Clinical trial NCT02372578: Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
Official title: A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)
Keywords: Painful diabetic peripheral neuropathy (PDPN)
ASP3662
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo.

The analgesic effect is evaluated by measuring percent responders, change in daily worst pain score, change in average daily pain score, Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC).


Eligibility criteria: Inclusion Criteria:

* Subject has a BMI ≤ 40.
* Subject has all of the following:

  1. Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.
  2. Stable diabetic drug regimen for at least 3 months prior to Screening.
  3. At least a 1 year history of PDPN.
  4. Diagnosis of PDPN to be confirmed by a score of ≥ 3 on the Michigan Neuropathy Screening Instrument (MNSI) at Screening.
* Subject has pain intensity score(s) ≥ 4 or ≤ 9 on an 11-point numeric pain rating scale (NPRS) at Screening Visit and prior to Randomization.
* Subject agrees to complete pain diaries and is complaint with the daily pain recording prior to Randomization as defined by the completion of a minimum of 5 of 7 daily pain ratings, 3 of which are required in the last 4 days.
* Subject's anti-diabetic regimen is anticipated to be stable throughout the study.
* Subject must be willing to washout of all medications currently being taken for his/her PDPN (chronic and occasional/as needed) and remain off of those pain medications while participating in the study.

Exclusion Criteria:

* Subject has received prior treatment with pregabalin for PDPN and was considered unresponsive or intolerant.
* Subject has tried and failed 3 or more drugs to treat PDPN within the past 3 years. Drugs must have been administered at therapeutic doses and have been administered for an adequate period of time.
* Subject has a known hypersensitivity to ASP3662, pregabalin, gabapentin or acetaminophen, or their formulation components.
* Subject has significant pain (moderate or above) due to causes other than PDPN.
* Subject has a history of painful peripheral neuropathy due to a cause other than diabetes.
* Subject has any lower extremity amputation
* Subject has a current or previous foot ulcer within the past 3 months as described by medical history and/or medical examination.
* Subject has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years.
* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine at Screening.
* Subject has creatinine clearance \< 60 mL/min (estimated from serum creatinine, body weight, age, and sex using the Cockcroft and Gault equation) at Screening.
* Subject tests positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody at Screening or has a known history of a positive test for human immunodeficiency virus (HIV) infection.
* Subject has a positive drug screen for alcohol or drugs of abuse at Screening and/or Randomization. Subjects who are on low doses of benzodiazepines for sleep with a legitimate prescription will be allowed into the study. In addition, subjects with a positive drug screen at Randomization will be excluded.
* Subject is currently using protocol specified non-permitted medications including OTC products and is unable or does not choose to discontinue them.
* Subject has planned an elective surgery during planned study participation.

Primary outcomes:
measure: Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS
timeFrame: Baseline to Week 6/ End of Treatment (EOT)
Secondary outcomes:
measure: Percentage of Responders in mean 24-hour average pain intensity score
timeFrame: Baseline to Week 6/ EOT
measure: Change from Baseline in mean of 24-hour average pain intensity score
timeFrame: Baseline to Weeks 1, 2, 3, 4, 5 and 6
measure: Change from Baseline in mean daily worst pain score
timeFrame: Baseline to Week 6/ EOT
measure: Change from Baseline in mean daily average pain score
timeFrame: Baseline to Week 6/ EOT
measure: Patient Global Impression Change (PGIC)
timeFrame: Week 6/ EOT
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Week 6/ EOT
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Site US10001
state: Alabama
city: Phoenix
country: United States
facility: Site US10039
state: Arizona
city: Fresno
country: United States
facility: Site US10054
state: California
city: Lomita
country: United States
facility: Site US10020
state: California
city: Santa Monica
country: United States
facility: Site US10047
state: California
city: Tustin
country: United States
facility: Site US10017
state: California
city: Walnut Creek
country: United States
facility: Site US10055
state: California
city: Fairfield
country: United States
facility: Site US10053
state: Connecticut
city: Boynton Beach
country: United States
facility: Site US10005
state: Florida
city: Bradenton
country: United States
facility: Site US10023
state: Florida
city: Clearwater
country: United States
facility: Site US10018
state: Florida
city: DeLand
country: United States
facility: Site US10019
state: Florida
city: Homestead
country: United States
facility: Site US10004
state: Florida
city: Jacksonville
country: United States
facility: Site US10042
state: Florida
city: Jupiter
country: United States
facility: Site US10007
state: Florida
city: Miami Lakes
country: United States
facility: Site US10041
state: Florida
city: Orlando
country: United States
facility: Site US10046
state: Florida
city: Ormond Beach
country: United States
facility: Site US10008
state: Florida
city: Oviedo
country: United States
facility: Site US10003
state: Florida
city: The Villages
country: United States
facility: Site US10049
state: Florida
city: Aurora
country: United States
facility: Site US10009
state: Illinois
city: Chicago
country: United States
facility: Site US10036
state: Illinois
city: Evansville
country: United States
facility: Site US10025
state: Indiana
city: Metairie
country: United States
facility: Site US10064
state: Louisiana
city: Boston
country: United States
facility: Site US10051
state: Massachusetts
city: New Bedford
country: United States
facility: Site US10026
state: Massachusetts
city: Quincy
country: United States
facility: Site US10063
state: Massachusetts
city: Hazelwood
country: United States
facility: Site US10043
state: Missouri
city: Kettering
country: United States
facility: Site US10013
state: Ohio
city: Duncansville
country: United States
facility: Site US10014
state: Pennsylvania
city: Greer
country: United States
facility: Site US10015
state: South Carolina
city: Austin
country: United States
facility: Site US10034
state: Texas
city: Houston
country: United States
facility: Site US10040
state: Texas
city: San Antonio
country: United States
facility: Site US10032
state: Texas
city: San Antonio
country: United States
facility: Site US10031
state: Texas
city: Salt Lake City
country: United States
facility: Site US10033
state: Utah
city: Renton
country: United States
facility: Site US10045
state: Washington
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Senior Medical Director
role: STUDY_DIRECTOR
References: