A Phase 3 Dose Response Study to Assess the Safety and Efficacy of Nabiximols Oromucosal Spray (Sativex) in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis.

NCT01868048 Phase 3 WITHDRAWN

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex compared with placebo in relieving symptoms of spasticity due to multiple sclerosis.

Details

Lead sponsor	GW Research Ltd
Phase	Phase 3
Status	WITHDRAWN

Conditions

• Spasticity
• Multiple Sclerosis

Interventions

• Sativex
• Placebo

Primary outcomes

• Physician Global Impression of Change (PGIC) questionnaire — This is completed by the physician at each visit whilst using the study medication.
• Change in mean Modified Ashworth Scale score from baseline to the end of treatment period. — The Modified Ashworth Scale will be performed at each visit of the study
  All 20 muscle groups were assessed for spasticity (using a 0-4 scale): 0= no increase in muscle tone to 4=considerable increase in muscle tone, passive movement is difficult. The score for all 20 muscle groups were added to give a total score out of 80. A decrease in score indicates an improvement in condition.