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NCT00682929

Cannabis for Spasticity in Multiple Sclerosis

Terminated Phase 1, PHASE2 Results posted Last updated 18 May 2018
What this trial tests

Phase 1, PHASE2 trial testing Inhaled Cannabis in Multiple Sclerosis in 41 participants. Terminated before completion.

Timeline
14 April 2004
Primary endpoint
17 August 2011
17 August 2011

Quick facts

Lead sponsorUniversity of California, Davis
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment41
Start date14 April 2004
Primary completion17 August 2011
Estimated completion17 August 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Davis

Who can join

21 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. Th

GroupValue95% CI
1) Inhaled Cannabis0.0018± 0.0071
2) Oral THC-0.0121± 0.0183
3) Placebo0.0007± 0.0064
Change From Week 0 to Week 3 in Modified Ashworth Score (MAS) Secondary · Week 0, Week 3

The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.

GroupValue95% CI
1) Inhaled Cannabis-0.333± 1.0328
2) Oral THC0± 0.8944
3) Placebo-0.4545± 1.0357
Change From Week 0 to Week 7 in Modified Ashworth Score Secondary · Week 0, Week 7

The Modified Ashworth scale measures resistance during passive soft-tissue stretching. Spasticity is graded on a scale of 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). The highest score (flexion or extension), for the lower extremities only, was used for each subject. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result indicates a decrease in spasticity and correlates to a better outcome.

GroupValue95% CI
1) Inhaled Cannabis1.1429± 0.6901
2) Oral THC-0.3750± 0.5175
3) Placebo-0.2500± 0.7538
Change From Week 0 to Week 3 in Ambulation Index (AI) Score Secondary · Week 0, Week 3

The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 3 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates

GroupValue95% CI
1) Inhaled Cannabis0± 0.6325
2) Oral THC0± 0.6667
3) Placebo0.1818± 0.4045
Change From Week 0 to Week 7 in Ambulation Index (AI) Score Secondary · Week 0, Week 7

The AI is a 9-point rating scale used to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. Scores range from 0 (asymptomatic, fully active) to 9 (restricted to wheelchair, unable to transfer self independently). Lower scores represent a better outcome for MS patients. For this study, the AI score was based on the results of the 25 Foot Walk test, also performed at the study visit. The change was calculated by taking the Week 7 score and subtracting the Week 0 score. A negative result for this outcome indicates an improvement in ambulation and correlates

GroupValue95% CI
1) Inhaled Cannabis0.1429± 0.3780
2) Oral THC0.4444± 0.5270
3) Placebo0.3333± 0.6513
Change From Week 0 to Week 3 in 25 Foot Walk Time Secondary · Week 0, Week 3

The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.

GroupValue95% CI
1) Inhaled Cannabis-0.0100± 1.6300
2) Oral THC-3.3714± 4.5605
3) Placebo0.1400± 1.9998
Change From Week 0 to Week 7 in 25 Foot Walk Time Secondary · Week 0, Week 7

The Timed 25 Foot Walk is a quantitative measure of lower extremity function. The patient is instructed to walk on a marked 25-foot course, as quickly and as safely as possible. The patient is allowed to use his/her typical walking aid, if applicable. The task is completed twice and the average time of the two trials was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in walking ability and correlates to a better outcome.

GroupValue95% CI
1) Inhaled Cannabis-2.6000± 5.6240
2) Oral THC3.3667± 9.7660
3) Placebo2.2773± 6.3507
Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension Primary · Week 0, Week 3

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. Th

GroupValue95% CI
1) Inhaled Cannabis0.0004± 0.0136
2) Oral THC-0.0310± 0.0780
3) Placebo0.0105± 0.0208
Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion Primary · Week 0, Week 7

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. Th

GroupValue95% CI
1) Inhaled Cannabis-0.0013± 0.0405
2) Oral THC-0.0015± 0.0235
3) Placebo0.0043± 0.0161
LIDO Machine Score - Rate of Torque Increase, Extension Primary · Week 0, Week 7

A modified servo-controlled torque motor system (Lido WorkSet II) was designed for this study to analyze the resistance to passive movement of the knee. It determines the amount of torque required to move the knee joint (without voluntary resistance) at high velocities (up to 200 degrees per second) and at slow velocities (as low as 10 degrees per second). The slow displacement torque is a measure of the passive resistance to movement (from the connective tissue and the non-contracting muscle) and the rapid displacement torques are the sum of the passive and active (involuntary) resistance. Th

GroupValue95% CI
1) Inhaled Cannabis-0.0122± 0.0049
2) Oral THC-0.0019± 0.0256
3) Placebo0.0186± 0.0240
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time Secondary · Week 0, Week 3

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 3 time and subtracting the Week 0 time. A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

GroupValue95% CI
1) Inhaled Cannabis-0.8929± 3.2680
2) Oral THC-1.5244± 7.8972
3) Placebo1.4450± 8.7548
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time Secondary · Week 0, Week 7

The 9 hold peg test is a quantitative measure of upper extremity (arm and hand function). Patients are instructed to fill an 9 hole peg board with 1 peg at a time and then immediately remove the pegs, 1 at a time. The dominant hand is tested twice and the average time was used for this outcome measure. The change was calculated by taking the Week 7 time and subtracting the Week 0 time. A negative result indicates an improvement in arm and hand function and correlates with a better outcome.

GroupValue95% CI
1) Inhaled Cannabis5.6714± 20.9260
2) Oral THC1.4756± 11.3974
3) Placebo-0.4991± 7.2244

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event information was collected beginning with the initial dosing visit and continuing through the final follow up visit. Collection period was over approximately 4 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

1) Inhaled Cannabis
Serious: 3/13 (23%)
Deaths: 0/13
2) Oral THC
Serious: 1/14 (7%)
Deaths: 0/14
3) Placebo
Serious: 0/14 (0%)
Deaths: 0/14

Serious adverse events (4 terms)

ReactionSystem1) Inhaled Cannabis2) Oral THC3) Placebo
hypotensionCardiac disorders
dehydration due to gastroenteritisGastrointestinal disorders
planned insertion of baclofen pumpSurgical and medical procedures
hypersexual thoughtsPsychiatric disorders
Other adverse events (84 terms — click to expand)

ReactionSystem1) Inhaled Cannabis2) Oral THC3) Placebo
euphoriaPsychiatric disorders
lightheadednessCardiac disorders
depressionPsychiatric disorders
dry mouthGastrointestinal disorders
sense of relaxationPsychiatric disorders
nauseaGastrointestinal disorders
paresthesiaNervous system disorders
generalized weaknessNervous system disorders
drowsinessNervous system disorders
hip painMusculoskeletal and connective tissue disorders
dizzinessNervous system disorders
difficulty concentratingPsychiatric disorders
inappropriate laughterPsychiatric disorders
headacheNervous system disorders
paranoiaPsychiatric disorders
sore throatGastrointestinal disorders
imbalanceNervous system disorders
limb painNervous system disorders
upper respiratory infectionInfections and infestations
hypotensionCardiac disorders
insomniaNervous system disorders
urinary tract infectionInfections and infestations
facial flushingNervous system disorders
feeling of heavinessGeneral disorders
increased appetiteNervous system disorders
loquaciousPsychiatric disorders
anxietyPsychiatric disorders
sinusitisInfections and infestations
coughRespiratory, thoracic and mediastinal disorders
tinnitusEar and labyrinth disorders
Multiple Sclerosis relapseNervous system disorders
blurred visionEye disorders
diaphoresisNervous system disorders
chest painCardiac disorders
depersonalizationPsychiatric disorders
THC dependencePsychiatric disorders
gastroenteritisInfections and infestations
flu-like symptomsGeneral disorders
dry eyesEye disorders
palpitationsCardiac disorders

Most-reported serious reactions: hypotension, dehydration due to gastroenteritis, planned insertion of baclofen pump, hypersexual thoughts.

Data from ClinicalTrials.gov NCT00682929 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cannabis and cannabinoids for symptomatic treatment for people with multiple sclerosis.
    Filippini G, Minozzi S, Borrelli F, Cinquini M, et al · · 2022 · cited 41× · PMID 35510826 · DOI 10.1002/14651858.cd013444.pub2

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Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00682929.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing