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

• Change in spasticity NRS score from baseline to 5 weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: Yes ]
  Number of patients with adverse events (AE).

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

• Drug: BGG492
• Drug: Placebo

• Experimental: BGG492
  BGG492 tablets administered orally
  Intervention: Drug: BGG492
• Placebo Comparator: Placebo
  Matching placebo administered orally
  Intervention: Drug: Placebo

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.