Muscle Spasticity Due to Multiple Sclerosis Clinical Trial
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
| Verified date | August 2014 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2018 |
| Est. primary completion date | March 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in spasticity NRS score from baseline to 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. | 5 weeks | |
| Primary | PGIC score at 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. | 5 weeks | |
| Secondary | Change from baseline to 5 weeks in Ashworth spasticity score | 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. | 5 weeks | |
| Secondary | Safety and tolerability | Number of patients with adverse events (AE). | average of 70 days, maximum from day -19 to day 52, i.e. from first baseline up to study completion visit |