|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
University of Rochester 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 |
|
Autoimmune Diseases Demyelinating Diseases Oxycodone Lidocaine Central Nervous System Depressants Anesthetics Narcotics Pain Sclerosis |
Cardiovascular Agents Anesthetics, Local Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Autoimmune Diseases of the Nervous System Analgesics, Opioid |
|
Oxycodone Physiological Effects of Drugs Anesthetics Pathologic Processes Multiple Sclerosis Sensory System Agents Therapeutic Uses Anti-Arrhythmia Agents Analgesics Autoimmune Diseases of the Nervous System Analgesics, Opioid Autoimmune Diseases Immune System Diseases |
Demyelinating Diseases Nervous System Diseases Lidocaine Central Nervous System Depressants Sclerosis Narcotics Cardiovascular Agents Anesthetics, Local Pharmacologic Actions Demyelinating Autoimmune Diseases, CNS Peripheral Nervous System Agents Central Nervous System Agents |