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