CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
lamotrigine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Age 18-75 years
  • Diagnosis of trigeminal neuralgia confirmed by IHS criteria
  • On stable dose of concomitant TN medications for at least 4 weeks before randomization
  • If currently on tricyclic antidepressant, anticonvulsant, or Class I antiarrhythmic, must maintain stable doses throughout study
Key exclusion· 7
  • Serious hepatic, respiratory, hematologic, cardiovascular, or renal condition
  • Neurologic pain other than TN (except occasional migrainous/tension-type headaches <4 per month)
  • Opioid analgesic use >2 days per week for neuralgia treatment
  • Concurrent use of sodium valproate

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00203229
NCT00203229N/ACompleted

A Double-Blind Placebo Controlled Add-on Study to Determine the Efficacy and Safety of Lamictal (Lamotrigine) in Patients With Trigeminal Neuralgia (Tic Doloureux)

Thomas Jefferson University·interventional·Posted Sep 20, 2005·Updated Jun 3, 2014

In Brief

A clinical study evaluating lamotrigine and Placebo for Trigeminal Neuralgia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJun 1, 2003
Primary CompletionMay 1, 2006
Study CompletionJul 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

lamotriginedrug

The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication.

Placebodrug

The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.