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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01649050
First received: July 6, 2012
Last updated: August 21, 2014
Last verified: August 2014
  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:


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).


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649050

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: August 21, 2014
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:
Muscle Spasticity
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014