Stopped earlyPhase 1Phase 2MS (type not specified)NCT00260741

What it found

Stopped early

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

    1. Started

      Mar 2003

    2. Finished

      Jan 2006

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