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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-03-31

Brief Summary

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

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Detailed Description

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Conditions

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Muscle Spasticity Due to Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BGG492

BGG492 tablets administered orally

Group Type EXPERIMENTAL

BGG492

Intervention Type DRUG

Placebo

Matching placebo administered orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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BGG492

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No