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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-label Safety Extension

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Mononeuropathies; Neuralgia; Neuralgia, Postherpetic
• Intervention / Treatment: Drug: JNJ-42160443; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium
  • Leuven, Belgium
  • Waterschei-Zwartberg, Belgium
• Netherlands
  • Alkmaar, Netherlands
  • Maastricht, Netherlands
• Spain
  • Barcelona, Spain
  • Madrid, Spain
  • Valencia, Spain
• United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Fresno, California, United States
    • Redondo Beach, California, United States
    • Roseville, California, United States
  • Florida
    • 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
  • Georgia
    • Decatur, Georgia, United States
  • Idaho
    • Boise, Idaho, United States
    • Lewiston, Idaho, United States
  • Indiana
    • Evansville, Indiana, United States
    • Franklin, Indiana, United States
  • Kentucky
    • Lexington, Kentucky, United States
  • Louisiana
    • Shreveport, Louisiana, United States
  • Massachusetts
    • Boston, Massachusetts, United States
    • Brockton, Massachusetts, United States
    • Hyannis, Massachusetts, United States
  • Michigan
    • Ann Arbor, Michigan, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Jersey
    • Meridian, New Jersey, United States
  • New York
    • Albany, New York, United States
    • Ny, New York, United States
    • Rochester, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Hickory, North Carolina, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States
    • Altoona, Pennsylvania, United States
    • Pennsburg, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
  • South Carolina
    • Greer, South Carolina, United States
  • Tennessee
    • Nashville, Tennessee, United States
    • Smyrna, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Plano, Texas, United States
    • San Antonio, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients diagnosed with postherpetic neuralgia or post-traumatic neuralgia and who have chronic neuropathic pain (pain persistent for > 6 months) that is moderate to severe; Currently taking pain medication but are not adequately controlled by standard of care or are not currently taking pain medications because intolerable to, or not willing to use, standard of care. Exclusion Criteria: History 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 001; JNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days	Drug: 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
PLACEBO_COMPARATOR: 002; Placebo SC injection once every 28 days	Drug: Placebo; Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The daily evening assessment of average pain intensity	Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain at its worst	Daily for 12 weeks
Brief Pain Inventory	Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Neuropathic pain symptom inventory	Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Patient Global Impression of Change	Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: August 21, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (ESTIMATE): August 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 2, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Postherpetic neuralgia; JNJ-42160443; Moderate to severe chronic peripheral neuropathic pain; Post-traumatic neuralgia; Moderate to severe chronic pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Mononeuropathies
• Other Study ID Numbers: CR016474; 42160443NPP2001 (OTHER: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.); 2008-007478-39 (EUDRACT_NUMBER)