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PainPhase 2NCT00964990

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

A Phase 2 study testing JNJ-42160443 in people with Pain and Neuralgia, Postherpetic, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 48 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain, Neuralgia, Postherpetic, Neuralgia
What is being tested?
JNJ-42160443
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
48 sitesin 4 countries
Study dates
Sep 2009to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

48 sites in 4 countries.

48 sites in 4 countries

United States40 sites

  • Study site

    Albany, New York

  • Study site

    Allentown, Pennsylvania

  • Study site

    Altoona, Pennsylvania

  • Study site

    Ann Arbor, Michigan

  • Study site

    Boise, Idaho

  • Study site

    Boston, Massachusetts

  • Study site

    Brockton, Massachusetts

  • Study site

    Charlotte, North Carolina

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Evansville, Indiana

  • Study site

    Franklin, Indiana

  • Study site

    Fresno, California

  • Study site

    Greer, South Carolina

  • Study site

    Hickory, North Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Hyannis, Massachusetts

  • Study site

    Lewiston, Idaho

  • Study site

    Lexington, Kentucky

  • Study site

    Meridian, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New York, New York

  • Study site

    Oldsmar, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Palm Beach Gardens, Florida

  • Study site

    Pennsburg, Pennsylvania

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Port Orange, Florida

  • Study site

    Redondo Beach, California

  • Study site

    Rochester, New York

  • Study site

    Roseville, California

  • Study site

    San Antonio, Texas

  • Study site

    Shreveport, Louisiana

  • Study site

    Smyrna, Tennessee

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Sunrise, Florida

  • Study site

    Tamarac, Florida

  • Study site

    Tucson, Arizona

Other trials in United States

Belgium3 sites

  • Study site

    Edegem

  • Study site

    Leuven

  • Study site

    Waterschei-Zwartberg

Other trials in Belgium

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    Valencia

Other trials in Spain

Netherlands2 sites

  • Study site

    Alkmaar

  • Study site

    Maastricht

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
JNJ-42160443, Placebo
Keywords
Moderate to severe chronic peripheral neuropathic pain, Postherpetic neuralgia, Post-traumatic neuralgia, Moderate to severe chronic pain, JNJ-42160443
Medical subject headings
Pain, Neuralgia, Postherpetic, Neuralgia, Mononeuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-42160443Drug

    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

  • PlaceboDrug

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

Study groups in NCT00964990
Study groupRoleWhat they receive
001ExperimentalJNJ-42160443 SC injection (1 3 or 10 milligrams) once every 28 days
Receives: Drug: JNJ-42160443
002Placebo comparatorPlacebo SC injection once every 28 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The daily evening assessment of average pain intensity

    Measured: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase

Secondary outcomes (4)

  1. Pain at its worst

    Measured: Daily for 12 weeks

  2. Brief Pain Inventory

    Measured: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)

  3. Neuropathic pain symptom inventory

    Measured: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)

  4. Patient Global Impression of Change

    Measured: Up to Week 13 (ie, at Visits 1, 3, 7, 8, 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2011
  4. Study completionJul 2011

Why it stopped: Logistic reasons associated with the FDA-imposed clinical hold.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00964990
Sponsor's protocol ID
CR016474
Other IDs
42160443NPP2001, 2008-007478-39, 2008
Status last verified
Mar 2016
First submitted
21 Aug 2009
Last updated
2 May 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 27153360

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-42160443 in people with Pain and Neuralgia, Postherpetic, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 48 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Belgium, Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Logistic reasons associated with the FDA-imposed clinical hold.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The daily evening assessment of average pain intensity (time frame: Baseline (7 days before randomization) and last 7 days of the 12-week treatment phase). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00964990, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.

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Clinical Trial NCT00964990 | AzTrials