Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

University of Malaya

Status and phase: Completed; Phase 3; Phase 2

Conditions: Trigeminal Neuralgia

Treatments: Drug: Lamictal®; Drug: Tegretol®

Study type: Interventional

Funder types: Other

Identifiers

NCT00913107

PS287-2007B

Details and patient eligibility

About

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

Full 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 channels
• 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Lamictal®

Experimental group

Description:

Lamictal® was used as the "active" medication in this study.

Treatment:

Drug: Tegretol®

Drug: Lamictal®

Tegretol®

Active Comparator group

Description:

Tegretol® was employed as the "control" for comparative purposes in order to check and evaluate the efficacy (pain-relief) and occurrence of side- effects of Lamictal®.

Treatment:

Drug: Tegretol®

Drug: Lamictal®