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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01649050
Recruitment Status : Withdrawn
First Posted : July 25, 2012
Last Update Posted : April 20, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

July 6, 2012
July 25, 2012
April 20, 2017
October 2016
March 2018   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01649050 on Archive Site
  • 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).
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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Identifier (NCT Number) in Medline.
March 2018
March 2018   (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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany,   Russian Federation
2012-002783-27 ( EudraCT Number )
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
August 2014

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