Cannabis for Spasticity in Multiple Sclerosis

Stopped earlyPhase 1Phase 2MS (type not specified)NCT00682929

What it found

Stopped early

The trial ended early for another reason (see below).

Reason given: Unable to complete subject recruitment

What was tested

Treatment tested

Inhaled Cannabis
Dronabinol
Cannabinoid CB1 receptor agonist

Placebo or sham

Oral Placebo
Inhaled placebo

Results by group

Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion

Week 0, Week 3

Group	Value	Interval	Number analysed
1) Inhaled Cannabis	0.0018 degrees/second	0.0071 (Standard Deviation)	7
2) Oral THC	-0.0121 degrees/second	0.0183 (Standard Deviation)	9
3) Placebo	0.0007 degrees/second	0.0064 (Standard Deviation)	9

1) Inhaled Cannabis

2) Oral THC

3) Placebo

Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension

Week 0, Week 3

Group	Value	Interval	Number analysed
1) Inhaled Cannabis	0.0004 degrees/second	0.0136 (Standard Deviation)	7
2) Oral THC	-0.0310 degrees/second	0.078 (Standard Deviation)	9
3) Placebo	0.0105 degrees/second	0.0208 (Standard Deviation)	9

1) Inhaled Cannabis

2) Oral THC

3) Placebo

Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion

Week 0, Week 7

Group	Value	Interval	Number analysed
1) Inhaled Cannabis	-0.0013 degrees/second	0.0405 (Standard Deviation)	7
2) Oral THC	-0.0015 degrees/second	0.0235 (Standard Deviation)	8
3) Placebo	0.0043 degrees/second	0.0161 (Standard Deviation)	11

1) Inhaled Cannabis

2) Oral THC

3) Placebo

LIDO Machine Score - Rate of Torque Increase, Extension

Week 0, Week 7

Group	Value	Interval	Number analysed
1) Inhaled Cannabis	-0.0122 degrees/second	0.0049 (Standard Deviation)	7
2) Oral THC	-0.0019 degrees/second	0.0256 (Standard Deviation)	8
3) Placebo	0.0186 degrees/second	0.024 (Standard Deviation)	11

1) Inhaled Cannabis

2) Oral THC

3) Placebo

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events
1) Inhaled Cannabis	13	3 (23.1%)
2) Oral THC	14	1 (7.1%)
3) Placebo	14	0 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion
Week 0, Week 3
Spasticity
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension
Week 0, Week 3
Spasticity
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion
Week 0, Week 7
Spasticity
LIDO Machine Score - Rate of Torque Increase, Extension
Week 0, Week 7
Spasticity

Other measures (50)

Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)
Week 0, Week 3
Spasticity
Change From Week 0 to Week 7 in Modified Ashworth Score
Week 0, Week 7
Spasticity
Change From Week 0 to Week 3 in Ambulation Index (AI) Score
Week 0, Week 3
Walking and mobility
Change From Week 0 to Week 7 in Ambulation Index (AI) Score
Week 0, Week 7
Walking and mobility
Change From Week 0 to Week 3 in 25 Foot Walk Time
Week 0, Week 3
Disability progressionWalking and mobility
Change From Week 0 to Week 7 in 25 Foot Walk Time
Week 0, Week 7
Disability progressionWalking and mobility
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time
Week 0, Week 3
Disability progressionArm and hand function
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time
Week 0, Week 7
Disability progressionArm and hand function
Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time
Week 0, Week 3
Disability progressionArm and hand function
Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time
Week 0, Week 7
Disability progressionArm and hand function

Who could take part

MS (type not specified) · 21 and over

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

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.

Papers

Loading reviews and guidelines…

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History

Started
Apr 2004
Main results due
Aug 2011
Finished
Aug 2011
Results posted
May 2018

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