Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
|ClinicalTrials.gov Identifier: NCT01649050|
Recruitment Status : Withdrawn
First Posted : July 25, 2012
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Muscle Spasticity Due to Multiple Sclerosis||Drug: BGG492 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Study to Assess the Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
BGG492 tablets administered orally
Placebo Comparator: Placebo
Matching placebo administered orally
- Change in spasticity NRS score from baseline to 5 weeks [ Time Frame: 5 weeks ]The spasticity Numeric Rating Scale is a 0 to 10 patient reported scale of spasticity severity, with 0 being no spasticity and 10 being worst possible spasticity.
- PGIC score at 5 weeks [ Time Frame: 5 weeks ]The Patient Global Impression of Change is a patient reported one item mesaure of overall improvement in condition since the previous visit. The patient is asked to choose one of 7 sentences from very much improved to very much worse, that best describes his present condition.
- Change from baseline to 5 weeks in Ashworth spasticity score [ Time Frame: 5 weeks ]The Ashworth spasticity score is a physician assessed rating of spasticity using a five point score from 0 to 4 for each muscle group tested.
- Safety and tolerability [ Time Frame: average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit ]Number of patients with adverse events (AE).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649050
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|