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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: July 6, 2012
Last updated: April 19, 2017
Last verified: August 2014
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis

Condition Intervention Phase
Muscle Spasticity Due to Multiple Sclerosis Drug: BGG492 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change from baseline to 5 weeks in Ashworth spasticity score [ Time Frame: 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 [ Time Frame: 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).

Enrollment: 0
Study Start Date: October 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGG492
BGG492 tablets administered orally
Drug: BGG492
Placebo Comparator: Placebo
Matching placebo administered orally
Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01649050

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01649050     History of Changes
Other Study ID Numbers: CBGG492A2215
2012-002783-27 ( EudraCT Number )
Study First Received: July 6, 2012
Last Updated: April 19, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple Sclerosis

Additional relevant MeSH terms:
Muscle Spasticity
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms processed this record on September 20, 2017