Clinical trial NCT00964990: A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain
Neuralgia, Postherpetic
Neuralgia
Mononeuropathies
Keywords: Moderate to severe chronic peripheral neuropathic pain
Postherpetic neuralgia
Post-traumatic neuralgia
Moderate to severe chronic pain
JNJ-42160443
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The daily evening assessment of average pain intensity
timeFrame: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase
Secondary outcomes:
measure: Pain at its worst
timeFrame: Daily for 12 weeks
measure: Brief Pain Inventory
timeFrame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
measure: Neuropathic pain symptom inventory
timeFrame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
measure: Patient Global Impression of Change
timeFrame: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: Redondo Beach
country: United States
state: California
city: Roseville
country: United States
state: California
city: Hollywood
country: United States
state: Florida
city: Oldsmar
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Port Orange
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Lewiston
country: United States
state: Idaho
city: Evansville
country: United States
state: Indiana
city: Franklin
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Hyannis
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Meridian
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Ny
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Allentown
country: United States
state: Pennsylvania
city: Altoona
country: United States
state: Pennsylvania
city: Pennsburg
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Smyrna
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Waterschei-Zwartberg
country: Belgium
city: Alkmaar
country: Netherlands
city: Maastricht
country: Netherlands
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.