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).
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
178
Achieve Clinical Research, Llc
Birmingham, Alabama, United States
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
Time frame: Up to 10 weeks
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Screening/Baseline Phase: Baseline
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 1
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 3
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 5
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 6
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 7
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...and 14 more locations
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 9
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Double-blind Treatment Phase: Week 10
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 12
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 16
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Time frame: Open-Label Phase: Week 20
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 1
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 3
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 5
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 6
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 7
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 9
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Double-blind Treatment Phase: Week 10
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 12
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 16
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Time frame: Open-Label Phase: Week 20
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.
Time frame: Screening/Baseline Phase: Baseline
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.
Time frame: Double-blind Treatment Phase: Week 1
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.
Time frame: Double-blind Treatment Phase: Week 2
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.
Time frame: Double-blind Treatment Phase: Week 3
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.
Time frame: Double-blind Treatment Phase: Week 4
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.
Time frame: Double-blind Treatment Phase: Week 5
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.
Time frame: Double-blind Treatment Phase: Week 6
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.
Time frame: Double-blind Treatment Phase: Week 7
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.
Time frame: Double-blind Treatment Phase: Week 8
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.
Time frame: Double-blind Treatment Phase: Week 9
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.
Time frame: Double-blind Treatment Phase: Week 10
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.
Time frame: Open-Label Phase: Week 2
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.
Time frame: Open-Label Phase: Week 4
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.
Time frame: Open-Label Phase: Week 8
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.
Time frame: Open-Label Phase: Week 12
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.
Time frame: Open-Label Phase: Week 16
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.
Time frame: Open-Label Phase: Week 20