Cannabis for Spasticity in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00260741
• Date of registration: 30/11/2005
• Prospective Registration: No
• Primary sponsor: Center for Medicinal Cannabis Research
• Public title: Cannabis for Spasticity in Multiple Sclerosis
• Scientific title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
• Date of first enrolment: March 2003
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00260741
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Mark Agius, M.D.
• Affiliation: University of California, Davis

Key inclusion & exclusion criteria

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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Smoked Cannabis

Primary Outcome(s)

Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.

Secondary Outcome(s)

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.

Secondary ID(s)

C00-DA-112

200311404-4

Source(s) of Monetary Support

Please refer to primary and secondary sponsors