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| Sponsor: | University of Rochester |
|---|---|
| Collaborator: |
Endo Pharmaceuticals |
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00414453 |
Purpose
This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuropathic Pain Chronic Pain Multiple Sclerosis |
Drug: Lidocaine patch 5% Drug: Extended-release oxycodone Drug: Placebo extended-release oxycodone pills Drug: Placebo lidocaine patches |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Trial of Analgesia With Lidocaine or Extended-Release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis (TALENT-MS) |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Janet A Vaughan, MS, NP | 585-273-2445 | janet_vaughan@urmc.rochester.edu |
| Contact: Lisa M Bailey, RN | 585-275-3910 | lisa_bailey@urmc.rochester.edu |
| United States, New York | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Principal Investigator: | Robert H. Dworkin, PhD | University of Rochester School of Medicine and Dentistry |
More Information
| Study ID Numbers: | TALENT-MS |
| Study First Received: | December 19, 2006 |
| Last Updated: | February 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00414453 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neuropathic pain Chronic pain Multiple sclerosis Central neuropathic pain |
Peripheral neuropathic pain Opioid analgesic Lidocaine |
|
Oxycodone Physiological Effects of Drugs Anesthetics Pain Signs and Symptoms Pathologic Processes Multiple Sclerosis Neuromuscular Diseases Sensory System Agents Therapeutic Uses Analgesics Anti-Arrhythmia Agents Analgesics, Opioid Autoimmune Diseases of the Nervous System Autoimmune Diseases |
Immune System Diseases Demyelinating Diseases Neuralgia Nervous System Diseases Lidocaine Central Nervous System Depressants Narcotics Sclerosis Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Peripheral Nervous System Diseases Neurologic Manifestations Demyelinating Autoimmune Diseases, CNS Peripheral Nervous System Agents |