Facial NeuropathyNCT00243152

Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI

A study testing Lamotrigine in people with Facial Neuropathy, run by Pain and Analgesia Imaging and Neuroscience Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Facial Neuropathy
What is being tested?: Lamotrigine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Jul 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Medications
Depression
Significant medical problems
Claustrophobia
Abnormal EKG
Significant drug or alcohol history

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

McLean Hospital Neuroimaging Center, 115 Mill Street
Belmont, Massachusetts, 02478

Other trials in United States

About this study

Read the 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
Being tested: Lamotrigine, Placebo (for Lamotrigine)
Keywords: pain, neuropathic, face, trigeminal
Medical subject headings: Facial Nerve Diseases, Pain, Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LamotrigineDrug
Also called LAMO, LAM
: 25mg and 50mg tablets
Placebo (for Lamotrigine)Drug
Also called Placebo
Sugar pill manufactured to mimic Lamotrigine tablets

Study groups in NCT00243152
Study group	Role	What they receive
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. Receives: Drug: Lamotrigine
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. Receives: Drug: Placebo (for Lamotrigine)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week 10 during scanning session

Secondary outcomes (1)

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
Measured: week 10 (during the scan)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Jul 2008

First posted21 Oct 2005 (estimated)
Study startOct 2005
Primary completionJul 2008
Study completionJul 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Facial NeuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00243152
Sponsor's protocol ID: Facial Neuropathy/lamotrigine
Status last verified: Dec 2018
First submitted: 19 Oct 2005
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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. doi: 10.1016/s0896-6273(01)00533-5.
PubMed 11738036
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.
PubMed 9415509
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.
PubMed 14622682
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.
PubMed 20492571

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Facial Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
ClinicalTrials.gov ID: NCT00243152
Acronym / sponsor ID: Facial Neuropathy/lamotrigine
Conditions: Facial Neuropathy
Keywords: pain, neuropathic, face, trigeminal
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Pain and Analgesia Imaging and Neuroscience GroupUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Oct 2005
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 21 Oct 2005 (estimated)
Results: Posted 7 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lamotrigine to Placebo Crossover	Active comparator	Drug: LamotrigineThe 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	Drug: Placebo (for Lamotrigine)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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (13 listed)

Medications
Depression
Significant medical problems
Claustrophobia
Abnormal EKG

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LamotrigineAlso: LAMO, LAM: 25mg and 50mg tablets	Drug	Lamotrigine to Placebo Crossover
Placebo (for Lamotrigine)Also: PlaceboSugar pill manufactured to mimic Lamotrigine tablets	Drug	Placebo to Lamotrigine Crossover

Primary outcome

Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States
Time frame: Week 10 during scanning session
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

1 secondary outcome

Subjective Ratings of Pain During Magnetic Resonance Scanning
Time frame: week 10 (during the scan)

Results and safety

Results posted to the registry on 7 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lamotrigine to Placebo Crossover	3	3
Placebo to Lamotrigine Crossover	3	3

Primary outcome: Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States

Time frame: Week 10 during scanning session. Number. Unit: Z-statistic

Measure	Lamotrigine vs Placebo n = 6
Heat Affected Thalamus (10,-14,8)	-2.9294
Heat Affected Post-Central (-56,-12,28)	-2.7323
Cold Affected Post-Central (68, -8, 32)	-2.5114
Cold Affected Thalamus (-4, -8, 0)	-3.033
Brush Affected Post-Central (66,-16,14)	3.905
Brush Affected Thalamus (-14,-22, 4)	-3.791
Brush Affected Spinal Trigeminal Nucles(2,-48,-68)	2.9058

Population analysed: The data's primary comparisons no longer exists per intervention.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lamotrigine	0 of 6 (0%)	0 of 6 (0%)	Not reported
Placebo	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11738036Becerra 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.
Background: PubMed 9415509Zakrzewska 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.
Background: PubMed 14622682Petersen 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.
Results publication: PubMed 20492571Scrivani 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.
P.A.I.N. Group articleLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Borsook, M.D., Ph.D. principal investigator

Mclean Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lamotrigine in people with Facial Neuropathy, run by Pain and Analgesia Imaging and Neuroscience Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Oxygenation Level-dependent (BOLD) Changes in Neural Pain Circuitry Following Treatment With Lamotrigine During Experimentally Induced Pain States (time frame: Week 10 during scanning session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00243152, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.