A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia)

NCT ID: NCT00964990

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-07-31

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of JNJ-42160443 in the treatment of moderate to severe neuropathic pain in patients with a diagnosis of postherpetic neuralgia and post-traumatic neuralgia.

Detailed Description

The current study is a randomized (study drug assigned by chance), double-blind (neither the study doctor nor the patient knows the name of the assigned drug), placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of JNJ-42160443 in patients with postherpetic neuralgia and post-traumatic neuralgia, followed by a double blind extension and an open-label (study doctor and patient knows the name of the study drug) extension. This study will evaluate the safety and effectiveness of JNJ-42160443 in the treatment of patients with moderate to severe, chronic, neuropathic pain that is not controlled with or without standard pain therapy and who have a diagnosis of postherpetic neuralgia (PHN) or post-traumatic neuralgia. The total duration of the study will be approximately 130 weeks (i.e., includes screening phase, 12-week double-blind efficacy phase, double-blind safety extension phase, and the open-label safety extension phase). During the 12 week treatment and 40 week double-blind extension phases, PHN patients will receive Placebo, JNJ 42160443 1, 3, or 10 mg and post-traumatic neuralgia patients will receive placebo or JNJ-42160443 10 mg; all doses will be given as a single, subcutaneous (under the skin) (SC) injection every 28 days. During the 52-week open-label extension phase, all patients will receive a single SC injection of JNJ-42160443 up to 10 mg every 4, 8, or 12 weeks.

Conditions

Pain; Neuralgia, Postherpetic; Neuralgia; Mononeuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

001

JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days

Group Type: EXPERIMENTAL

JNJ-42160443

Intervention Type: DRUG

Type=exact number, unit=mg, number= 1, 3, or 10, form=solution for injection, route=Subcutaneous use. One injection of 1, 3, or 10 mg of JNJ-42160443 every 28 days for up to 52 wks and then every 4, 8, or 12 weeks for up to an additional 52 weeks

002

Placebo SC injection once every 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks

Interventions

JNJ-42160443

Type=exact number, unit=mg, number= 1, 3, or 10, form=solution for injection, route=Subcutaneous use. One injection of 1, 3, or 10 mg of JNJ-42160443 every 28 days for up to 52 wks and then every 4, 8, or 12 weeks for up to an additional 52 weeks

Intervention Type: DRUG

Placebo

Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I
• Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury
• Patient whose nerve injury or pain is expected to recover in the next 4 months
• Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection
• Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study
• Women who are pregnantHistory of a separate pain condition (e.g., joint osteoarthritis) that is more severe than pain due to diagnosis of PHN or post-traumatic neuralgia; Patients with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I; Patients with lumbar-sacral radiculopathy, failed low-back surgery, or spinal cord injury; Patient whose nerve injury or pain is expected to recover in the next 4 months; Patients with evidence of another neuropathic pain not under study, such as pain resulting from diabetic painful neuropathy, sensory neuropathies or pain caused by radiation, chemotherapy, alcohol, HIV infection; Other peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms that is not related with the PHN or post-traumatic neuralgia under the study; Women who are pregnant or breast-feeding; Type I or Type II diabetes.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Tucson, Arizona, United States

Fresno, California, United States

Redondo Beach, California, United States

Roseville, California, United States

Hollywood, Florida, United States

Oldsmar, Florida, United States

Palm Beach Gardens, Florida, United States

Port Orange, Florida, United States

St. Petersburg, Florida, United States

Sunrise, Florida, United States

Tamarac, Florida, United States

Decatur, Georgia, United States

Boise, Idaho, United States

Lewiston, Idaho, United States

Evansville, Indiana, United States

Franklin, Indiana, United States

Lexington, Kentucky, United States

Shreveport, Louisiana, United States

Boston, Massachusetts, United States

Brockton, Massachusetts, United States

Hyannis, Massachusetts, United States

Ann Arbor, Michigan, United States

St Louis, Missouri, United States

Omaha, Nebraska, United States

Meridian, New Jersey, United States

Albany, New York, United States

New York, New York, United States

Rochester, New York, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Allentown, Pennsylvania, United States

Altoona, Pennsylvania, United States

Pennsburg, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Greer, South Carolina, United States

Nashville, Tennessee, United States

Smyrna, Tennessee, United States

Dallas, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Edegem, , Belgium

Leuven, , Belgium

Waterschei-Zwartberg, , Belgium

Alkmaar, , Netherlands

Maastricht, , Netherlands

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Countries

United States; Belgium; Netherlands; Spain

References

Wang H, Romano G, Fedgchin M, Russell L, Sanga P, Kelly KM, Frustaci ME, Thipphawong J. Fulranumab in Patients With Pain Associated With Postherpetic Neuralgia and Postraumatic Neuropathy: Efficacy, Safety, and Tolerability Results From a Randomized, Double-blind, Placebo-controlled, Phase-2 Study. Clin J Pain. 2017 Feb;33(2):99-108. doi: 10.1097/AJP.0000000000000388.

Reference Type: DERIVED

PMID: 27153360 (View on PubMed)

Other Identifiers

42160443NPP2001

Identifier Type: OTHER

Identifier Source: secondary_id

2008-007478-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016474

Identifier Type: -

Identifier Source: org_study_id