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

Phase 2WithdrawnNCT01649050

Novartis Pharmaceuticals

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Muscle Spasticity Due to Multiple Sclerosis

Interventions

BGG492DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5 weeks

Secondary Outcomes

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.

Time frame: 5 weeks

Safety and tolerability

Number of patients with adverse events (AE).

Time frame: average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit

Data from ClinicalTrials.gov

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