Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
Primary Purpose
Trigeminal Neuralgia
Status
Completed
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Lamictal®
Tegretol®
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Trigeminal Neuralgia, Lamotrigine, Carbamazepine, Lamictal®, Tegretol®
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.
Sites / Locations
- Dept. of OMOP, Faculty of Dentistry, University Malaya.
- Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lamictal®
Tegretol®
Arm Description
Lamictal® was used as the "active" medication in this study.
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®.
Outcomes
Primary Outcome Measures
Pain-relief
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00913107
Brief Title
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
Official Title
Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Malaya
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia
Keywords
Trigeminal Neuralgia, Lamotrigine, Carbamazepine, Lamictal®, Tegretol®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lamictal®
Arm Type
Experimental
Arm Description
Lamictal® was used as the "active" medication in this study.
Arm Title
Tegretol®
Arm Type
Active Comparator
Arm Description
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®.
Intervention Type
Drug
Intervention Name(s)
Lamictal®
Other Intervention Name(s)
Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tegretol®
Other Intervention Name(s)
Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain-relief
Time Frame
3-6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sameer Shaikh, MDSc.
Organizational Affiliation
Faculty of Dentistry, University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of OMOP, Faculty of Dentistry, University Malaya.
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
21621166
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
We'll reach out to this number within 24 hrs