Crossover Post-herpetic Neuralgia (PHN)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01305538
• Collaborator: (none)
• Enrollment: 100
• Locations: 23
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 post-herpetic neuralgia (PHN).

Condition or Disease	Intervention/Treatment	Phase
Post-Herpetic Neuralgia (PHN)	Drug: BMS-954561; Drug: BMS-954561; Drug: Placebo	Phase 2

Detailed Description

Allocation: Randomized Stratified

Interventional model: Cross-over Placebo Controlled

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Post-herpetic Neuralgia (PHN)
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1 BMS-954561 40mg or 80mg Arm description: BMS-954561 40mg or 80mg three times daily (TID) to Placebo OR Placebo to 40mg or 80mg TID. Arm type: Active to Placebo or Placebo to Active (cross-over)	Drug: BMS-954561; Drug: Placebo
Other: Arm 2 BMS-954561 150mg or 300mg Arm description: BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Arm type: Active to Placebo or Placebo to Active(cross-over)	Drug: BMS-954561; Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [up to 10 weeks]

Secondary Outcome Measures

1. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Screening/Baseline Phase: Baseline]

2. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 1]

3. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 2]

4. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 3]

5. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 4]

6. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 5]

7. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 6]

8. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 7]

9. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 8]

10. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 9]

11. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Double-blind Treatment Phase: Weeks 10]

12. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 2]

13. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 4]

14. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 8]

15. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 12]

16. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 16]

17. Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [Open-Label Phase: Weeks 20]

18. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 1]

19. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 2]

20. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 3]

21. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 4]

22. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 5]

23. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 6]

24. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 7]

25. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 8]

26. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 9]

27. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Double-blind Treatment Phase: Weeks 10]

28. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 2]

29. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 4]

30. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 8]

31. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 12]

32. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 16]

33. Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [Open-Label Phase: Weeks 20]

34. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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]

35. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 1]

36. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 2]

37. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 3]

38. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 4]

39. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 5]

40. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 6]

41. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 7]

42. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 8]

43. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 9]

44. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia 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: Weeks 10]

45. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 2]

46. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 4]

47. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 8]

48. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 12]

49. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 16]

50. Evaluate the tolerability and safety of BMS-954561 in patients with post-herpetic neuralgia as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [Open-Label Phase: Weeks 20]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient with Post-Herpetic Neuralgia (PHN) as defined as pain present for more than 6 months after the onset of a herpes zoster skin rash affecting the trigeminal, cervical, thoracic, lumbar, or sacral regions.

• Based on patient diary information collected during the Baseline week (day -7 to randomization Day 1), patient has completed at least 5 diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale.

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

• Male or female, 18-85 years of age.

Exclusion Criteria:

• Other severe pain that may potentially confound pain assessment.

• 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).

• Hemoglobin A1c > 9%

• Hemoglobin ≤ 9 g/dL.

• Active herpes zoster or known viral infection.

• Previous neurolytic or neurosurgical therapy for PHN.

• Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 40ml/min/1.73m2.

• Patients who have been on a stable dose of anticonvulsant,anticholinergic, antiviral medications, nicotine replacements, or any other smoking cessation medications 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, antidepressants, or anticonvulsants). Patients are allowed to participate if on a stable dose for at least 4 weeks prior to randomization (Day1) and should remain stable during course of study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Research Center	Phoenix	Arizona	United States	85023
2	Torrance Clinical Research	Lomita	California	United States	90717
3	Alpine Clinical Research Center	Boulder	Colorado	United States	80304
4	Brain Matters Research	Delray Beach	Florida	United States	33445
5	Renstar Medical Research	Ocala	Florida	United States	34471
6	Compass Research, Llc	Orlando	Florida	United States	32806
7	Comprehensive Clinical Development, Inc.	St Petersburg	Florida	United States	33716
8	Drug Studies America	Marietta	Georgia	United States	30060
9	Commonwealth Biomedical Research, Llc	Madisonville	Kentucky	United States	42431
10	Analgesic Solutions	Natick	Massachusetts	United States	01760
11	Quest Research Institute	Farmington Hills	Michigan	United States	48334
12	The Center For Pharmaceutical Research. Pc	Kansas City	Missouri	United States	64114
13	Medex Healthcare Research, Inc	St. Louis	Missouri	United States	63117
14	Finger Lakes Clinical Research	Rochester	New York	United States	14618
15	Wake Research Associates, Llc	Raleigh	North Carolina	United States	27612
16	Pmg Research Of Winston-Salem	Winston-Salem	North Carolina	United States	27103
17	Radiant Research, Inc.	Akron	Ohio	United States	44311
18	Cor Clinical Research	Oklahoma City	Oklahoma	United States	73103
19	Futuresearch Trials Of Neurology	Austin	Texas	United States	78731
20	Local Institution	Bordeaux Cedex		France	33076
21	Local Institution	Boulogne-Billancourt		France	92100
22	Local Institution	Nice Cedex 1		France	06003
23	Local Institution	Saint Priest En Jarez		France	42277

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01305538
• Other Study ID Numbers: CN169-002; 2010-023041-30
• First Posted: Feb 28, 2011
• Last Update Posted: Dec 7, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Neuralgia; Neuralgia, Postherpetic

Study Results

No Results Posted as of Dec 7, 2015