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

Phase 2

Withdrawn

• Conditions: Muscle Spasticity Due to Multiple Sclerosis
• Interventions: Drug: BGG492; Drug: Placebo

• Registration Number: NCT01649050
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-20
• Study First Posted: 2012-07-25
• Status Verified: 2014-08
• Study Start: 2016-10
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGG492	BGG492	BGG492 tablets administered orally
Placebo	Placebo	Matching placebo administered orally

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).