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Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

Information source: University of Malaya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Trigeminal Neuralgia

Intervention: Lamictal® (Drug); Tegretol® (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University of Malaya

Official(s) and/or principal investigator(s):
Dr. Sameer Shaikh, MDSc., Principal Investigator, Affiliation: Faculty of Dentistry, University Malaya


The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).

Clinical Details

Official title: Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Pain-relief

Detailed description: Trigeminal Neuralgia (TGN) is a rare form of chronic facial pain shrouded in mystery, although not life threatening, can be excruciating painful and extraordinarily debilitating. Its uniqueness and peculiarity can be ascertained by the fact that TGN may present to and be managed by dentists, neurologists, neurosurgeons, oral surgeons and ear, nose and throat surgeons. The management of TGN is initially medical, with the "gold standard" drug of carbamazepine (CBZ). Whilst CBZ continues to be the treatment of choice, a substantial proportion of patients tolerate this drug poorly, predominantly because of side-effects that include drowsiness, accommodation disorders, hepatitis, elevation in liver enzymes, renal dysfunction, congestive heart failure, delayed multi-organ failure, leucopenia, thrombocytopenia etc. etc. If pain-relief is incomplete with CBZ or it produces adverse side-effects, options include using an alternative second-line medical agent. The drugs suggested to be considered as second-line agents for the treatment of TGN, include: lamotrigine, baclofen, phenytoin, oxcarbazepine, gabapentin, clonazepam, valproate, mexiletine, and topiramate. Lamotrigine (LTG), a novel anticonvulsant, which has not been adequately assessed for its antineuralgic properties. It has a bimodal mechanism of action:

- inhibits the release of glutamate and aspartate by blocking voltage-sensitive sodium


- antagonistic at neuroexcitatory N-methyl-d-aspartate receptors.

It can also acts at and inhibits calcium channels to enhance the gamma- Aminobutyric acid (GABA) synthesis. GABA is an inhibitory amino acid neurotransmitter that decreases neural membrane action potentials and therefore decreases nerve excitability. Glutamate has been implicated in the mechanisms contributing towards phenomenon of chronic pain, such as sensitisation and wind up. LTG through its inhibition of pathological release of glutamate, has the potential towards management of chronic pain, particularly of neuropathic origin. Lamotrigine, therefore has the potential to be a promising new treatment for TGN.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of Trigeminal Neuralgia

- Male; or non-pregnant/non-lactating female

- Must be willing to cooperate with and understands study instructions

- Signed informed consent prior to entering study

Exclusion Criteria:

- psychiatric illness

- severe liver or cardiovascular disease

- renal impairment, low white cell count

- malignancy

- pregnancy or lactation

- alcohol or recreational drug abuse

- and positive tests for human immunodeficiency virus or hepatitis B or C.

Locations and Contacts

Dept. of OMOP, Faculty of Dentistry, University Malaya., Kuala Lumpur 50603, Malaysia

Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya., Kuala Lumpur 50603, Malaysia

Additional Information

Starting date: September 2007
Last updated: June 27, 2010

Page last updated: August 23, 2015

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