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

November 6, 2017 updated by: Astellas Pharma Europe B.V.

A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Chocen, Czechia, 561 01
        • Site: CZ42003
      • Litomysl, Czechia, 517 14
        • Site: CZ42004
      • Olomouc, Czechia, 77900
        • Site: CZ42011
      • Praha 2, Czechia, 12000
        • Site: CZ42014
      • Rychnov nad Kneznou, Czechia, 516 01
        • Site: CZ42001
      • Slezska Ostrava, Czechia, 710 00
        • Site: CZ42002
  • Germany
      • Koeln, Germany, 50937
        • Site: DE49003
      • Neuss, Germany, 41460
        • Site: DE49005
  • Poland
      • Bialystok, Poland, 15-950
        • Site: PL48003
      • Poznan, Poland, 60-773
        • Site: PL48004
      • Poznan, Poland, 61-655
        • Site: PL48001
      • Torun, Poland, 87-100
        • Site: PL48002
      • Warszawa, Poland, 00-465
        • Site: PL48005
  • United Kingdom
      • Ipswich, United Kingdom, IP45PD
        • Site: GB44003
      • London, United Kingdom, SE17EH
        • Site: GB44006
      • Manchester, United Kingdom, M320UT
        • Site: GB44002
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12OYN
        • Site: GB44001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
oral
Drug: Placebo
oral
Active Comparator: ASP8477
oral
Drug: ASP8477
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
Time Frame: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period
Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to treatment failure
Time Frame: Date of randomization to first 3 consecutive days of double-blind period with an observed 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
Responder rate to ASP8477 in the Single-Blind Period
Time Frame: 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
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
Time Frame: From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation)
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
Time Frame: From Screening to End of Study Visit (13 weeks)
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
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2014

Primary Completion (Actual)

February 13, 2015

Study Completion (Actual)

February 13, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 6, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8477-CL-0020
  • 2013-002521-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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