Clinical trial NCT01314222: Diabetic Peripheral Neuropathic Pain (DPNP)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Peripheral Neuropathic Pain
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Screening/Baseline Phase: Baseline
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 1
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 2
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 3
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 4
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 5
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 6
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 7
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 8
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 9
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Double-blind Treatment Phase: Week 10
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 2
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 4
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 8
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 12
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 16
measure: Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
timeFrame: Open-Label Phase: Week 20
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 1
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 2
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 3
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 4
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 5
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 6
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 7
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 8
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 9
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Double-blind Treatment Phase: Week 10
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 2
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 4
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 8
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 12
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 16
measure: Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
timeFrame: Open-Label Phase: Week 20
measure: 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.
timeFrame: Screening/Baseline Phase: Baseline
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 1
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 2
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 3
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 4
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 5
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 6
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 7
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 8
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 9
measure: 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.
timeFrame: Double-blind Treatment Phase: Week 10
measure: 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.
timeFrame: Open-Label Phase: Week 2
measure: 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.
timeFrame: Open-Label Phase: Week 4
measure: 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.
timeFrame: Open-Label Phase: Week 8
measure: 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.
timeFrame: Open-Label Phase: Week 12
measure: 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.
timeFrame: Open-Label Phase: Week 16
measure: 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.
timeFrame: Open-Label Phase: Week 20
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, Llc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: Los Gatos
country: United States
facility: Office Of Richard S. Cherlin, Md
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: St Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc.
state: Florida
city: Lake Barrington
country: United States
facility: Northwest Neurology Ltd.
state: Illinois
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, Llc
state: Kentucky
city: Kansas City
country: United States
facility: The Center For Pharmaceutical Research. Pc
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Greenville
country: United States
facility: Physicians East P.A.
state: North Carolina
city: Winston-Salem
country: United States
facility: Pmg Research Of Winston-Salem
state: North Carolina
city: Akron
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center Of Ohio
state: Ohio
city: Nashville
country: United States
facility: Clinical Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes & Endocrine Center
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Dijon Cedex
country: France
facility: Local Institution
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Nice Cedex 1
country: France
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: