A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety

NCT02065349 | Completed Phase 2

• 2 other identifiers: 8477-CL-00202013-002521-27
• Study Type: interventional
• Target: 132
• Locations: 4 countries
• Sites: 17

Brief Summary

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.

Conditions

Post-Herpetic Neuralgia (PHN); Neuropathic Pain; Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

peripheral neuropathy; PHN; pain; PDPN

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Time to treatment failure

  Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure

• 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

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

oral

Drug: Placebo

ASP8477

ACTIVE COMPARATOR

oral

Drug: ASP8477

Interventions

ASP8477 DRUG

oral

ASP8477

Placebo DRUG

oral

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PDPN subject must have:
• Established diagnosis of diabetes (type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HbA1c) ≤ 11% at Screening.
• Stable glycemic control (HbA1c ≤ 11%) achieved by a drug regimen for at least 3 months prior to Screening.
• At least a 1-year history of DPN pain.
• Diabetic distal symmetrical polyneuropathy symptoms (including pain) stable for at least the last 3 months prior to Screening based on PI judgment and subject-reported medical history.
• PHN subject must have pain present ≥ 6 months after healing of the herpes zoster rash.

You may not qualify if:

• Subject has significant pain of an etiology other than PDPN or PHN, or clearly non differentiated pain, or plantar fasciitis, heel spurs, tibial neuropathy, Morton's neuroma, bunions, metatarsalgia, arthritis in feet, ischemic pain, neurological disorders unrelated to diabetic neuropathy, skin condition in area of neuropathy that could alter sensation, malignancy, or current orthostatic hypotension, hypo or hypertension, syncope or clinically significant ECG, clinical intolerance to Non-steroidal anti-inflammatory drugs (NSAIDs) or ASP8477, depression, psychosis or psychiatric or neurological illness, BMI of over 35, renal impairment or failure, alcohol (ETOH) or drug abuse, GI complaints.
• Previous investigational therapy within 28 days or 5 half lives

Sponsors & Collaborators

• Astellas Pharma Europe B.V.: lead

Study Sites (17)

Site: CZ42003

Choceň, 561 01, Czechia

Location

Site: CZ42004

Litomyšl, 517 14, Czechia

Location

Site: CZ42011

Olomouc, 77900, Czechia

Location

Site: CZ42014

Prague, 12000, Czechia

Location

Site: CZ42001

Rychnov nad Kněžnou, 516 01, Czechia

Location

Site: CZ42002

Slezská Ostrava, 710 00, Czechia

Location

Site: DE49003

Cologne, 50937, Germany

Location

Site: DE49005

Neuss, 41460, Germany

Location

Site: PL48003

Bialystok, 15-950, Poland

Location

Site: PL48004

Poznan, 60-773, Poland

Location

Site: PL48001

Poznan, 61-655, Poland

Location

Site: PL48002

Torun, 87-100, Poland

Location

Site: PL48005

Warsaw, 00-465, Poland

Location

Site: GB44001

Glasgow, Scotland, G12OYN, United Kingdom

Location

Site: GB44003

Ipswich, IP45PD, United Kingdom

Location

Site: GB44006

London, SE17EH, United Kingdom

Location

Site: GB44002

Manchester, M320UT, United Kingdom

Location

Related Links

• Link to results on the Astellas Clinical Study Results website.

MeSH Terms

Conditions

Neuralgia, Postherpetic; Neuralgia; Peripheral Nervous System Diseases; Pain

Interventions

ASP8477

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Monitor

  Astellas Pharma Europe B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 19, 2014
• Study Start: February 24, 2014
• Primary Completion: February 13, 2015
• Study Completion: February 13, 2015
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

DE (2); CZ (6); PL (5); GB (4)