Cannabis for Spasticity in Multiple Sclerosis - Full Text View

Sponsor:	Center for Medicinal Cannabis Research
Information provided by:	Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:	NCT00260741

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Smoked Cannabis	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Marijuana Multiple Sclerosis

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	60
Study Start Date:	March 2003
Study Completion Date:	January 2006

Detailed Description:

The treatment of MS is far from satisfactory. For acute attacks, high dose corticosteroids seem to reduce the duration of attacks and to reduce the likelihood of future attacks. Immunomodulatory agents, available in this disease over the last decade, reduce the frequency of severe attacks by about one third. The remainder of the treatments are symptomatic, aimed at reducing the disability already present.

Recent research into the CB1 and CB2 cannabinoid receptor systems suggest that cannabis may have the potential for affecting both the pathogenic mechanisms and the symptoms of MS. In light of the autoimmune hypothesis of the etiology of MS, THC could directly alter immune function in a manner that might reduce (or increase) the primary pathology of the disease.

Comparisons: Three treatment arms will be compared: 1) inhaled cannabis and oral placebo, 2) inhaled placebo and oral THC, 3) inhaled placebo and oral placebo, with the effects of these agents analyzed at thirty and sixty days.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260741

Locations

United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817

Sponsors and Collaborators

Center for Medicinal Cannabis Research

Investigators

Principal Investigator:

Mark Agius, M.D.

University of California, Davis

More Information

Additional Information:

Center for Medicinal Cannabis Research This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	C00-DA-112, 200311404-4
Study First Received:	November 30, 2005
Last Updated:	April 3, 2007
ClinicalTrials.gov Identifier:	NCT00260741 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:

cannabis
marijuana
Multiple Sclerosis
Spasticity

Additional relevant MeSH terms:

Neuromuscular Manifestations
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Sclerosis
Signs and Symptoms
Muscle Spasticity

Pathologic Processes
Multiple Sclerosis
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neurologic Manifestations
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 04, 2010