Peripheral Neuropathic Pain MedDRA version: 17.1 Level: PT Classification code 10036376 Term: Post herpetic neuralgia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.1 Level: LLT Classification code 10012683 Term: Diabetic peripheral neuropathy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Code: ASP8477
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not available
Current Sponsor code: ASP8477
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Astellas Pharma Europe B.V. (APEB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable). 2. Subject is a male or female subject, = 18 years of age, at Screening. 3. Subject has neuropathic pain resulting from PDPN or PHN per the investigator judgment. 4. Subject taking chronic pain medications (with the exception of opioids and cannabinoids, which are not allowed) must be on a stable regimen for = 1 month before Screening. This stable regimen cannot include PRN (occasional or as-needed) analgesia or PRN non-medication therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. Subject has significant pain (moderate or above) of an etiology other than PDPN or PHN (e.g., compression-related neuropathies [e.g., spinal stenosis, fibromyalgia or arthritis]), that may interfere with assessment of PDPN-, or PHN-related pain. 2. Subject has a documented history of an adverse reaction (hives, rash, etc.) or a clinically significant intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) or excipients of NSAIDs or ASP8477 medication. 3. Subject has a history of drug or alcohol abuse within 2 years prior to Screening., and/or will not agree to limit alcohol consumption to socially acceptable levels during the study 4. Subject is currently using protocol specified prohibited medications or non-medication therapies; including Over The Counter (OTC) products (refer to Concomitant Medication Restrictions or Requirements Section IV or Section 5.1.3 for details). A list of prohibited medications is provided in Appendix 12.1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess analgesic efficacy of ASP8477 relative to placebo in subjects with peripheral neuropathic pain as determined by the change in the average daily pain intensity in responders.;Secondary Objective: Key Secondary Objective - To assess analgesic efficacy of ASP8477 relative to placebo in subjects with peripheral neuropathic pain, as determined by the time to efficacy failure in responders. Other Secondary Objectives - To assess additional measures of efficacy of ASP8477. - To assess safety and tolerability of ASP8477 in responders and non-responders during the Single-Blind Period, and relative to placebo during the Double-Blind Randomized Withdrawal Period. - To assess pharmacokinetics of ASP8477 in responders and non-responders.;Primary end point(s): Change in mean of 24-hour average pain intensity, NPRS, from baseline of the Double-Blind Randomized Withdrawal Period to the last 3 days of the Double-Blind Randomized Withdrawal period in the responder population (= 30% decrease in mean average daily pain intensity at baseline of the Double-Blind Randomized Withdrawal Period versus baseline of the Single-Blind Period).;Timepoint(s) of evaluation of this end point: From baseline of the Double-Blind Randomized Withdrawal Period to the last 3 days of the Double-Blind Randomized Withdrawal Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy endpoint: - Time to treatment failure, defined as time from randomization to the first of 3 consecutive days in which mean 24-hour pain intensity was = 4, with at least a 30% increase in pain intensity relative to baseline of the Double-Blind Randomized Withdrawal Period in the responder population. Other secondary efficacy endpoints: - Responder rate to ASP8477 in the Single-Blind Period, defined as = 30% reduction in pain intensity from average of last three days NPRS score in placebo run-in to the average of the NPRS score of the final three days in the Single-Blind Period - Patient Global Impression of Change (PGIC) for overall patient status at the EOT/ED Visit for all subjects. Pharmacokinetic endpoints: - Individual pre- and post-dose plasma concentrations of ASP8477;Timepoint(s) of evaluation of this end point: -From randomization to the first of 3 consecutive days in which mean 24-hour pain intensity was = 4 -From baseline of the Single-Blind Period to the baseline of the Double-Blind Period -At EOT/ED visit | — |
Countries
Czech Republic, Germany, United Kingdom
Contacts
Public ContactService Desk
Astellas Pharma Europe B.V.
Outcome results
None listed