Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
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|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Recruitment Status : Withdrawn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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01649050
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|