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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT02065349
First received: February 13, 2014
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Neuropathic Pain
Painful Diabetic Peripheral Neuropathy (PDPN)
Post-Herpetic Neuralgia (PHN)
Drug: ASP8477
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    TEAE=Treatment Emergent Adverse Events, SAE = Serious Adverse Event, C-SSRS = Columbia Suicide Severity Rating Scale, PWC = Physician Withdrawal Checklist, MWC = Marijuana Withdrawal Checklist

  • Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
oral
Active Comparator: ASP8477 Drug: ASP8477
oral

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065349

Contacts
Contact: Global Clinical Science, APGD +31 (0)71 5455 050 contact@nl.astellas.com

Locations
Czech Republic
Site: CZ42003 Recruiting
Chocen, Czech Republic, 561 01
Site: CZ42004 Recruiting
Litomysl, Czech Republic, 517 14
Site: CZ42011 Recruiting
Olomouc, Czech Republic, 77900
Site: CZ42001 Recruiting
Rychnov nad Kneznou, Czech Republic, 516 01
Site: CZ42002 Recruiting
Slezska Ostrava, Czech Republic, 710 00
Germany
Site: DE49003 Recruiting
Koeln, Germany, 50937
Site: DE49005 Recruiting
Neuss, Germany, 41460
Poland
Site: PL48003 Recruiting
Bialystok, Poland, 15-950
Site: PL48001 Recruiting
Poznan, Poland, 61-655
Site: PL48004 Recruiting
Poznan, Poland, 60-773
Site: PL48002 Recruiting
Torun, Poland, 87-100
Site: PL48005 Recruiting
Warszawa, Poland, 00-465
United Kingdom
Site: GB44001 Recruiting
Glasgow, Scotland, United Kingdom, G12OYN
Site: GB44003 Recruiting
Ipswich, United Kingdom, IP45PD
Site: GB44006 Recruiting
London, United Kingdom, SE17EH
Site: GB44002 Recruiting
Manchester, United Kingdom, M320UT
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Director: Medical Monitor Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier: NCT02065349     History of Changes
Other Study ID Numbers: 8477-CL-0020, 2013-002521-27
Study First Received: February 13, 2014
Last Updated: October 7, 2014
Health Authority: Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
peripheral neuropathy
PDPN
PHN
pain

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neuralgia
Pain
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014