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

Novartis

Status and phase: Withdrawn; Phase 2

Conditions: Muscle Spasticity Due to Multiple Sclerosis

Treatments: Drug: Placebo; Drug: BGG492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01649050

2012-002783-27 (EudraCT Number)

CBGG492A2215

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

BGG492

Experimental group

Description:

BGG492 tablets administered orally

Treatment:

Drug: BGG492

Placebo

Placebo Comparator group

Description:

Matching placebo administered orally

Treatment:

Drug: Placebo