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

Phase 2

Terminated

Conditions: Painful Diabetic Peripheral Neuropathy (PDPN)

Interventions: Drug: pregabalin
Drug: ASP3662 placebo
Drug: ASP3662
Drug: pregabalin placebo

Registration Number: NCT02372578

Lead Sponsor: Astellas Pharma Global Development, Inc.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 115

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP3662	pregabalin placebo	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.
pregabalin	pregabalin	pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.
Placebo	ASP3662 placebo	ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.
Placebo	pregabalin placebo	ASP3662 placebo QD and pregabalin placebo TID for Weeks 1 - 7.
pregabalin	ASP3662 placebo	pregabalin TID and ASP3662 placebo QD for Weeks 1 - 7.
ASP3662	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.
ASP3662	ASP3662 placebo	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (37): Site US10001
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Anniston, Alabama, United States
Site US10039
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Phoenix, Arizona, United States
Site US10054
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Fresno, California, United States
Site US10020
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Lomita, California, United States
Site US10047
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Santa Monica, California, United States
Site US10017
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Tustin, California, United States
Site US10055
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Walnut Creek, California, United States
Site US10053
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Fairfield, Connecticut, United States
Site US10005
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Boynton Beach, Florida, United States
Site US10023
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Bradenton, Florida, United States
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Site US10001
🇺🇸Anniston, Alabama, United States