Text Size

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

This study is not yet open for participant recruitment.
Verified July 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01649050
First received: July 6, 2012
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in spasticity NRS score from baseline to 5 weeks [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events (AE).


Estimated Enrollment: 145
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649050

Contacts
Contact: Novartis Pharmaceuticals +41 61 324 1111

Locations
Germany
Novartis Investigative Site
Berlin, Germany, D-10117
Russian Federation
Novartis Investigative Site Not yet recruiting
Moscow, Russian Federation, 129110
Novartis Investigative Site Not yet recruiting
Moscow, Russian Federation, 125367
Novartis Investigative Site Not yet recruiting
Moscow, Russian Federation, 127018
Novartis Investigative Site Not yet recruiting
St. Petersburg, Russian Federation, 197110
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01649050     History of Changes
Other Study ID Numbers: CBGG492A2215, 2012-002783-27
Study First Received: July 6, 2012
Last Updated: July 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Poland: Ministry of Health

Keywords provided by Novartis:
Spasticity
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013