ESTUDIO MULTICÉNTRICO, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE JNJ-42160443 EN PACIENTES CON NEURALGIA POSTHERPÉTICA Y NEURALGIA POSTRAUMÁTICA, SEGUIDO DE UN PERIODO DE EXTENSIÓN DOBLE CIEGO DE SEGURIDAD Y UNA EXTENSIÓN ABIERTA DE SEGURIDAD.

Conditions: europathic Pain in Postherpetic Neuralgia and Post-traumatic NeuralgiaDolor Neuropático en Neuralgia Postherpetica y Neuralgia Post traumatica
MedDRA version: 12.0Level: LLTClassification code 10029223Term: Neuralgia
MedDRA version: 12.0Level: LLTClassification code 10036376Term: Post herpetic neuralgia
MedDRA version: 12.0Level: LLTClassification code 10054095Term: Neuropathic pain

Registration Number: EUCTR2008-007478-39-ES

Lead Sponsor: Janssen Cilag International, N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

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 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 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 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)
? 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 fol

Exclusion Criteria

? History of 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, 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
? 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 90 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).
? His