Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

Overview[ - collapse ][ - ]

Purpose The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).
ConditionTrigeminal Neuralgia
InterventionDrug: Lamictal®
Drug: Tegretol®
PhasePhase 2/Phase 3
SponsorUniversity of Malaya
Responsible PartyUniversity of Malaya
ClinicalTrials.gov IdentifierNCT00913107
First ReceivedMay 27, 2009
Last UpdatedJune 27, 2010
Last verifiedJune 2010

Tracking Information[ + expand ][ + ]

First Received DateMay 27, 2009
Last Updated DateJune 27, 2010
Start DateSeptember 2007
Estimated Primary Completion DateJune 2008
Current Primary Outcome MeasuresPain-relief [Time Frame: 3-6 months] [Designated as safety issue: Yes]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
Official TitleLamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine
Brief Summary
The purpose of this study was to determine the efficacy and safety of lamotrigine in
patients with trigeminal neuralgia (TGN).
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.
Study TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
ConditionTrigeminal Neuralgia
InterventionDrug: 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.
Other Names:
  • Lamotrigine (generic name for Lamictal®)
  • Carbamazepine (generic name for Tegretol®)
Drug: 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.
Other Names:
  • Lamotrigine (generic name for Lamictal®)
  • Carbamazepine (generic name for Tegretol®)
Study Arm (s)
  • Experimental: Lamictal®
    Lamictal® was used as the "active" medication in this study.
  • Active Comparator: Tegretol®
    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®.

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment21
Estimated Completion DateJune 2008
Estimated Primary Completion DateFebruary 2008
Eligibility 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.
GenderBoth
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesMalaysia

Administrative Information[ + expand ][ + ]

NCT Number NCT00913107
Other Study ID NumbersPS287-2007B
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Malaya
Study SponsorUniversity of Malaya
CollaboratorsNot Provided
Investigators Principal Investigator: Dr. Sameer Shaikh, MDSc. Faculty of Dentistry, University Malaya
Verification DateJune 2010

Locations[ + expand ][ + ]

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