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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01649050

Enrollment

Registered

2012-07-25

Start date

2016-10-31

Completion date

2018-03-31

Last updated

2017-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity Due to Multiple Sclerosis

Keywords

Spasticity, Multiple Sclerosis

Brief summary

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

Interventions

DRUGBGG492

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026