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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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The study is a randomized, double blind, placebo-controlled, parallel-group comparison (two dose levels of EMA401 versus a placebo group), of safety and efficacy in patients with postherpetic neuralgia.
Screening Period (Up to Four Weeks) to confirm eligibility for the study which will be determined by Screening tests, physical examination/medical history and fulfillment of eligibility criteria including assessment of pain.
Study Period (14 Weeks) Approximately 360 eligible male and female patients will receive double-blind treatment for 14 weeks. Patients will be randomized in a 1:1:1 ratio to treatment with EMA401 100 mg BID, 300 mg BID or placebo.
Patients will attend the study site at the end of the Baseline visit and end of Weeks 1, 3, 5, 7, 9, 11, 13, and 14 for on-study assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMA401 200 mg | Experimental | 2 X 50 mg capsules BID |
|
| EMA401 600 mg | Experimental | 2 X 150 mg capsules BID |
|
| Placebo | Placebo Comparator | Placebo to match 2 capsules BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMA401 200 mg | Drug |
| ||
| EMA401 600 mg |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the efficacy of two dose levels of EMA401 compared to placebo in patients with postherpetic neuralgia (PHN), as assessed by the change in the weekly mean of the 24 hour average pain score using an 11-point Numerical Rating Scale (NRS) | Baseline to approximately Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of EMA401 compared to placebo on the Brief Pain Inventory-Short Form (BPI-SF) interference total score | Baseline to approximately Week 14 | |
| To evaluate the effect of EMA401 compared to placebo on the weekly mean of the 24 hour worst NRS pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000595242 | EMA400 |
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|
| Placebo | Drug |
|
| Baseline to approximately Week 14 |
| To evaluate the effect of EMA401 compared to placebo on the Patient Global Impression of Change (PGIC) | Baseline to approximately Week 14 |
| To evaluate the effect of EMA401 compared to placebo on the BPI-SF average pain | Baseline to approximately Week 14 |
| To determine the proportion of EMA401 patients achieving a ≥ 30% and a ≥ 50% reduction in weekly mean pain of the 24 hour average score (NRS) compared to placebo (i.e., responder rates) | Baseline to approximately Week 14 |
| To evaluate the effect of EMA401 compared to placebo on the Insomnia Severity Index (ISI) | Baseline to approximately Week 14 |
| To evaluate the safety and tolerability of EMA401 in patients with PHN as measured by adverse events, vital signs, and laboratory results | Baseline to approximately Week 14 |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |