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

July 6, 2012
July 20, 2012
November 2012
September 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01649050 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Efficacy of 5 Weeks of Treatment With BGG492 in Patients With Spasticity Due to Multiple Sclerosis
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Muscle Spasticity Due to Multiple Sclerosis
  • Drug: BGG492
  • Drug: Placebo
  • Experimental: BGG492
    BGG492 tablets administered orally
    Intervention: Drug: BGG492
  • Placebo Comparator: Placebo
    Matching placebo administered orally
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
145
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Novartis Pharmaceuticals +41 61 324 1111
Germany,   Russian Federation
 
NCT01649050
CBGG492A2215, 2012-002783-27
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP