Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabix… (NCT01868048) | Clinical Trial Compass
WithdrawnPhase 3
Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis.
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Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to give written informed consent.
* The subject is at least 18 years of age or older.
* Diagnosed with any disease sub-type of multiple sclerosis of at least six months duration.
* Spasticity due to multiple sclerosis of at least six months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
* Subject must be receiving at least one of the following anti-spasticity therapies to be eligible: Baclofen, Tizanidine, Clonazepam, Diazepam, Dantrolene.
* Subject is willing to maintain anti-spasticity medication at a stable dose for the duration of the study and should be stable for 30 days prior to screening.
* If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
Exclusion Criteria:
* Has previously used Nabiximols or Sativex.
* The subject is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study.
* Any history or immediate family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
* In the opinion of the Investigator, any known or suspected history of a s…
What they're measuring
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Physician Global Impression of Change (PGIC) questionnaire
Timeframe: This is completed by the physician at each visit whilst using the study medication.
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Change in mean Modified Ashworth Scale score from baseline to the end of treatment period.
Timeframe: The Modified Ashworth Scale will be performed at each visit of the study