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
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- Change in spasticity NRS score from baseline to 5 weeks
Study Overview
Brief Summary
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
BGG492
BGG492 tablets administered orally
Intervention: BGG492 (Drug)
Placebo
Matching placebo administered orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in spasticity NRS score from baseline to 5 weeks
Time Frame: 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
Time Frame: 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 Outcomes
- Change from baseline to 5 weeks in Ashworth spasticity score(5 weeks)
- Safety and tolerability(average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit)