A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

NCT01345045 | Completed Phase 2

• 2 other identifiers: M11-8912010-024359-99
• Study Type: interventional
• Target: 193
• Locations: 5 countries
• Sites: 35

Brief Summary

People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.

Conditions

Diabetic Neuropathic Pain

Keywords

Diabetic Asymmetric Polyneuropathy; Symmetric Diabetic Proximal Motor Neuropathy; Diabetic Mononeuropathy Simplex,; Diabetic Autonomic Neuropathy,; Diabetic Amyotrophy; Mononeuropathy; Diabetic Neuropathy; Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Polyneuropathy; Painful; Diabetic Mononeuropathy; Neuralgia

Outcome Measures

Primary Outcomes (1)

• A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary

  Daily questions asked on a hand held diary

  Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)

Secondary Outcomes (3)

• Patient's Global Impression of Change

  Week 2, Week 4 and Week 6 (End of Study)

• Brief Pain Inventory (BPI) (short form) including Severity and Interference

  At each visit up to Week 6 (end of Study)

• Neuropathic Pain Symptom Inventory (NPSI)

  Baseline, Week 2, Week 4 and Week 6 (end of Study)

Study Arms (3)

ABT-639

EXPERIMENTAL

ABT-639 twice daily for 6 weeks

Drug: ABT-639

pregabalin

ACTIVE COMPARATOR

pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Placebo twice daily for 6 weeks

Drug: Placebo

Interventions

ABT-639 DRUG

ABT-639 Twice Daily for six weeks.

ABT-639

pregabalin DRUG

pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.

Also known as: Lyrica

pregabalin

Placebo DRUG

Placebo twice daily for 6 weeks.

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 is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
• Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

You may not qualify if:

• Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
• A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
• Subject has clinically significant abnormalities in clinical laboratory tests.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (35)

Site Reference ID/Investigator# 51807

Little Rock, Arkansas, 72204, United States

Location

Site Reference ID/Investigator# 51946

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 51468

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 52744

Walnut Creek, California, 94598, United States

Location

Site Reference ID/Investigator# 51079

Clearwater, Florida, 33765, United States

Location

Site Reference ID/Investigator# 51076

Hialeah, Florida, 33012, United States

Location

Site Reference ID/Investigator# 51945

Hollywood, Florida, 33021, United States

Location

Site Reference ID/Investigator# 51077

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 51078

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 51804

Brockton, Massachusetts, 02301, United States

Location

Site Reference ID/Investigator# 51263

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 51268

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 51302

Omaha, Nebraska, 68131, United States

Location

Site Reference ID/Investigator# 51271

Flushing, New York, 11365, United States

Location

Site Reference ID/Investigator# 52743

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 51806

Altoona, Pennsylvania, 16602, United States

Location

Site Reference ID/Investigator# 51265

Tipton, Pennsylvania, 16684, United States

Location

Site Reference ID/Investigator# 51548

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 51269

Renton, Washington, 98055, United States

Location

Site Reference ID/Investigator# 51425

Hradec Králové, 500 03, Czechia

Location

Site Reference ID/Investigator# 51426

Mor Ostrava, 702 00, Czechia

Location

Site Reference ID/Investigator# 51424

Olomouc, 77900, Czechia

Location

Site Reference ID/Investigator# 51428

Prague, 100 00, Czechia

Location

Site Reference ID/Investigator# 51423

Prague, 160 00, Czechia

Location

Site Reference ID/Investigator# 51427

Zlín, 760 01, Czechia

Location

Site Reference ID/Investigator# 51924

Le Creusot, 71200, France

Location

Site Reference ID/Investigator# 51925

Vénissieux, 69200, France

Location

Site Reference ID/Investigator# 51503

Berlin, 10115, Germany

Location

Site Reference ID/Investigator# 51642

Düsseldorf, 40225, Germany

Location

Site Reference ID/Investigator# 51502

Mainz, D - 55116, Germany

Location

Site Reference ID/Investigator# 52346

Münster, 48145, Germany

Location

Site Reference ID/Investigator# 51505

Guadalajara, Jal., C.P. 44130, Mexico

Location

Site Reference ID/Investigator# 51504

Mexico City, C.P. 11650, Mexico

Location

Site Reference ID/Investigator# 51522

Monterrey, N.L., C.P. 64000, Mexico

Location

Site Reference ID/Investigator# 51506

Monterrey, N.L., C.P. 64460, Mexico

Location

Related Publications (1)

• Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-2020. doi: 10.1097/j.pain.0000000000000263.

  PMID: 26067585 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies; Mononeuropathies; Pain; Neuralgia

Interventions

4-chloro-2-fluoro-N-(2-fluorophenyl)-5-(hexahydropyrrolo(1,2-a)pyrazin-2(1H)-ylcarbonyl)benzenesulfonamide; Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rachel Duan, MD

  AbbVie

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

FR (2); CZ (6); DE (4); ME (4); US (19)