Study Stopped
Logistic reasons associated with the FDA-imposed clinical hold.
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
3 other identifiers
interventional
112
4 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 pain
Started Sep 2009
Typical duration for phase_2 pain
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 2, 2016
March 1, 2016
1.8 years
August 21, 2009
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The daily evening assessment of average pain intensity
Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase
Secondary Outcomes (4)
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)
Study Arms (2)
001
EXPERIMENTALJNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days
002
PLACEBO COMPARATORPlacebo SC injection once every 28 days
Interventions
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
Form=solution for injection, route=Subcutaneous injection. One injection of matching placebo every 28 days for up to 52 wks
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Redondo Beach, California, United States
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Roseville, California, United States
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Hollywood, Florida, United States
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Oldsmar, Florida, United States
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Palm Beach Gardens, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
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Tamarac, Florida, United States
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Decatur, Georgia, United States
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Boise, Idaho, United States
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Lewiston, Idaho, United States
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Evansville, Indiana, United States
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Franklin, Indiana, United States
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Lexington, Kentucky, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Hyannis, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Meridian, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Hickory, North Carolina, United States
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Allentown, Pennsylvania, United States
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Altoona, Pennsylvania, United States
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Pennsburg, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greer, South Carolina, United States
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Nashville, Tennessee, United States
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Smyrna, Tennessee, United States
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Dallas, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Edegem, Belgium
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Leuven, Belgium
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Waterschei-Zwartberg, Belgium
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Alkmaar, Netherlands
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Maastricht, Netherlands
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Barcelona, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Valencia, Spain
Related Publications (1)
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.
PMID: 27153360DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2009
First Posted
August 25, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
May 2, 2016
Record last verified: 2016-03