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

NCT01649050 | Withdrawn Phase 2

• 2 other identifiers: CBGG492A22152012-002783-27
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Muscle Spasticity Due to Multiple Sclerosis

Keywords

Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

BGG492

EXPERIMENTAL

BGG492 tablets administered orally

Drug: BGG492

Placebo

PLACEBO COMPARATOR

Matching placebo administered orally

Drug: Placebo

Interventions

BGG492 DRUG

BGG492

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Interventions

selurampanel

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 25, 2012
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: April 20, 2017

Record last verified: 2014-08