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Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

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ClinicalTrials.gov Identifier: NCT00243152
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : November 30, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group

Brief Summary:
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 or disease Intervention/treatment Phase
Facial Neuropathy Drug: Lamotrigine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Study Start Date : October 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Lamotrigine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lamotrigine
The drug lamotrigine or placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided during both arms of the study for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period lamotrigine or placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug/placebo will be given. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.
Drug: Lamotrigine
: 25mg and 50mg tablets
Other Names:
  • LAMO
  • LAM



Primary Outcome Measures :
  1. blood oxygenation level-dependent (BOLD) changes in neural pain circuitry following treatment with lamotrigine during experimentally induced pain states [ Time Frame: 75-90 (mins relative to start) Anatomical Scan, 90-150 fMRI ]
    fMRI scans acquired Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness fMRI scans acquired Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning** fMRI scans acquired Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness **Extra time allotted for probe repositioning**


Secondary Outcome Measures :
  1. subjective ratings of pain during MR scanning [ Time Frame: 65-75- Quantitative Sensory Testing, 105-110, 125-130, 145-150 (minutes relative to start) ]

    QST (Quantitative Sensory Testing) Thresholds

    Stimuli Type: Brush Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face (V2) Right and Left Sides Rating: Pain/ unpleasantness




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: David Borsook, M.D., Ph.D., Dr., Pain and Analgesia Imaging and Neuroscience Group
ClinicalTrials.gov Identifier: NCT00243152     History of Changes
Other Study ID Numbers: Facial Neuropathy/lamotrigine
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by David Borsook, M.D., Ph.D., Pain and Analgesia Imaging and Neuroscience Group:
pain
neuropathic
face
trigeminal

Additional relevant MeSH terms:
Facies
Facial Pain
Facial Nerve Diseases
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers