Diabetic Peripheral Neuropathic Pain (DPNP)
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Bristol-Myers Squibb
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
BS
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
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.
See 2 more
Treatment Details
Interventions
- BMS-954561 (Other)
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Arm 3: Pregabalin 100mgExperimental Treatment2 Interventions
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID
Active to Placebo or Placebo to Active (cross-over)
Group II: Arm 2: BMS-954561 150mg or 300mgExperimental Treatment2 Interventions
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Active to Placebo or Placebo to Active (cross-over)
Group III: Arm 1: BMS-954561 40mg or 80mgExperimental Treatment2 Interventions
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID
Active to Placebo or Placebo to Active (cross-over)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania