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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Muscle Spasticity Due to Multiple Sclerosis
• Intervention / Treatment: Drug: Placebo; Drug: BGG492

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGG492; BGG492 tablets administered orally	Drug: BGG492
Placebo Comparator: Placebo; Matching placebo administered orally	Drug: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: July 6, 2012
• First Submitted That Met QC Criteria: July 20, 2012
• First Posted (Estimate): July 25, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Spasticity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Multiple Sclerosis; Sclerosis; Muscle Spasticity
• Other Study ID Numbers: CBGG492A2215; 2012-002783-27 (EudraCT Number)