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Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT00913107
Recruitment Status : Completed
First Posted : June 3, 2009
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
University of Malaya

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

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Lamictal® Drug: Tegretol® Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine
Study Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008


Arm Intervention/treatment
Experimental: Lamictal®
Lamictal® was used as the "active" medication in this study.
Drug: Lamictal®

The regime of prescription for Lamictal® during the clinical trials was as follows:

  1. 50 mg twice daily for 10days, followed by,
  2. 100 mg twice daily for the next 10days, followed by,
  3. 100 mg thrice daily for the next10 days, followed by,
  4. 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:

  1. 150 mg twice daily for 10days, followed by,
  2. 200 mg thrice daily for the next 10days, followed by,
  3. 300 mg thrice daily for the next 10 days, followed by,
  4. 300 mg four times daily for the final 10 days.
Other Names:
  • Lamotrigine (generic name for Lamictal®)
  • Carbamazepine (generic name for Tegretol®)
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®.
Drug: Lamictal®

The regime of prescription for Lamictal® during the clinical trials was as follows:

  1. 50 mg twice daily for 10days, followed by,
  2. 100 mg twice daily for the next 10days, followed by,
  3. 100 mg thrice daily for the next10 days, followed by,
  4. 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:

  1. 150 mg twice daily for 10days, followed by,
  2. 200 mg thrice daily for the next 10days, followed by,
  3. 300 mg thrice daily for the next 10 days, followed by,
  4. 300 mg four times daily for the final 10 days.
Other Names:
  • Lamotrigine (generic name for Lamictal®)
  • Carbamazepine (generic name for Tegretol®)



Primary Outcome Measures :
  1. Pain-relief [ Time Frame: 3-6 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913107


Locations
Malaysia
Dept. of OMOP, Faculty of Dentistry, University Malaya.
Kuala Lumpur, Malaysia, 50603
Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.
Kuala Lumpur, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
Principal Investigator: Dr. Sameer Shaikh, MDSc. Faculty of Dentistry, University Malaya

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Sameer Shaikh, Dept. of OMOP, Faculty of Dentistry, University Malaya.
ClinicalTrials.gov Identifier: NCT00913107     History of Changes
Other Study ID Numbers: PS287-2007B
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 29, 2010
Last Verified: June 2010

Keywords provided by University of Malaya:
Trigeminal Neuralgia
Lamotrigine
Carbamazepine
Lamictal®
Tegretol®

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Lamotrigine
Anticonvulsants
Carbamazepine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs