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

• Status: Withdrawn
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.