Clinical trial NCT02065349: A Study Into Pain Relief Given by ASP8477 for Peripheral Neuropathic Pain (Either Post-herpetic Neuralgia or Painful Diabetic Peripheral Neuropathy) and Its Safety
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Herpetic Neuralgia (PHN)
Neuropathic Pain
Painful Diabetic Peripheral Neuropathy (PDPN)
Keywords: peripheral neuropathy
PHN
pain
PDPN
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in mean of 24-hour average pain intensity, Numeric pain rating scale (NPRS)
timeFrame: Baseline of the double-blind randomized withdrawal period to the last 3 days of double-blind randomized withdrawal period
Secondary outcomes:
measure: Time to treatment failure
timeFrame: Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
measure: Responder rate to ASP8477 in the Single-Blind Period
timeFrame: 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
measure: Patient Global Impression of Change (PGIC) score
timeFrame: From the baseline of the single-blind period to End of Treatment Visit (Day 49 or upon early discontinuation)
measure: Safety assessed by TEAE and SAE, laboratory tests, vital signs, C-SSRS, PWC and MWC scores, Bond-Lader score
timeFrame: From Screening to End of Study Visit (13 weeks)
measure: Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6
timeFrame: Day 14
Other outcomes:
Locations:
city: Chocen
country: Czechia
facility: Site: CZ42003
city: Litomysl
country: Czechia
facility: Site: CZ42004
city: Olomouc
country: Czechia
facility: Site: CZ42011
city: Praha 2
country: Czechia
facility: Site: CZ42014
city: Rychnov nad Kneznou
country: Czechia
facility: Site: CZ42001
city: Slezska Ostrava
country: Czechia
facility: Site: CZ42002
city: Koeln
country: Germany
facility: Site: DE49003
city: Neuss
country: Germany
facility: Site: DE49005
city: Bialystok
country: Poland
facility: Site: PL48003
city: Poznan
country: Poland
facility: Site: PL48004
city: Poznan
country: Poland
facility: Site: PL48001
city: Torun
country: Poland
facility: Site: PL48002
city: Warszawa
country: Poland
facility: Site: PL48005
city: Glasgow
country: United Kingdom
facility: Site: GB44001
state: Scotland
city: Ipswich
country: United Kingdom
facility: Site: GB44003
city: London
country: United Kingdom
facility: Site: GB44006
city: Manchester
country: United Kingdom
facility: Site: GB44002
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Medical Monitor
role: STUDY_DIRECTOR
References: