Overview

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

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
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 adults with trigeminal neuralgia.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Thomas Jefferson University
Treatments:
Anticonvulsants
Lamotrigine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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