Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI - Full Text View

Sponsor:	Pain and Analgesia Imaging and Neuroscience Group
Collaborator:	GlaxoSmithKline
Information provided by:	Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov Identifier:	NCT00243152

Purpose

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
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

Resource links provided by NLM:

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by Pain and Analgesia Imaging and Neuroscience Group:

Primary Outcome Measures:

blood oxygenation level-dependent (BOLD) changes in neural pain circuitry following treatment with lamotrigine during experimentally induced pain states

Secondary Outcome Measures:

subjective ratings of pain during MR scanning

Estimated Enrollment:	20
Study Start Date:	October 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18-60 years of age
Right-handed non-smokers
Diagnosed with facial pain
Continuous pain for more than 3 months
Spontaneous pain greater than 3 of 10
Allodynia to brush greater than 5 of 10

Exclusion Criteria:

Medications
Depression
Significant medical problems
Claustrophobia
Abnormal EKG
Significant drug or alcohol history
Positive drug screen
Weight greater than 285 lbs
History of allergy to anticonvulsants
Tattoos with metallic ink on upper body
Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas
Exposure to shrapnel or metal filings
Other metallic surgical hardware

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243152

Locations

United States, Massachusetts
McLean Hospital Neuroimaging Center, 115 Mill Street
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Pain and Analgesia Imaging and Neuroscience Group

GlaxoSmithKline

Investigators

Principal Investigator:

David Borsook, M.D., Ph.D.

Mclean Hospital

More Information

Additional Information:

P.A.I.N. Group article This link exits the ClinicalTrials.gov site

Publications:

Becerra L, Breiter HC, Wise R, Gonzalez RG, Borsook D. Reward circuitry activation by noxious thermal stimuli. Neuron. 2001 Dec 6;32(5):927-46.

Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens EL. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997 Nov;73(2):223-30.

Petersen KL, Maloney A, Hoke F, Dahl JB, Rowbotham MC. A randomized study of the effect of oral lamotrigine and hydromorphone on pain and hyperalgesia following heat/capsaicin sensitization. J Pain. 2003 Sep;4(7):400-6.

Responsible Party:	McLean Hospital ( David Borsook )
Study ID Numbers:	Facial Neuropathy/lamotrigine
Study First Received:	October 19, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00243152 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain and Analgesia Imaging and Neuroscience Group:

pain
neuropathic
face
trigeminal

Additional relevant MeSH terms:

Disease Attributes
Molecular Mechanisms of Pharmacological Action
Facies
Facial Pain
Nervous System Diseases
Calcium Channel Blockers
Pain
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators

Signs and Symptoms
Pathologic Processes
Facial Nerve Diseases
Therapeutic Uses
Lamotrigine
Neurologic Manifestations
Cranial Nerve Diseases
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010