Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

NCT ID: NCT00243152

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2008-07-31

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).

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.

Conditions

Facial Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lamotrigine to Placebo Crossover

The drug lamotrigine will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, placebo (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for 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.

Group Type: ACTIVE_COMPARATOR

Lamotrigine

Intervention Type: DRUG

: 25mg and 50mg tablets

Placebo to Lamotrigine Crossover

The placebo will be given for 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. After a taper and washout, the drug lamotrigine (cross over) will be administered. At the end of the trial (after imaging session 2), a taper for drug 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.

Group Type: ACTIVE_COMPARATOR

Placebo (for Lamotrigine)

Intervention Type: DRUG

Sugar pill manufactured to mimic Lamotrigine tablets

Interventions

Lamotrigine

: 25mg and 50mg tablets

Intervention Type: DRUG

Placebo (for Lamotrigine)

Sugar pill manufactured to mimic Lamotrigine tablets

Intervention Type: DRUG

Other Intervention Names

LAMO; LAM; Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Pain and Analgesia Imaging and Neuroscience Group

OTHER

Sponsor Role: lead

Responsible Party

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

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital Neuroimaging Center, 115 Mill Street

Belmont, Massachusetts, United States

Countries

United States

References

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. doi: 10.1016/s0896-6273(01)00533-5.

Reference Type: BACKGROUND

PMID: 11738036 (View on PubMed)

Zakrzewska JM, Chaudhry Z, Nurmikko TJ, Patton DW, Mullens LE. Lamotrigine (lamictal) in refractory trigeminal neuralgia: results from a double-blind placebo controlled crossover trial. Pain. 1997 Nov;73(2):223-230. doi: 10.1016/S0304-3959(97)00104-8.

Reference Type: BACKGROUND

PMID: 9415509 (View on PubMed)

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. doi: 10.1016/s1526-5900(03)00718-1.

Reference Type: BACKGROUND

PMID: 14622682 (View on PubMed)

Scrivani S, Wallin D, Moulton EA, Cole S, Wasan AD, Lockerman L, Bajwa Z, Upadhyay J, Becerra L, Borsook D. A fMRI evaluation of lamotrigine for the treatment of trigeminal neuropathic pain: pilot study. Pain Med. 2010 Jun;11(6):920-41. doi: 10.1111/j.1526-4637.2010.00859.x. Epub 2010 May 11.

Reference Type: RESULT

PMID: 20492571 (View on PubMed)

Other Identifiers

Facial Neuropathy/lamotrigine

Identifier Type: -

Identifier Source: org_study_id