Trigeminal NeuralgiaPhase 2/3NCT00913107
Efficacy and Safety Study of Lamotrigine to Treat Trigeminal Neuralgia
A Phase 2/3 study testing Lamictal® and Tegretol® in people with Trigeminal Neuralgia, run by University of Malaya at 2 sites in Malaysia.
Trial summary
The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Lamictal® and Tegretol®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesMalaysia
- Study dates
- Sep 2007to Jun 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Dept. of OMOP, Faculty of Dentistry, University Malaya.
Kuala Lumpur, 50603
Dept. of Oral Medicine and Oral Pathology, Faculty of Dentistry, University Malaya.
Kuala Lumpur, 50603
About this study
Official title: Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine
The purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (TGN).
Read the 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.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Lamictal®, Tegretol®
- Keywords
- Trigeminal Neuralgia, Lamotrigine, Carbamazepine, Lamictal®, Tegretol®
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamictal®Drug
Also called Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)
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.
Tegretol®Drug
Also called Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for 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.
| Study group | Role | What they receive |
|---|---|---|
| Lamictal® | Experimental | Lamictal® was used as the "active" medication in this study. Receives: 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®. Receives: Drug: Lamictal®; Drug: Tegretol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-relief
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Investigators
- Dr. Sameer Shaikh, MDSc., Principal investigator, Faculty of Dentistry, University Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913107
- Sponsor's protocol ID
- PS287-2007B
- Status last verified
- Jun 2010
- First submitted
- 27 May 2009
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21621166
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lamotrigine in Trigeminal Neuralgia: Efficacy and Safety in Comparison With Carbamazepine
- ClinicalTrials.gov ID
- NCT00913107
- Acronym / sponsor ID
- PS287-2007B
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, Lamotrigine, Carbamazepine, Lamictal®, Tegretol®
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamictal® | Experimental | Drug: Lamictal®, Drug: Tegretol®Lamictal® was used as the "active" medication in this study. |
| Tegretol® | Active comparator | Drug: Lamictal®, Drug: 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®. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- psychiatric illness
- severe liver or cardiovascular disease
- renal impairment, low white cell count
- malignancy
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamictal®Also: Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for Tegretol®)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. | Drug | Lamictal®, Tegretol® |
| Tegretol®Also: Lamotrigine (generic name for Lamictal®), Carbamazepine (generic name for 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. | Drug | Lamictal®, Tegretol® |
Primary outcome
Pain-relief
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Derived from this study: PubMed 21621166Shaikh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sameer Shaikh, MDSc. principal investigator
Faculty of Dentistry, University Malaya
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lamictal® and Tegretol® in people with Trigeminal Neuralgia, run by University of Malaya at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-relief (time frame: 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00913107, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.