Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913107
• Other study ID #: PS287-2007B
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 27, 2009
• Last updated: June 27, 2010
• Start date: September 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2010
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Lamictal®
The regime of prescription for Lamictal® during the clinical trials was as follows: 50 mg twice daily for 10days, followed by, 100 mg twice daily for the next 10days, followed by, 100 mg thrice daily for the next10 days, followed by, 100 mg four times daily for the final 10 days.
• Tegretol®
The regime of prescription for Tegretol® during the clinical trials was as follows: 150 mg twice daily for 10days, followed by, 200 mg thrice daily for the next 10days, followed by, 300 mg thrice daily for the next 10 days, followed by, 300 mg four times daily for the final 10 days.

Locations

Country	Name	City	State
Malaysia	Dept. of OMOP, Faculty of Dentistry, University Malaya.	Kuala Lumpur
Malaysia	Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-relief		3-6 months	Yes