A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study.

Time frame

Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)

Measure

MEAN · Spasms per day

Reporting status

POSTED

The subjects' baseline spasm frequency was the mean of the last seven days scores (Week 4) of Phase A treatment. The variable for analysis was the change in mean spasm frequency from baseline to the end of treatment (last 7 days of Week 17 Phase B).

Time frame

Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)

Measure

MEAN · Points on scale

Reporting status

POSTED

The sleep disruption NRS score was recorded by subjects via a daily call to the interactive voice response system at bedtime. Subjects were asked "On a scale of '0 to 10' please indicate how you your spasticity disrupted your sleep last night" with the anchors: 0 = 'did not disrupt sleep' and 10 = 'completely disrupted (unable to sleep at all)'.

Time frame

Baseline (End of Week 4) - End of treatment (End of Week 17)

Measure

MEAN · Score on scale

Reporting status

POSTED

All 20 muscle groups were assessed for spasticity (using a 1-5 scale): 1= no increase in muscle tone to 5= passive movement is difficult and affected part is rigid in flexion or extension. The score for all 20 muscle groups were added to give a total score out of 100; minimum score was 20. A decrease in score indicates an improvement in condition.

Time frame

Baseline (End of Week 4) - End of treatment (End of Week 17)

Measure

MEAN · Score on scale

Reporting status

POSTED

Arm - 3 movements were pinch grip, elbow flexion and shoulder abduction. Leg - 3 movements were ankle dorsiflexion, knee extension and hip flexion. The total arm and leg score was the addition of the score for the 3 arm movements and 3 leg movements, respectively. One point was then added to each limb score to give a maximum score of 100; minimum was 1 point. Where both arms (or both legs) were assessed, the average of the two limbs scores was used as the assessment score; otherwise the affected limb total score was used. An increase in score indicates an improvement in condition.

Population: For Arm subject numbers were 23 for Sativex and 22 for placebo. For Leg subject numbers were 91 for Sativex and 92 for placebo.

Time frame

Baseline (End of Week 4) - End of treatment (End of Week 17)

Measure

MEAN · Seconds

Reporting status

POSTED

Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk. A negative difference from baseline indicates an improvement walk time.

Population: Only those subjects for whom it was appropriate (i.e. ambulatory subjects) were timed how long it took to walk 10 metres. Walk time was only assessed for subjects who successfully completed the Timed 10 Metre Walk.

Time frame

End of Treatment (WeeK 17)

Measure

NUMBER · participants

Reporting status

POSTED

Time frame

End of treatment (Week 17)

Measure

NUMBER · participants

Reporting status

POSTED

Population: Sample sizes were reduced as not all subjects had a Carer to make this assessment.

Time frame

End of treatment (week 17)

Measure

NUMBER · participants

Reporting status

POSTED

Population: Sample sizes were reduced as not all subjects had a Carer to make this assessment.

Time frame

End of treatment (week 17)

Measure

NUMBER · participants

Reporting status

POSTED

Time frame

[Baseline (End of Week 4) - End of treatment (End of Week 17)

Measure

MEAN · score on scale

Reporting status

POSTED

The EQ-5D questionnaire provided two outcomes: 1. A weighted health state index visual analogue scale (VAS) 2. A self-rated health status VAS EQ-5D Health Status VAS Scale: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition. The weighted health state index used the same VAS as above but was calculated for each assessment without imputation to account for missing values i.e., if one or more individual items was missing then the whole index was missing.

Population: EQ-5D Health State Index Sativex n=117 and placebo n=111. EQ-5D Health Status VAS Sativex n=121 and placebo n=117.

Time frame

Baseline (End of week 4) - end of treatment (end of week 17)

Measure

MEAN · Score on scale

Reporting status

POSTED

This was a 21-question multiple choice self-report inventory. Subjects' responses to the 21 questions were assigned a score ranging from zero to three, indicating the severity of the symptom. The sum of all BDI-II question scores indicated the severity of depression; score range 0-63. An decrease in score indicates an improvement in condition.

Only those subjects who were deemed responders to Sativex from Phase A (i.e. at least a 20% reduction in mean 0-10 point numerical rating scale (NRS) spasticity score between screening and the end of the four week Phase A treatment) were eligible to enter Phase B of the study.