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, FlexionPrimary· 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
Group
Value
95% CI
1) Inhaled Cannabis
0.0018
± 0.0071
2) Oral THC
-0.0121
± 0.0183
3) Placebo
0.0007
± 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.
Group
Value
95% CI
1) Inhaled Cannabis
-0.333
± 1.0328
2) Oral THC
0
± 0.8944
3) Placebo
-0.4545
± 1.0357
Change From Week 0 to Week 7 in Modified Ashworth ScoreSecondary· 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.
Group
Value
95% CI
1) Inhaled Cannabis
1.1429
± 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) ScoreSecondary· 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
Group
Value
95% CI
1) Inhaled Cannabis
0
± 0.6325
2) Oral THC
0
± 0.6667
3) Placebo
0.1818
± 0.4045
Change From Week 0 to Week 7 in Ambulation Index (AI) ScoreSecondary· 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
Group
Value
95% CI
1) Inhaled Cannabis
0.1429
± 0.3780
2) Oral THC
0.4444
± 0.5270
3) Placebo
0.3333
± 0.6513
Change From Week 0 to Week 3 in 25 Foot Walk TimeSecondary· 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.
Group
Value
95% CI
1) Inhaled Cannabis
-0.0100
± 1.6300
2) Oral THC
-3.3714
± 4.5605
3) Placebo
0.1400
± 1.9998
Change From Week 0 to Week 7 in 25 Foot Walk TimeSecondary· 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.
Group
Value
95% CI
1) Inhaled Cannabis
-2.6000
± 5.6240
2) Oral THC
3.3667
± 9.7660
3) Placebo
2.2773
± 6.3507
Change From Week 0 to Week 3 in the Rate of Torque Increase, ExtensionPrimary· 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
Group
Value
95% CI
1) Inhaled Cannabis
0.0004
± 0.0136
2) Oral THC
-0.0310
± 0.0780
3) Placebo
0.0105
± 0.0208
Change From Week 0 to Week 7 in the Rate of Torque Increase, FlexionPrimary· 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
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
Group
Value
95% CI
1) Inhaled Cannabis
-0.0122
± 0.0049
2) Oral THC
-0.0019
± 0.0256
3) Placebo
0.0186
± 0.0240
Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) TimeSecondary· 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.
Group
Value
95% CI
1) Inhaled Cannabis
-0.8929
± 3.2680
2) Oral THC
-1.5244
± 7.8972
3) Placebo
1.4450
± 8.7548
Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) TimeSecondary· 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.
Group
Value
95% CI
1) Inhaled Cannabis
5.6714
± 20.9260
2) Oral THC
1.4756
± 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.
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):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of California, Davis
Last refreshed: 18 May 2018
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.