Dose-Finding Study of REN-1654 in Patients With Post-Herpetic Neuralgia

NCT00099528 | Unknown Phase 2

• 1 other identifier: REN-1654-2-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with painful post-herpetic neuralgia (PHN).

Conditions

Neuralgia; Shingles; Peripheral Nervous System Disease

Keywords

Post-herpetic neuralgia; Shingles; Herpes Zoster; Neuropathic pain; Neuralgia; Anti-TNF agents; Inflammatory cytokines; Hyperalgesia; Allodynia; Irritable nociceptor

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the Daily Spontaneous Pain Rating in the most painful area identified at baseline and screening.

Secondary Outcomes (5)

• (1) Daily Allodynia Rating

• (2) Daily Functional Interference Rating for general activity and sleep

• (3) Pain Relief Rating (recorded at study visits)

• (4) Neuropathic Pain Rating (recorded at study visits)

• (5) Evoked Allodynia Rating (recorded at study visits)

Interventions

REN-1654 DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females, aged 55 years or older, able and willing to provide written informed consent to participate in the study.
• Able to read, understand and follow the study instructions, including completion of pain intensity rating scales.
• History of herpes zoster cutaneous rash, followed by persistent pain for 2 to 18 months after the onset of the rash until the time of dosing with study medication.
• A screening Daily Spontaneous Pain Rating (for the prior 24-hour period) of at least 4, using an 11-point categorical pain intensity scale with 0 as "no pain" and 10 as "the worst pain imaginable".
• A positive (non-zero) Evoked Allodynia score reported at the time of screening using the categorical pain intensity scale in response to at least one of two stimuli: light stroking with a foam brush, or #14 von Frey hair stimulation.
• Subjects who are compliant in maintaining a Pain Diary between the screening and baseline visits, and who record a Daily Spontaneous Pain Rating score of 4 or greater on at least 3 days during the week prior to the baseline visit.
• Subjects who at screening are taking analgesics, antidepressants, anticonvulsants, anxiolytics, or muscle relaxants, must have been on each such medication for 4 weeks, and at stable doses for 2 weeks prior to the baseline visit, and must be maintained on the same doses throughout the study.
• Subjects who at screening are receiving adjunctive analgesic therapy such as acupuncture or biofeedback should either discontinue it or establish a schedule of treatments that will remain consistent for 2 weeks prior to the baseline visit, and throughout the study.
• Subjects who agree to discontinue topical pain treatments at least 2 weeks before the baseline visit, and agree not to use them during the study.
• Subjects who agree that they will not receive local, regional or spinal (articular, epidural, or intrathecal) injections of medication for pain treatments within 2 weeks prior to the baseline visit and through the end of the study.
• If female, must be post-menopausal, surgically sterile, not currently pregnant (verified by a screening pregnancy test) or nursing, and using a reliable contraception method such as intrauterine device (IUD), hormonal birth control pills, or double-barrier method (male condom, female condom or diaphragm with spermicidal jelly).
• If male, must agree to use double-barrier methods of contraception.

You may not qualify if:

• History of peripheral neuropathy or any chronic pain condition other than PHN.
• History of hepatic, cardiovascular, renal, gastrointestinal, hematological, neurological, endocrine (including diabetes), metabolic, pulmonary, immunologic (including HIV) or psychiatric disease that in the opinion of the Investigator would pose a significant safety risk for a subject exposed to an investigational compound such as REN-1654, or could significantly diminish the quality of the efficacy data to be collected in the study.
• History of the following ophthalmic disorders based upon medical review at the screening visit. Subjects will further undergo a screening ophthalmologic assessment. Should any of the following be identified at the screening ophthalmologic examination, the subject will be excluded from the study.
• Symptomatic cataract, resulting in any visual impairment (if a subject has been diagnosed with cataract to a degree that the cataract interferes with daily living and/or regarding which an ophthalmologist has recommended cataract surgery);
• Herpes zoster ophthalmicus involving the eyeball (if a subject has a history of herpes zoster ophthalmicus causing inflammation of any part of the eye \[conjunctiva, cornea, iris, retina, optic nerve\]; subjects who only had cutaneous herpes zoster involvement of the eyelid without involvement of the eye may be eligible for the study).
• Glaucoma or history of ocular hypertension (intraocular pressures greater than 21 mm Hg).
• Cognitive or psychiatric disorders that may diminish compliance with study procedures, including maintenance of a daily pain diary and accurate dosing of study medication.
• Screening liver enzyme results greater than the upper limit of the normal range (a value less than one multiple above the upper limit of normal may be acceptable, if approved by the Sponsor before enrollment of the subject).
• Serum creatinine ≥ 2 mg/dL at screening
• Use of chemotherapy agents or history of cancer, other than non-metastatic skin cancer that has been completely excised, within five years prior to the screening visit.
• History of drug or alcohol abuse within one year prior to screening.
• Use within 2 weeks before start of study investigational compound dosing at baseline and through the end of the study of any investigational compound, any epidural or intrathecal agent, corticosteroid, antiretroviral, etanercept or other anti-TNF-α agent, topical anesthetics, or topical analgesics.

Sponsors & Collaborators

• Renovis: lead

Study Sites (16)

North Alabama Neuroscience Research Associates

Huntsville, Alabama, 35801, United States

Location

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

Advanced Clinical Therapeutics, LLC

Tuscon, Arizona, 85712, United States

Location

UCSD Center for Pain and Palliative Medicine

La Jolla, California, 92037, United States

Location

Neurophysiologic Laboratory

Laguna Hills, California, 92653, United States

Location

Colorado Neurology and Headache Center

Denver, Colorado, 80218, United States

Location

Palm Beach Neurological Center

Palm Beach Gardens, Florida, 33401, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33701, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Health Center, Dept. Anesthesiology

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

A and A Pain Institute

St Louis, Missouri, 63141, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Diagnostic Center of Houston

Houston, Texas, 77004, United States

Location

University of Wisconsin at Madison

Madison, Wisconsin, 53792, United States

Location

Related Links

• Click here for useful information on shingles

MeSH Terms

Conditions

Neuralgia; Herpes Zoster; Peripheral Nervous System Diseases; Neuralgia, Postherpetic; Hyperalgesia

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Somatosensory Disorders; Sensation Disorders

Study Officials

• Randall W Moreadith, MD, PhD

  Chief Medical Officer, Renovis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2004
• First Posted: December 16, 2004
• Study Start: August 1, 2003
• Study Completion: December 1, 2004
• Last Updated: July 29, 2010

Record last verified: 2005-03

Locations

US (16)