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Sponsors and Collaborators: |
Pain and Analgesia Imaging and Neuroscience Group GlaxoSmithKline |
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Information provided by: | Pain and Analgesia Imaging and Neuroscience Group |
ClinicalTrials.gov Identifier: | NCT00243152 |
The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic resonance imaging (fMRI).
Condition | Intervention |
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Facial Neuropathy |
Drug: lamotrigine: 25mg and 50mg tablets |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI |
Estimated Enrollment: | 20 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | September 2007 |
Currently there are no pharmacological agents that can control neuropathic pain akin to the efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have approximately the same efficacy of less than 30% in controlled trials, and many of these drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The trigeminal system in particular offers unique advantages for studying such alterations, including a large central representation and high degree of somatotopy. The administration of lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare subjective ratings of pain with objective measures of neural activity during increased conditions of allodynia/hyperalgesia.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sadie Cole, B.A. | 617-855-3156 | scole@mclean.harvard.edu |
Contact: Susie Morris, B.A. | 617-855-3852 | smorris@mclean.harvard.edu |
United States, Massachusetts | |
McLean Hospital Neuroimaging Center, 115 Mill Street | Recruiting |
Belmont, Massachusetts, United States, 02478 | |
Contact: Sadie Cole, B.A. 617-855-3156 scole@mclean.harvard.edu | |
Principal Investigator: David Borsook, M.D., Ph.D. |
Principal Investigator: | David Borsook, M.D., Ph.D. | Mclean Hospital |
Study ID Numbers: | Facial Neuropathy/lamotrigine |
Study First Received: | October 19, 2005 |
Last Updated: | September 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00243152 |
Health Authority: | United States: Institutional Review Board |
pain neuropathic face trigeminal |
Calcium, Dietary Signs and Symptoms Facies Facial Pain |
Facial Nerve Diseases Lamotrigine Neurologic Manifestations Pain |
Membrane Transport Modulators Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Nervous System Diseases |
Calcium Channel Blockers Cardiovascular Agents Cranial Nerve Diseases Central Nervous System Agents Anticonvulsants Pharmacologic Actions |