Status:
COMPLETED
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
Lead Sponsor:
Thomas Jefferson University
Conditions:
Trigeminal Neuralgia
Eligibility:
All Genders
15-75 years
Phase:
NA
Brief Summary
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 adult...
Detailed Description
A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled; nineteen will be randomi...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00203229
Start Date
June 1 2003
End Date
July 1 2006
Last Update
June 3 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107