 12 months * History of or currently meets DSM-IV criteria for dependence on cannabis * Use of cannabis, marijuana, or THC in the last two weeks * Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness * Exacerbation of MS within 30 days prior to screenin visit * Current use of cyclophosphamide, mitoxanthrone, or cladribine * Arthritis, bony and soft tissue disorders interfering with spasticity measures * Inability to provide informed consent * Recent cannabis use of more than twice per week one month prior to study entry
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 learn if the use of inhaled cannabis (marijuana) and oral cannabinoid (dronabinol, Marinol or THC, which is an active ingredient of marijuana) is safe and effective in reducing the symptoms of spasticity and tremor in patients with secondary-progressive or primary progressive multiple sclerosis.
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History
Started
Mar 2003
Finished
Jan 2006
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