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



Status:Terminated
Conditions:Diabetic Neuropathy, Neurology, Pain
Therapuetic Areas:Endocrinology, Musculoskeletal, Neurology
Healthy:No
Age Range:18 - 75
Updated:3/28/2019
Start Date:May 27, 2015
End Date:May 20, 2016

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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).


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.
We found this trial at
37
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46 Joy Street
Boston, Massachusetts 02114
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Anniston, Alabama 36207
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Aurora, Illinois 60506
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Austin, Texas 78705
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Boynton Beach, Florida 33436
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Bradenton, Florida 34205
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Chicago, Illinois 60612
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70 South Missouri Avenue
Clearwater, Florida 33765
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Deland, Florida 32720
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Duncansville, Pennsylvania 16635
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Evansville, Indiana 47714
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Fairfield, Connecticut 06824
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Fresno, California 93720
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Greer, South Carolina 29651
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Hazelwood, Missouri 63042
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Homestead, Florida 33030
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Houston, Texas 77030
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Jacksonville, Florida 32256
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Jupiter, Florida 33458
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Kettering, Ohio 45429
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Lomita, California 90717
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Metairie, Louisiana 70006
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Miami Lakes, Florida 33104
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New Bedford, Massachusetts 02740
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Orlando, Florida 32806
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Ormond Beach, Florida 32174
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Oviedo, Florida 32765
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Phoenix, Arizona 85014
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Quincy, Massachusetts 02169
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Renton, Washington 98057
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Salt Lake City, Utah 84143
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Santa Monica, California 90404
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The Villages, Florida 32162
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Tustin, California 92780
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