CompletedPhase 1Phase 2MS (type not specified)NCT00248378

What it found

No result 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

    Safety
  • Effect 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

    1. Started

      Sept 2001

    2. Finished

      Mar 2005

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