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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02065349
First Posted: February 19, 2014
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
  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
Post-Herpetic Neuralgia (PHN) Neuropathic Pain Painful Diabetic Peripheral Neuropathy (PDPN) Drug: ASP8477 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ( Astellas Pharma Europe B.V. ):

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 ]

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 ]
    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 ]
  • 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) ]
  • 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

  • Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6 [ Time Frame: Day 14 ]

Enrollment: 132
Actual Study Start Date: February 24, 2014
Study Completion Date: February 13, 2015
Primary Completion Date: February 13, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
oral
Drug: Placebo
oral
Active Comparator: ASP8477
oral
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065349


Locations
Czechia
Site: CZ42003
Chocen, Czechia, 561 01
Site: CZ42004
Litomysl, Czechia, 517 14
Site: CZ42011
Olomouc, Czechia, 77900
Site: CZ42014
Praha 2, Czechia, 12000
Site: CZ42001
Rychnov nad Kneznou, Czechia, 516 01
Site: CZ42002
Slezska Ostrava, Czechia, 710 00
Germany
Site: DE49003
Koeln, Germany, 50937
Site: DE49005
Neuss, Germany, 41460
Poland
Site: PL48003
Bialystok, Poland, 15-950
Site: PL48004
Poznan, Poland, 60-773
Site: PL48001
Poznan, Poland, 61-655
Site: PL48002
Torun, Poland, 87-100
Site: PL48005
Warszawa, Poland, 00-465
United Kingdom
Site: GB44001
Glasgow, Scotland, United Kingdom, G12OYN
Site: GB44003
Ipswich, United Kingdom, IP45PD
Site: GB44006
London, United Kingdom, SE17EH
Site: GB44002
Manchester, United Kingdom, M320UT
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Director: Medical Monitor Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02065349     History of Changes
Other Study ID Numbers: 8477-CL-0020
2013-002521-27 ( EudraCT Number )
First Submitted: February 13, 2014
First Posted: February 19, 2014
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
peripheral neuropathy
PHN
pain
PDPN

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