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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

Tracking Information
First Submitted Date  ICMJE May 27, 2009
First Posted Date  ICMJE June 3, 2009
Last Update Posted Date June 29, 2010
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2009)
Pain-relief [ Time Frame: 3-6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00913107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
Official Title  ICMJE Lamotrigine 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE
  • 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®)
Study Arms  ICMJE
  • Experimental: Lamictal®
    Lamictal® was used as the "active" medication in this study.
    Interventions:
    • Drug: Lamictal®
    • Drug: 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®.
    Interventions:
    • Drug: Lamictal®
    • Drug: Tegretol®
Publications * Shaikh S, Yaacob HB, Abd Rahman RB. Lamotrigine for trigeminal neuralgia: efficacy and safety in comparison with carbamazepine. J Chin Med Assoc. 2011 Jun;74(6):243-9. doi: 10.1016/j.jcma.2011.04.002. Epub 2011 May 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2009)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913107
Other Study ID Numbers  ICMJE PS287-2007B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sameer Shaikh, Dept. of OMOP, Faculty of Dentistry, University Malaya.
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Sameer Shaikh, MDSc. Faculty of Dentistry, University Malaya
PRS Account University of Malaya
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP