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

Neuropathic Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065349
• Other study ID #: 8477-CL-0020
• Secondary ID: 2013-002521-27
• Status: Completed
• Phase: Phase 2
• First received: February 13, 2014
• Last updated: November 6, 2017
• Start date: February 24, 2014
• Est. completion date: February 13, 2015

Study information

• Verified date: November 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 13, 2015
• Est. primary completion date: February 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Pain
• Painful Diabetic Peripheral Neuropathy (PDPN)
• Peripheral Nervous System Diseases
• Post-Herpetic Neuralgia (PHN)

Intervention

Drug:
• ASP8477
oral
• Placebo
oral

Locations

Country	Name	City	State
Czechia	Site: CZ42003	Chocen
Czechia	Site: CZ42004	Litomysl
Czechia	Site: CZ42011	Olomouc
Czechia	Site: CZ42014	Praha 2
Czechia	Site: CZ42001	Rychnov nad Kneznou
Czechia	Site: CZ42002	Slezska Ostrava
Germany	Site: DE49003	Koeln
Germany	Site: DE49005	Neuss
Poland	Site: PL48003	Bialystok
Poland	Site: PL48001	Poznan
Poland	Site: PL48004	Poznan
Poland	Site: PL48002	Torun
Poland	Site: PL48005	Warszawa
United Kingdom	Site: GB44001	Glasgow	Scotland
United Kingdom	Site: GB44003	Ipswich
United Kingdom	Site: GB44006	London
United Kingdom	Site: GB44002	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Czechia,  Germany,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
Secondary	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
Secondary	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)
Secondary	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	From Screening to End of Study Visit (13 weeks)
Secondary	Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6		Day 14

External Links

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