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.
The study will consist of a Screening Period, Single-Blind Treatment Period, Double-Blind Randomized Withdrawal Period and Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
oral
oral
Site: CZ42003
Choceň, Czechia
Site: CZ42004
Litomyšl, Czechia
Site: CZ42011
Olomouc, Czechia
Site: CZ42014
Prague, Czechia
Site: CZ42001
Rychnov nad Kněžnou, Czechia
Site: CZ42002
Slezská Ostrava, Czechia
Site: DE49003
Cologne, Germany
Site: DE49005
Neuss, Germany
Site: PL48003
Bialystok, Poland
Site: PL48004
Poznan, Poland
...and 7 more locations
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
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
Time frame: Date of randomization to first 3 consecutive days of double-blind period with an observed treatment failure
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
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)
Composite of pharmacokinetics of ASP8477 concentration: Trough concentration (Ctrough), observed maximum concentration (Cmax), Area under the curve (AUC)0-6
Time frame: Day 14
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