Diabetic Peripheral Neuropathic PainPhase 2NCT01314222
Diabetic Peripheral Neuropathic Pain (DPNP)
A Phase 2 study testing BMS-954561 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Bristol-Myers Squibb at 24 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- BMS-954561 and Pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 24 sitesin 2 countries
- Study dates
- Mar 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States21 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Achieve Clinical Research, Llc
Birmingham, Alabama, 35216
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
Brain Matters Research
Delray Beach, Florida, 33445
Physicians East P.A.
Greenville, North Carolina, 27834
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, 64114
Northwest Neurology Ltd.
Lake Barrington, Illinois, 60010
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Torrance Clinical Research
Lomita, California, 90717
Office Of Richard S. Cherlin, Md
Los Gatos, California, 95032
Commonwealth Biomedical Research, Llc
Madisonville, Kentucky, 42431
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203
Renstar Medical Research
Ocala, Florida, 34471
Compass Research, Llc
Orlando, Florida, 32806
Arizona Research Center
Phoenix, Arizona, 85023
Finger Lakes Clinical Research
Rochester, New York, 14618
Mercy Health Research
St Louis, Missouri, 63141
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, 33716
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, 27103
France3 sites
Local Institution
Dijon, 21079
Local Institution
Nantes, 44093
Local Institution
Nice, 06003
About this study
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)
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).
Read the detailed description
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- BMS-954561, Pregabalin, Placebo matching BMS-954561, Placebo matching Pregabalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-954561Drug
PregabalinDrug
Placebo matching BMS-954561Drug
Placebo matching PregabalinDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-954561 40mg or 80mg | Other | BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID
Active to Placebo or Placebo to Active (cross-over) Receives: Drug: BMS-954561; Drug: Placebo matching BMS-954561 |
| Arm 2: BMS-954561 150mg or 300mg | Other | BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID
Active to Placebo or Placebo to Active (cross-over) Receives: Drug: BMS-954561; Drug: Placebo matching BMS-954561 |
| Arm 3: Pregabalin 100mg | Other | Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID
Active to Placebo or Placebo to Active (cross-over) Receives: Drug: Pregabalin; Drug: Placebo matching Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
Measured: Up to 10 weeks
Secondary outcomes (50)
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Screening/Baseline Phase: Baseline
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 1
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 3
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 5
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 6
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 7
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 9
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Double-blind Treatment Phase: Week 10
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 12
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 16
Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF).
Measured: Open-Label Phase: Week 20
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 1
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 3
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 5
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 6
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 7
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 9
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Double-blind Treatment Phase: Week 10
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Open-Label Phase: Week 2
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Open-Label Phase: Week 4
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Open-Label Phase: Week 8
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Open-Label Phase: Week 12
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: Open-Label Phase: Week 16
Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Open-Label Phase: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314222
- Sponsor's protocol ID
- CN169-001
- Other IDs
- 2010-023042-70
- Status last verified
- Nov 2015
- First submitted
- 11 Feb 2011
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01314222
- Acronym / sponsor ID
- CN169-001
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-954561 40mg or 80mg | Other | Drug: BMS-954561, Drug: Placebo matching BMS-954561BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over) |
| Arm 2: BMS-954561 150mg or 300mg | Other | Drug: BMS-954561, Drug: Placebo matching BMS-954561BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over) |
| Arm 3: Pregabalin 100mg | Other | Drug: Pregabalin, Drug: Placebo matching PregabalinPregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-954561 | Drug | Arm 1: BMS-954561 40mg or 80mg, Arm 2: BMS-954561 150mg or 300mg |
| Pregabalin | Drug | Arm 3: Pregabalin 100mg |
| Placebo matching BMS-954561 | Drug | Arm 1: BMS-954561 40mg or 80mg, Arm 2: BMS-954561 150mg or 300mg |
| Placebo matching Pregabalin | Drug | Arm 3: Pregabalin 100mg |
Primary outcome
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo.
Time frame: Up to 10 weeks
50 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-954561 and Pregabalin in people with Diabetic Peripheral Neuropathic Pain, run by Bristol-Myers Squibb at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.