Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis

Study Overview
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Brief Summary
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To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis

Official Title
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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

Conditions
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Muscle Spasticity Due to Multiple Sclerosis

Intervention / Treatment
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* Drug: BGG492
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of multiple sclerosis (MS) of any type. MS diagnosis at least 6 months prior to screening. Stable MS with no relapse within 3 months prior to screening. Treated or untreated spasticity due to MS for at least 3 months prior to screening, not wholly relieved with antispasticity medications. Key exclusion criteria: Patients with symptoms of spasticity not due to MS. Patients taking three or more different anti-spasticity medications. Acute MS exacerbation requiring treatment within 3 months of the Screening Visit. Initiation of, or the discontinuation of interferon beta or any other disease modifying therapy for MS within 3 months of the Screening Visit. Use of baclofen pump at any time. Wheelchair or bed-bound patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGG492<br>BGG492 tablets administered orally | Drug: BGG492<br> <br> |
| Placebo Comparator: Placebo<br>Matching placebo administered orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spasticity NRS score from baseline to 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. | 5 weeks | 
| PGIC score at 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. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 5 weeks in Ashworth spasticity score | 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. | 5 weeks | 
| Safety and tolerability | Number of patients with adverse events (AE). | average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, Multiple Sclerosis