NCT00243152|CompletedResults
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Sponsor study identifier
interventional
6
1 country
1
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
October 19, 2005
Actual (reported)October 21, 2005
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)December 7, 2018
Actual (reported)Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
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\*\* Cortical, subcortical, and brain stem sensory regions Z-scores Increase or decrease in activation as affected by the drug
Week 10 during scanning session
Subjective Ratings of Pain During Magnetic Resonance Scanning
week 10 (during the scan)
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.
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.
: 25mg and 50mg tablets
Sugar pill manufactured to mimic Lamotrigine tablets
McLean Hospital Neuroimaging Center, 115 Mill Street
Belmont, Massachusetts, 02478, United States
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.
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.
Every effort was made to obtain the data presented in outcome measure 2. However only the data in the publication is available, estimates were made based on the figures.
David Borsook, M.D., Ph.D.
Mclean Hospital
6 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
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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.
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.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
December 7, 2018
Results First Posted
December 7, 2018
Record last verified: 2018-12
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Source: ClinicalTrials.gov.
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