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

NCT02372578 | Terminated Phase 2 DMC

• 1 other identifier: 3662-CL-0049
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 37

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).

Conditions

Painful Diabetic Peripheral Neuropathy (PDPN)

Keywords

Painful diabetic peripheral neuropathy (PDPN); ASP3662

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (3)

ASP3662

EXPERIMENTAL

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; Drug: ASP3662 placebo; Drug: pregabalin placebo

pregabalin

ACTIVE COMPARATOR

pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.

Drug: pregabalin; Drug: ASP3662 placebo

Placebo

PLACEBO COMPARATOR

ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.

Drug: ASP3662 placebo; Drug: pregabalin placebo

Interventions

ASP3662 DRUG

oral

ASP3662

pregabalin DRUG

oral

pregabalin

ASP3662 placebo DRUG

oral

ASP3662; Placebo; pregabalin

pregabalin placebo DRUG

oral

ASP3662; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a BMI ≤ 40.
• Subject has all of the following:
• Established diagnosis of diabetes (Type I or II) with painful diabetic peripheral neuropathy and glycosylated hemoglobin (HgbA1c) ≤ 9.5% at Screening or Randomization.
• Stable diabetic drug regimen for at least 3 months prior to Screening.
• At least a 1 year history of PDPN.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (37)

Site US10001

Anniston, Alabama, 36207, United States

Location

Site US10039

Phoenix, Arizona, 85023, United States

Location

Site US10054

Fresno, California, 93720, United States

Location

Site US10020

Lomita, California, 90717, United States

Location

Site US10047

Santa Monica, California, 90404, United States

Location

Site US10017

Tustin, California, 92780, United States

Location

Site US10055

Walnut Creek, California, 94598, United States

Location

Site US10053

Fairfield, Connecticut, 06824, United States

Location

Site US10005

Boynton Beach, Florida, 33436, United States

Location

Site US10023

Bradenton, Florida, 34205, United States

Location

Site US10018

Clearwater, Florida, 33765, United States

Location

Site US10019

DeLand, Florida, 32720, United States

Location

Site US10004

Homestead, Florida, 33030, United States

Location

Site US10042

Jacksonville, Florida, 32256, United States

Location

Site US10007

Jupiter, Florida, 33458, United States

Location

Site US10041

Miami Lakes, Florida, 33014, United States

Location

Site US10046

Orlando, Florida, 32806, United States

Location

Site US10008

Ormond Beach, Florida, 32174, United States

Location

Site US10003

Oviedo, Florida, 32765, United States

Location

Site US10049

The Villages, Florida, 32162, United States

Location

Site US10009

Aurora, Illinois, 60506, United States

Location

Site US10036

Chicago, Illinois, 60624, United States

Location

Site US10025

Evansville, Indiana, 47714, United States

Location

Site US10064

Metairie, Louisiana, 70006, United States

Location

Site US10051

Boston, Massachusetts, 02115, United States

Location

Site US10026

New Bedford, Massachusetts, 02740-2133, United States

Location

Site US10063

Quincy, Massachusetts, 02169, United States

Location

Site US10043

Hazelwood, Missouri, 63042, United States

Location

Site US10013

Kettering, Ohio, 45429, United States

Location

Site US10014

Duncansville, Pennsylvania, 16635, United States

Location

Site US10015

Greer, South Carolina, 29651, United States

Location

Site US10034

Austin, Texas, 78731, United States

Location

Site US10040

Houston, Texas, 77030, United States

Location

Site US10032

San Antonio, Texas, 78218, United States

Location

Site US10031

San Antonio, Texas, 78228, United States

Location

Site US10033

Salt Lake City, Utah, 84107, United States

Location

Site US10045

Renton, Washington, 98057, United States

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

ASP3662; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2015
• First Posted: February 26, 2015
• Study Start: May 27, 2015
• Primary Completion: May 20, 2016
• Study Completion: May 20, 2016
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

US (37)