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

• BGG492 (Drug)
• Placebo (Drug)

Primary outcomes

• Change in spasticity NRS score from baseline to 5 weeks [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 [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.

Secondary outcomes

• Change from baseline to 5 weeks in Ashworth spasticity score [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 [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).

Sex: All, ages: 18 Years to 65 Years

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.

• Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals