Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia

Completed · Not applicable · Has a placebo group

Conditions studied: Trigeminal Neuralgia

In brief

This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.

Key facts

Study ID

NCT00203229

Run by

Thomas Jefferson University

People needed

20

Starts

2003-06-01

Expected to finish

2006-07-01

Last updated by the study team

2014-06-03

Who can join

Age: 15 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 - 75 yrs
• Male; or non-pregnant/non-lactating female
• Use of adequate birth-control measures as determined by investigator for females of child-bearing potential
• Diagnosis of trigeminal neuralgia (TN) using IHS (International Headache Society) criteria (see appendix A)
• Able to cooperate with and understand study instructions
• Signed informed consent prior to entering study
• Patients must be on a stable dose of concomitant medications for treatment of trigeminal neuralgia (TN) for at least 4 weeks (see below)
• If subject is currently receiving a tricyclic antidepressant, anticonvulsant, and/or Class I antiarrhythmic (e.g., amitriptyline, mexiletine, phenytoin, gabapentin or carbamazepine) for treatment of pain or any other condition, subject must be willing and able to maintain stable doses of these agents within 4 weeks prior to randomization and throughout the study (i.e., doses cannot be increased or decreased during this period).
• Subjects who require "rescue" analgesic medication during the study will be allowed to use increased doses of their current (pre-study) opioid and/or non opioid analgesics as clinically indicated (e.g., non-steroidal anti-inflammatory medications, acetaminophen, COX-2 inhibitors, topical analgesics). Subjects will be allowed to use a new analgesic for a limited time for non-neuropathic pain (e.g., headache, sinusitis, strained muscle, minor ache and pain), but will be prohibited from initiating therapy with a new analgesic agent and use it continuously throughout the remainder of the study.
• If subject is not currently receiving a tricyclic antidepressant, anticonvulsant, and/or Class I antiarrhythmic (e.g., amitriptyline, mexiletine, phenytoin, gabapentin or carbamazepine) for treatment of pain or any other condition, subject must be willing and able to abstain from initiation of these agents within 4 weeks prior to randomization and throughout the study.
• Subject must be willing and able to abstain from initiating an alternative therapy (e.g., acupuncture, massage or physical therapy) for pain relief during the study. (NOTE: subjects who are currently using alternative therapy for pain relief can be enrolled if they are willing and able to maintain such therapy stable throughout the study.)

You may not qualify if…

• Serious hepatic, respiratory, hematologic, cardiovascular or renal condition
• Neurologic pain other than TN (trigeminal neuralgia), with the exception of occasional migrainous/ tension-type headaches. (<4 headaches per month)
• Psychiatric or medical condition that might compromise participation in study, as determined by the investigator
• Use of opioid analgesic as treatment of neuralgia (>2 days per week)
• Administration of any investigational drug within 30 days prior to screening
• Concurrent use of sodium valproate
• Current diagnosis of active epilepsy or any active seizure disorder requiring chronic therapy with antiepileptic drug(s)
• Pregnant or breastfeeding women
• History of substance abuse/ alcoholism

Where it is running

• Jefferson Headache Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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