Clinical trial NCT00682929: Cannabis for Spasticity in Multiple Sclerosis
Official title: Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis
Keywords: cannabis
marijuana
Multiple Sclerosis
spasticity
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2008-05-23
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

The effects of these agents analyzed at 3 weeks and 7 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria
* Moderate or severe spasticity
* Age 21 or older
* Must live close to the Sacramento, CA area

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
* Pre-existing dementia, mania, depression or schizophrenia or other poorly controlled psychiatric illness
* 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 four weeks
* Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled psychiatric illness
* Exacerbation of MS within 30 days prior to screening visit
* Current use of cyclophosphamide, mitoxantrone, 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
* For females of child bearing potential, inability to comply with adequate contraception

Primary outcomes:
measure: Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion
timeFrame: Week 0, Week 7
measure: LIDO Machine Score - Rate of Torque Increase, Extension
timeFrame: Week 0, Week 7
Secondary outcomes:
measure: Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Modified Ashworth Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Ambulation Index (AI) Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Ambulation Index (AI) Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in 25 Foot Walk Time
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in 25 Foot Walk Time
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Vision
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Vision
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Brainstem
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Brainstem
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Pyramidal
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Pyramidal
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Cerebellar
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Cerebellar
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Sensory
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Sensory
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Functional System Score - Cerebral
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Functional System Score - Cerebral
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score
timeFrame: Week 0, Week 7
measure: Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score
timeFrame: Week 0, Week 3
measure: Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score
timeFrame: Week 0, Week 7
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Michelle Apperson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: