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| Sponsor: | Renovis |
|---|---|
| Information provided by: | Renovis |
| ClinicalTrials.gov Identifier: | NCT00099528 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Neuralgia Shingles Peripheral Nervous System Disease |
Drug: REN-1654 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | REN-1654 in Post-Herpetic Neuralgia: a Multi-Center, Placebo Controlled, 3-week Dose-Finding Study, With a 3-Week Active-Treatment Extension |
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | December 2004 |
This is a multi-center, double-blind, randomized, placebo-controlled, dose-finding study. After screening and baseline clinical assessments, subjects will be randomly assigned to receive 30 or 100 mg REN-1654 by mouth (p.o.), or matching placebo, once daily for 3 weeks. After 3 weeks of treatment, the clinical assessments will be repeated. Subjects who complete the 3 week placebo-controlled segment may enter the 3-week active-treatment extension segment, during which subjects in the REN-1654 30 mg group will remain on that dose, subjects who were given placebo in the previous segment will receive REN-1654 100 mg daily, and subjects who received REN 1654 100 mg in the first 3 week study segment will discontinue dosing. Double-blind conditions will be maintained through the placebo-controlled active treatment period (primary efficacy endpoint) and for those continuing dosing into the 3-week second active treatment period. The clinical assessments will be repeated at the end of 6 weeks, after which all subjects will discontinue treatment and return 2 weeks later for the final clinical assessment.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
Contacts and Locations| United States, Alabama | |
| North Alabama Neuroscience Research Associates | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pivotal Research Centers | |
| Peoria, Arizona, United States, 85381 | |
| HOPE Research Institute | |
| Phoenix, Arizona, United States, 85032 | |
| Advanced Clinical Therapeutics, LLC | |
| Tuscon, Arizona, United States, 85712 | |
| United States, California | |
| UCSD Center for Pain and Palliative Medicine | |
| La Jolla, California, United States, 92037 | |
| Neurophysiologic Laboratory | |
| Laguna Hills, California, United States, 92653 | |
| United States, Colorado | |
| Colorado Neurology and Headache Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Florida | |
| Palm Beach Neurological Center | |
| Palm Beach Gardens, Florida, United States, 33401 | |
| Suncoast Neuroscience Associates, Inc. | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Health Center, Dept. Anesthesiology | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Missouri | |
| A and A Pain Institute | |
| St. Louis, Missouri, United States, 63141 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, North Carolina | |
| The Center for Clinical Research | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Texas | |
| Diagnostic Center of Houston | |
| Houston, Texas, United States, 77004 | |
| United States, Wisconsin | |
| University of Wisconsin at Madison | |
| Madison, Wisconsin, United States, 53792 | |
| Study Director: | Randall W Moreadith, MD, PhD | Chief Medical Officer, Renovis, Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00099528 History of Changes |
| Other Study ID Numbers: | REN-1654-2-02 |
| Study First Received: | December 15, 2004 |
| Last Updated: | July 28, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Post-herpetic neuralgia Shingles Herpes Zoster Neuropathic pain Neuralgia |
Anti-TNF agents Inflammatory cytokines Hyperalgesia Allodynia Irritable nociceptor |
|
Herpes Zoster Nervous System Diseases Neuralgia Peripheral Nervous System Diseases Neuralgia, Postherpetic Herpesviridae Infections |
DNA Virus Infections Virus Diseases Pain Neurologic Manifestations Neuromuscular Diseases Signs and Symptoms |