Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia

NCT00913107 | Completed Phase 2

• 1 other identifier: PS287-2007B
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Trigeminal Neuralgia

Keywords

Trigeminal Neuralgia; Lamotrigine; Carbamazepine; Lamictal®; Tegretol®

Outcome Measures

Primary Outcomes (1)

• Pain-relief

  3-6 months

Study Arms (2)

Lamictal®

EXPERIMENTAL

Lamictal® was used as the "active" medication in this study.

Drug: Lamictal®; Drug: Tegretol®

Tegretol®

ACTIVE COMPARATOR

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®; Drug: Tegretol®

Interventions

Lamictal® DRUG

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.

Also known as: Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)

Lamictal®; Tegretol®

Tegretol® DRUG

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.

Also known as: Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)

Lamictal®; Tegretol®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (2)

Dept. of OMOP, Faculty of Dentistry, University Malaya.

Kuala Lumpur, 50603, Malaysia

Location

Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 21621166 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Lamotrigine; Carbamazepine

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dr. Sameer Shaikh, MDSc.

  Faculty of Dentistry, University Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2009
• First Posted: June 3, 2009
• Study Start: September 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

MY (2)