Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy

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

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).

Study Overview

• Status: Terminated
• Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)
• Intervention / Treatment: Drug: ASP3662; Drug: ASP3662 placebo; Drug: pregabalin placebo; Drug: pregabalin

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Site US10001
  • Arizona
    • Phoenix, Arizona, United States, 85023
      • Site US10039
  • California
    • Fresno, California, United States, 93720
      • Site US10054
    • Lomita, California, United States, 90717
      • Site US10020
    • Santa Monica, California, United States, 90404
      • Site US10047
    • Tustin, California, United States, 92780
      • Site US10017
    • Walnut Creek, California, United States, 94598
      • Site US10055
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Site US10053
  • Florida
    • Boynton Beach, Florida, United States, 33436
      • Site US10005
    • Bradenton, Florida, United States, 34205
      • Site US10023
    • Clearwater, Florida, United States, 33765
      • Site US10018
    • DeLand, Florida, United States, 32720
      • Site US10019
    • Homestead, Florida, United States, 33030
      • Site US10004
    • Jacksonville, Florida, United States, 32256
      • Site US10042
    • Jupiter, Florida, United States, 33458
      • Site US10007
    • Miami Lakes, Florida, United States, 33014
      • Site US10041
    • Orlando, Florida, United States, 32806
      • Site US10046
    • Ormond Beach, Florida, United States, 32174
      • Site US10008
    • Oviedo, Florida, United States, 32765
      • Site US10003
    • The Villages, Florida, United States, 32162
      • Site US10049
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Site US10009
    • Chicago, Illinois, United States, 60624
      • Site US10036
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Site US10025
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Site US10064
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Site US10051
    • New Bedford, Massachusetts, United States, 02740-2133
      • Site US10026
    • Quincy, Massachusetts, United States, 02169
      • Site US10063
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • Site US10043
  • Ohio
    • Kettering, Ohio, United States, 45429
      • Site US10013
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Site US10014
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Site US10015
  • Texas
    • Austin, Texas, United States, 78731
      • Site US10034
    • Houston, Texas, United States, 77030
      • Site US10040
    • San Antonio, Texas, United States, 78218
      • Site US10032
    • San Antonio, Texas, United States, 78228
      • Site US10031
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Site US10033
  • Washington
    • Renton, Washington, United States, 98057
      • Site US10045

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ASP3662; ASP3662 once daily (QD) and pregabalin placebo 3 times daily (TID) for Weeks 1 - 6. ASP3662 placebo QD and pregabalin placebo TID for Week 7.	Drug: ASP3662; oral; Drug: ASP3662 placebo; oral; Drug: pregabalin placebo; oral
Active Comparator: pregabalin; pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.	Drug: ASP3662 placebo; oral; Drug: pregabalin; oral
Placebo Comparator: Placebo; ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.	Drug: ASP3662 placebo; oral; Drug: pregabalin placebo; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in mean 24-hour average pain intensity as reported on the NPRS	Numerical Pain Rating Scale (NPRS)	Baseline to Week 6/ End of Treatment (EOT)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Responders in mean 24-hour average pain intensity score	Baseline to Week 6/ EOT
Change from Baseline in mean of 24-hour average pain intensity score	Baseline to Weeks 1, 2, 3, 4, 5 and 6
Change from Baseline in mean daily worst pain score	Baseline to Week 6/ EOT
Change from Baseline in mean daily average pain score	Baseline to Week 6/ EOT
Patient Global Impression Change (PGIC)	Week 6/ EOT
Clinical Global Impression of Change (CGIC)	Week 6/ EOT

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2015
• Primary Completion (Actual): May 20, 2016
• Study Completion (Actual): May 20, 2016

Study Registration Dates

• First Submitted: February 21, 2015
• First Submitted That Met QC Criteria: February 21, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: ASP3662; Painful diabetic peripheral neuropathy (PDPN)
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain; Diabetic Neuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: 3662-CL-0049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Studies conducted with product indications or formulations that remain in development are assessed after study completion to determine if Individual Participant Data can be shared. The plan to share Individual Participant Data is based on the status of product approval or termination of the compound, in addition to other study-specific criteria described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."