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    Summary
    EudraCT Number:2008-007478-39
    Sponsor's Protocol Code Number:42160443NPP2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-007478-39
    A.3Full title of the trial
    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
    A.4.1Sponsor's protocol code number42160443NPP2001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Cilag International, NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameJNJ42160443
    D.3.2Product code JNJ42160443
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ42160443
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeFully human recombinant monoclonal antibody (IgG2)
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postherpetic Neuralgia and Post-Traumatic Neuralgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029223
    E.1.2Term Neuralgia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia
    • To evaluate the safety and tolerability of multiple doses of JNJ-42160443 (1, 3, and 10 mg), when administered as a single, subcutaneous injection every 28 days to subjects with postherpetic neuralgia for up to 2 years
    E.2.2Secondary objectives of the trial
    • To evaluate the analgesic efficacy of JNJ-42160443 (10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity in subjects with posttraumatic neuralgia
    • To evaluate the safety and tolerability of multiple doses of JNJ-42160443 (10 mg) when administered as a single, subcutaneous injection every 28 days to subjects with posttraumatic neuralgia for up to 2 years
    • To evaluate the efficacy of JNJ-42160443 with respect to alternative pain endpoints (e.g. evening assessment of pain at its worst in the last 24 hours, neuropathic pain symptoms, pain severity, and pain-related interference with activities, Patient Global Impression of Change)
    • To evaluate the pharmacokinetics of JNJ-42160443 following multiple dose administrations.
    • To evaluate the immunogenicity (antibodies to JNJ-42160443) associated with JNJ 42160443 treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Man or woman between 18 and 80 years of age, inclusive
    • Subjects who have chronic neuropathic pain (pain persistent for greater than 6 months) that is moderate to severe in the opinion of the investigators) and are currently taking neuropathic pain medication but are not adequately controlled by standard of care (which may include antidepressants, antiepileptics, topical lidocaine, or opiods) or are not currently taking neuropathic pain medications because they are intolerable to, or not willing to use, standard of care.
    • Subjects currently taking medications for the treatment of neuropathic pain at Screening have 3 options:
    – They may continue taking their current pain medication: Subjects are required to be on a stable dose for at least 4 weeks prior to the first dose of study drug and must remain on this dose for the duration of the double blind efficacy phase. The class, number, and doses of medications for the treatment of neuropathic pain are limited to the guidelines provided below (refer to Maximal Neuropathic Pain Medication Allowed). If the number and/or doses of such medications must be reduced to fall within the acceptable limits for this study, then the number and/or doses must be reduced (see next bullet).
    – They may reduce the number and/or dose of their current pain medications: If the number and/or dose exceed the limits of allowed neuropathic pain medications (refer to Maximal Neuropathic Pain Medication Allowed), then the number and/or dose must be reduced to fall within acceptable limits. This must be achieved at least 3 days or 5-half lives of the pain medication taken (whichever is longer) prior to the beginning of the Interactive Voice Response System (IVRS) baseline period. Medications with the potential to cause withdrawal symptoms should be tapered using a taper schedule that is determined by the investigator. Subjects must remain on this lowered number/dose of pain medication dose for the duration of the double blind efficacy phase.
    – They may discontinue their current pain medication: If they choose to discontinue their neuropathic pain medications, then a washout interval of 3 days or 5 half lives of the pain medication taken, whichever is longer, prior to beginning the IVRS baseline period is required. Medications with the potential to cause withdrawal symptoms should be tapered using a taper schedule that is determined by the investigator.
    Maximal pain medication allowed: Use of two or less of the following medications, each one from a different class, is permitted:
    – Anticonvulsants: gabapentin (≤ 1800 mg/day) or pregabalin (≤ 300 mg/day)
    – Opioid analgesics (≤ 60 mg/day oxycodone equivalent) or tramadol (≤ 200 mg/day)
    – Antidepressants: tricyclic antidepressants (≤ 75 mg/day amitriptyline equivalent), duloxetine (≤ 60 mg/day), or venlafaxine (≤ 150 mg/day). Sponsor approval is required for the use of any other SNRI antidepressant for the treatment of neuropathic pain not listed here.

    Note: Medications for treatment of neuropathic pain are limited to the guidelines provided above (refer to Maximal Neuropathic Pain Medication Allowed). No other classes of neuropathic pain medications (e.g., topical lidocaine, capsaicin, botulinum toxin) are permitted.

    • Subjects must have a mean average pain intensity score of at least 5, but less than 10, over 7 consecutive days on an 11-point numerical rating scale during the IVRS baseline period. Subjects are not permitted to have a pain score of less than 3 on 2 or more days within the 7 consecutive days. During the 7 consecutive days, at least 5 days of scores are required.
    • Subjects with PHN:
    o Diagnosis of PHN includes a clear history of herpetic (varicella-zoster) rash and persistent pain in a dermatomal distribution area
    o Pain must be present for greater than 6 months after the onset of the dermatomal rash
    • Subjects with post-traumatic neuralgia are required to have all of the following:
    o The persistent pain was related to nerve injury caused by trauma or surgery for longer than 6 months, and is not associated with an ongoing infection. Examples include thoracotomy, inguinal herniorrhaphy, knee or hip replacement, sternotomy, plastic surgery, or traumatic injury. Subjects with failed back pain syndromes or spine disease, radiculopathy, or complex regional pain syndrome (CRPS) type I should not be considered as the posttraumatic neuralgia diagnosis for the purpose of this study.
    o Neuropathic pain diagnostic questionnaire (Douleur neuropathic 4 questionnaire) score of 4 or more based on investigator’s assessment (Attachment 26; Bouhissira 2005)
    E.4Principal exclusion criteria
    • A separate pain condition (e.g., joint osteoarthritis) that is more severe than their pain due to their diagnosis of PHN or post-traumatic neuralgia, or, if in the opinion of the Investigator, the chronic pain condition could confound the subject’s assessment of neuropathic pain under this study
    • Subjects with post-traumatic neuralgia that are characteristic of complex regional pain syndrome Type I, including: pain out of proportion to the severity of the injury, pain outside the distribution of nerve injury, changes in the skin color and/or temperature in the affected limb or body part, edema or excessive sweating of the affected limb or body part. Note, subjects with Type II CRPS are allowed in the study.
    • Subjects with lumbar-sacral radiculopathy that does not have a stable pattern of symptoms for at least 6 months prior to Screening, failed low-back surgery, or spinal cord injury.
    • Subject whose nerve injury or pain is expected to recover in the next 4 months
    • Subjects 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
    • History of ocular herpes simplex, HSV pneumonia, or HSV encephalitis
    • Primary HSV infection or prophylactic therapy for HSV within the past 2 years
    • Recurrent HSV reactivation during the past 2 years consisting of ≥4 episodes/year or requiring antiviral treatment
    • Currently receiving chronic systemic immunosuppressive therapy
    • 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 posttraumatic neuralgia under the study
    • Participation in an analgesia trial within 30 days of the first planned dose of study drug.
    • Major surgeries (general or regional anesthesia), trauma, and nonhealing wounds/ulcers within 3 months prior to study drug
    • History (within 1 year) of seizure, intrathecal therapy and ventricular shunts, radiotherapy to the cerebral area, mild or moderate traumatic brain injury, transient ischemic attack, or stroke, or meningitis
    • History of severe traumatic brain injury within the past 15 years (consisting of 1 or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post-traumatic amnesia lasting more than 24 hours) or with residual sequelae suggesting ongoing transient changes in consciousness
    • History of epilepsy or multiple sclerosis
    • In the investigator’s opinion, in consultation with the medical neurologist, any other conditions that could compromise the blood-brain barrier
    • History of a malignancy (within the past 5 years) or current malignancy with the exception of basal cell carcinoma that has been treated and is no longer present
    • Received an investigational drug (including vaccines) or used an investigational medical device within 30 days before the planned start of treatment (or 5 half-lives of the investigational drug, whichever is longer) or are currently enrolled in an investigational study.
    • Women who are pregnant or breast-feeding
    • Significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (e.g., schizophrenia, bipolar disorder, dementia), immunological (e.g., immune deficiency), or metabolic disturbances
    • Type I or Type II diabetes, based on medical history or laboratory results consistent with diabetes mellitus (i.e. fasting plasma glucose ≥126 mg/dl or ≥7 mmol/L)
    • Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) ≥ 2.5 times the upper limit of normal (ULN).
    • Serum creatinine of ≥ 1.8 mg/dL
    • Active, major depression or generalized anxiety disorder, recent episode of either disorder within the past 3 months, and subjects with a BDI II score ≥ 29 (Attachment 1 of protocol).
    • History of suicide attempts or suicidal ideation in the past year
    • Clinical diagnosis of human immunodeficiency virus (HIV) infection or clinical diagnosis of acquired immunodeficiency syndrome (AIDS) or any immune deficiency. Subjects with HIV infection, according to the interpretation of the Screening serology test results, will be excluded.
    • Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients, including mammalian cell-derived (ie., Chinese hamster ovary) products
    • Use of disallowed therapies as listed in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy evaluation is the daily evening assessment of average pain intensity over the last 24 hours using an 11-point numerical rating scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.

    The primary efficacy endpoint is the mean of the daily evening assessment of average pain intensity over the last 24 hours for the last 7 days of the double-blind efficacy phase minus the mean from the 7-day baseline period (7 days prior to the first dose of study drug).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    open label in safety extension
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Plans for treatment or care after the subject has ended his/her participation in the trial is no different from the standard of care for this condition.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-23
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