Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00203229
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2005-09-13
Brief Title:
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Double-Blind Placebo Controlled Add-on Study to Determine the Efficacy and Safety of Lamictal Lamotrigine in Patients With Trigeminal Neuralgia Tic Doloureux
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study will look at the safety eg 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
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 randomized to the active medication group and nineteen to the placebo group Using a daily diary all patients will document their overall pain level and attack frequency and intensity for four weeks After the four week baseline period patients will initiate medication lamotrigine or placebo Patients will titrate until either they reach the maximum dose of 400mg per day and up to 700mg for patients on enzyme-inducing anti-epileptic drugs EIAEDs their side effects inhibit further increases known as maximum tolerated dose MTD or their trigeminal neuralgia pain resolves referred to as pain free dose PFD over eight weeks Patients will remain on a constant dose of prior medications throughout the study Patients will remain on maximum dose MTD or PFD for a maintenance period of at least eight weeks and at the end of the maintenance period patients who opt to stay on the medication will be unblinded as to medication and dosage Primary outcome will be average intensity of daily pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H92001 | OTHER_GRANT | GlaxoSmithKline | None |