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)
Primary Purpose
Post-Herpetic Neuralgia (PHN), Neuropathic Pain, Painful Diabetic Peripheral Neuropathy (PDPN)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASP8477
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-Herpetic Neuralgia (PHN) focused on measuring peripheral neuropathy, PHN, pain, PDPN
Eligibility 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
Sites / Locations
- Site: CZ42003
- Site: CZ42004
- Site: CZ42011
- Site: CZ42014
- Site: CZ42001
- Site: CZ42002
- Site: DE49003
- Site: DE49005
- Site: PL48003
- Site: PL48004
- Site: PL48001
- Site: PL48002
- Site: PL48005
- Site: GB44001
- Site: GB44003
- Site: GB44006
- Site: GB44002
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
ASP8477
Arm Description
oral
oral
Outcomes
Primary Outcome Measures
Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
Secondary Outcome Measures
Time to 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
Patient Global Impression of Change (PGIC) score
Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score
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
Full Information
NCT ID
NCT02065349
First Posted
February 13, 2014
Last Updated
November 6, 2017
Sponsor
Astellas Pharma Europe B.V.
1. Study Identification
Unique Protocol Identification Number
NCT02065349
Brief Title
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety
Acronym
MOBILE
Official Title
A Phase 2a Enriched Enrollment Randomized Withdrawal Study to Assess Analgesic Efficacy and Safety of ASP8477 in Subjects With Peripheral Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 24, 2014 (Actual)
Primary Completion Date
February 13, 2015 (Actual)
Study Completion Date
February 13, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Herpetic Neuralgia (PHN), Neuropathic Pain, Painful Diabetic Peripheral Neuropathy (PDPN)
Keywords
peripheral neuropathy, PHN, pain, PDPN
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral
Arm Title
ASP8477
Arm Type
Active Comparator
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
ASP8477
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Time to treatment failure
Description
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
Time Frame
Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
Title
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
Title
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)
Title
Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score
Description
TEAE=Treatment Emergent Adverse Events, SAE = Serious Adverse Event, C-SSRS = Columbia Suicide Severity Rating Scale, PWC = Physician Withdrawal Checklist, MWC = Marijuana Withdrawal Checklist
Time Frame
From Screening to End of Study Visit (13 weeks)
Title
Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site: CZ42003
City
Chocen
ZIP/Postal Code
561 01
Country
Czechia
Facility Name
Site: CZ42004
City
Litomysl
ZIP/Postal Code
517 14
Country
Czechia
Facility Name
Site: CZ42011
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Facility Name
Site: CZ42014
City
Praha 2
ZIP/Postal Code
12000
Country
Czechia
Facility Name
Site: CZ42001
City
Rychnov nad Kneznou
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Site: CZ42002
City
Slezska Ostrava
ZIP/Postal Code
710 00
Country
Czechia
Facility Name
Site: DE49003
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Site: DE49005
City
Neuss
ZIP/Postal Code
41460
Country
Germany
Facility Name
Site: PL48003
City
Bialystok
ZIP/Postal Code
15-950
Country
Poland
Facility Name
Site: PL48004
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Site: PL48001
City
Poznan
ZIP/Postal Code
61-655
Country
Poland
Facility Name
Site: PL48002
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Site: PL48005
City
Warszawa
ZIP/Postal Code
00-465
Country
Poland
Facility Name
Site: GB44001
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12OYN
Country
United Kingdom
Facility Name
Site: GB44003
City
Ipswich
ZIP/Postal Code
IP45PD
Country
United Kingdom
Facility Name
Site: GB44006
City
London
ZIP/Postal Code
SE17EH
Country
United Kingdom
Facility Name
Site: GB44002
City
Manchester
ZIP/Postal Code
M320UT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=217
Description
Link to results on the Astellas Clinical Study Results website.
Learn more about this trial
A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety
We'll reach out to this number within 24 hrs