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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002521-27 | EudraCT Number |
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The purpose of this study is to assess the painkilling efficacy of ASP8477 relative to mock (placebo) in patients that have been diagnosed with painful diabetic peripheral neuropathy or postherpetic neuralgia determined by the change in the average daily pain intensity in patients that initially respond favorably to treatment with ASP8477.
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | oral |
|
| ASP8477 | Active Comparator | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP8477 | Drug | oral |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS) | Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | Treatment failure is defined as mean 24 hour pain intensity was equal or more than 4 with at least a 30% increase in pain intensity relative to baseline of the double-blind randomized withdrawal period | Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure |
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Inclusion Criteria:
PDPN subject must have:
PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site: CZ42003 | Choceň | 561 01 | Czechia | |||
| Site: CZ42004 |
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| Label | URL |
|---|---|
| Link to results on the Astellas Clinical Study Results website. | View source |
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| Drug |
oral |
|
| Responder rate to ASP8477 in the Single-Blind Period |
| Baseline of the single-blind period (last 3 days of the placebo run-in period) to baseline of the double-blind period (last 3 days of the single-blind period |
| Patient Global Impression of Change (PGIC) score | From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation) |
| Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score | TEAE=Treatment Emergent Adverse Events, SAE = Serious Adverse Event, C-SSRS = Columbia Suicide Severity Rating Scale, PWC = Physician Withdrawal Checklist, MWC = Marijuana Withdrawal Checklist | From Screening to End of Study Visit (13 weeks) |
| Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6 | Day 14 |
| Litomyšl |
| 517 14 |
| Czechia |
| Site: CZ42011 | Olomouc | 77900 | Czechia |
| Site: CZ42014 | Prague | 12000 | Czechia |
| Site: CZ42001 | Rychnov nad Kněžnou | 516 01 | Czechia |
| Site: CZ42002 | Slezská Ostrava | 710 00 | Czechia |
| Site: DE49003 | Cologne | 50937 | Germany |
| Site: DE49005 | Neuss | 41460 | Germany |
| Site: PL48003 | Bialystok | 15-950 | Poland |
| Site: PL48004 | Poznan | 60-773 | Poland |
| Site: PL48001 | Poznan | 61-655 | Poland |
| Site: PL48002 | Torun | 87-100 | Poland |
| Site: PL48005 | Warsaw | 00-465 | Poland |
| Site: GB44001 | Glasgow | Scotland | G12OYN | United Kingdom |
| Site: GB44003 | Ipswich | IP45PD | United Kingdom |
| Site: GB44006 | London | SE17EH | United Kingdom |
| Site: GB44002 | Manchester | M320UT | United Kingdom |
| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000632156 | ASP8477 |
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