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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine to Placebo Crossover | Active Comparator | 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. |
|
| Placebo to Lamotrigine Crossover | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | : 25mg and 50mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings of Pain During Magnetic Resonance Scanning | Quantitative Sensory Testing (QST) Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Borsook, M.D., Ph.D. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital Neuroimaging Center, 115 Mill Street | Belmont | Massachusetts | 02478 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11738036 | Background | 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. | |
| 9415509 | Background | 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. |
| Label | URL |
|---|---|
| P.A.I.N. Group article | View source |
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This study recruited adult males and females ages 18 to 60 with diagnosed facial neuropathic pain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lamotrigine to Placebo Crossover | The drug lamotrigine taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period 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. Lamotrigine: : 25mg and 50mg tablets |
| FG001 | Placebo to Lamotrigine Crossover | Placebo is taken 9 weeks prior to imaging session 1. A rescue drug, Gabapentin, provided during both arms of the study for pain control. Patients taper off the Gabapentin 2 weeks before each scan date. After a taper and washout period 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Both male and female adults ages 18 to 60 years old who are right-handed and non-smokers. Participants must be diagnosed with facial pain that has been continuous for more than 3 months. Their spontaneous pain must be great than 3 of 10 and their allodynia to brush must be greater than 5 of 10.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Lamotrigine: : 25mg and 50mg tablets |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The data's primary comparisons no longer exists per intervention. | Posted | Number | Z-statistic | Week 10 during scanning session |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lamotrigine | The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. 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. Lamotrigine: : 25mg and 50mg tablets |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Borsook | Boston Children's Hospital | 617-281-7135 | david.borsook@childrens.harvard.edu |
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| ID | Term |
|---|---|
| D005155 | Facial Nerve Diseases |
| D010146 | Pain |
| D019066 | Facies |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| C050016 | lipoarabinomannan |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo (for Lamotrigine) | Drug | Sugar pill manufactured to mimic Lamotrigine tablets |
|
|
| week 10 (during the scan) |
| 14622682 | Background | 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. |
| 20492571 | Result | 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. |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosed with facial pain | Number | participants |
|
| Continuous pain for more than 3 months | Number | participants |
|
| Spontaneous pain greater than 3 of 10 | Pain Scale Description: 0-10 rating scale where 0 indicates no pain and 10 indicates the highest pain | Number | participants |
|
| Allodynia brush greater than 5 of 10 | Pain Scale Description: 0-10 rating scale where 0 indicates no pain and 10 indicates the highest pain | Number | participants |
|
| Right-handed | Number | participants |
|
| Non-smokers | Number | participants |
|
The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Placebo will be administered in another imaging session. 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.
|
|
| Secondary | Subjective Ratings of Pain During Magnetic Resonance Scanning | Quantitative Sensory Testing (QST) Stimuli Type: Heat, Cold, Brush Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Cold, threshold -1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Stimuli Type: Heat, threshold +1°C Stimulation Regions: Face Affected and contralateral Unaffected mirror area Rating: Pain/ unpleasantness Ratings on a likert scale of 0-10 with 0 being defined as no pain and 10 being defined as worst possible pain | Posted | Mean | Standard Deviation | scores on a pain scale | week 10 (during the scan) |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | The placebo will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. 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. Placebo (for Lamotrigine): Sugar pill manufactured to mimic Lamotrigine tablets | 0 | 6 | 0 | 6 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Cold Affected |
|
| Cold Unaffected |
|
| Brush Affected |
|
| Brush Unaffected |
|
| t-test, 2 sided |
| >0.05 |
| Superiority |
| VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the affected side. | t-test, 2 sided | >0.05 | Superiority |
| VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for cold applied to the unaffected side. | t-test, 2 sided | >0.05 | Superiority |
| VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the affected side. | t-test, 2 sided | >0.05 | Superiority |
| VAS rating in the scanner. Measures of pain rating to evoke stimuli during scanning for brush applied to the unaffected side. | t-test, 2 sided | >0.05 | Superiority |