Diabetic Peripheral Neuropathic Pain (DPNP)

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314222
• Other study ID #: CN169-001
• Secondary ID: 2010-023042-70
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2011
• Last updated: November 6, 2015
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: November 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

Description:

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.

• Score of =3 on Michigan Neuropathy Screening Instrument

• The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.

• Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).

• Male or female, 18-85 years of age.

Exclusion Criteria:

• History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).

• Other severe pain that may potentially confound pain assessment.

• Hemoglobin A1c > 9%

• Hemoglobin = 9 g/dL

• Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation = 50ml/min/1.73m2

• Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for <4 weeks prior to randomization. Patients who are on stable doses for = 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.

• Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• BMS-954561

• Pregabalin

• Placebo matching BMS-954561

• Placebo matching Pregabalin

Locations

Country	Name	City	State
France	Local Institution	Dijon Cedex
France	Local Institution	Nantes Cedex 1
France	Local Institution	Nice Cedex 1
United States	Radiant Research, Inc.	Akron	Ohio
United States	Achieve Clinical Research, Llc	Birmingham	Alabama
United States	Dallas Diabetes & Endocrine Center	Dallas	Texas
United States	Brain Matters Research	Delray Beach	Florida
United States	Physicians East P.A.	Greenville	North Carolina
United States	The Center For Pharmaceutical Research. Pc	Kansas City	Missouri
United States	Northwest Neurology Ltd.	Lake Barrington	Illinois
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Torrance Clinical Research	Lomita	California
United States	Office Of Richard S. Cherlin, Md	Los Gatos	California
United States	Commonwealth Biomedical Research, Llc	Madisonville	Kentucky
United States	Clinical Research Associates, Inc.	Nashville	Tennessee
United States	Renstar Medical Research	Ocala	Florida
United States	Compass Research, Llc	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Comprehensive Clinical Development, Inc.	St Petersburg	Florida
United States	Mercy Health Research	St. Louis	Missouri
United States	Neurology & Neuroscience Center Of Ohio	Toledo	Ohio
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Pmg Research Of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.		Up to 10 weeks	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Screening/Baseline Phase: Baseline	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 1	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 3	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 5	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 6	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 7	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 9	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Double-blind Treatment Phase: Week 10	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 12	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 16	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).		Open-Label Phase: Week 20	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 1	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 3	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 5	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 6	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 7	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 9	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Double-blind Treatment Phase: Week 10	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 2	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 4	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 8	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 12	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 16	No
Secondary	Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.		Open-Label Phase: Week 20	No
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Screening/Baseline Phase: Baseline	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 1	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 2	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 3	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 4	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 5	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 6	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 7	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 8	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 9	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Double-blind Treatment Phase: Week 10	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 2	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 4	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 8	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 12	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 16	Yes
Secondary	Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events.		Open-Label Phase: Week 20	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form