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Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Information source: Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Facial Neuropathy

Intervention: Lamotrigine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pain and Analgesia Imaging and Neuroscience Group

Official(s) and/or principal investigator(s):
David Borsook, M.D., Ph.D., Principal Investigator, Affiliation: Mclean Hospital


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).

Clinical Details

Official title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome: subjective ratings of pain during MR scanning

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.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Locations and Contacts

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

P.A.I.N. Group article

Related 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.

Starting date: October 2005
Last updated: November 29, 2012

Page last updated: August 23, 2015

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