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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002783-27 | EudraCT Number |
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To evaluate efficacy and safety of BGG492 versus placebo on moderate to severe spasticity due to multiple sclerosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGG492 | Experimental | BGG492 tablets administered orally |
|
| Placebo | Placebo Comparator | Matching placebo administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGG492 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Safety and tolerability |
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Key Inclusion Criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| C000591013 | selurampanel |
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|
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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |