EpilepsyPhase 3NCT01431963
Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy
A Phase 3 study testing Lamictal in people with Epilepsy, run by GlaxoSmithKline at 13 sites in 2 countries.
Trial summary
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lamictal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Sep 2011to Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Target disease: Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having the following seizure types as classified by the International Classification of Seizures.
- Partial seizures (with or without secondarily generalisation)
- Generalized tonic-clonic seizures without focal onset, with or without myoclonus but without other generalized seizure type(s).
- Subjects have a confident diagnosis of epilepsy uncomplicated by pseudoseizures (psychogenic nonepileptic seizures).
- Subjects have had at least 2 seizures in the previous 6 months with at least 1 seizure in the previous 3 months.
- Age: ≥16 years (at the time of obtaining consent)
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- Outpatients
- Subjects are able to write a seizure diary.
- Subjects understand and sign written informed consent. If a subject is under 20 years at the time of obtaining consent, a subject and a legally acceptable representative (e.g., a parent or a custodian) sign written consent to participate in this study.
- Gender: Male or female If female, and of childbearing potential, be using an acceptable form of birth control.
- QTc<450 millisecond (msec) or <480msec for subjects with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period.
- Subjects are able to comply with dosing of investigational products and all study procedures.
Who cannot join
- Subjects having seizure types other than partial seizure or generalized tonic clonic seizures with or without myoclonus. Subjects having status epilepticus within the 6 months prior to the start of study treatment.
- Subjects with a history of treatment with AEDs (≥2 weeks) during 6 months before the start of treatment with the investigational product.
- Subjects with a history of treatment with lamotrigine.
- Subjects with a history of rash associated with other AED treatment.
- Subjects with a history of substance (including alcohol and drugs) dependence within 12 months before the start of investigational product or abuse within 1 month before the start of investigational product according to DSM-IV-TR.
- Subjects with an acute or chronic illness likely to impair drug absorption, distribution, metabolism or excretion or with any unstable physical symptoms likely to require hospitalization during participation in the study.
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- Subjects with a severe psychiatric disorder which affects the procedure of study or drug assessment.
- Subjects with an acute or progressive neurological disorder or an organic disease.
- Subjects with any clinically significant chronic cardiac, renal, or hepatic medical condition. Any patient with these conditions are excluded from the study even if these conditions are being controlled with chronic therapy.
- Subjects with an unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Female subjects who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study.
- Subjects taking inducers of lamotrigine glucuronidation (i.e., rifampicin, lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or hormone drug which includes estrogen.
- Subjects having participated in other clinical study within 3 months before the start of investigational product.
- Subjects who have active suicidal plan/intent or have had active suicidal thoughts in the past 3 months before the start of investigational product or who have history of suicide attempt in the last 1 year before the start of investigational product or more than 1 lifetime suicide attempt.
- Subjects whom the investigator or subinvestigator considers ineligible for the study.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Japan11 sites
GSK Investigational Site
Fukuoka, 807-8555
GSK Investigational Site
Ibaraki, 317-0077
GSK Investigational Site
Kagoshima, 892-0844
GSK Investigational Site
Kyoto, 611-0042
GSK Investigational Site
Miyagi, 980-8574
GSK Investigational Site
Nara, 634-8522
GSK Investigational Site
Niigata, 950-1197
GSK Investigational Site
Niigata, 950-2085
GSK Investigational Site
Okayama, 703-8265
GSK Investigational Site
Osaka, 560-8565
GSK Investigational Site
Shizuoka, 430-8558
South Korea2 sites
GSK Investigational Site
Seoul, 110-744
GSK Investigational Site
Seoul, 135-710
About this study
Official title: A Multi-center, Uncontrolled, Open-label, Evaluation of Lamotrigine Monotherapy in Newly Diagnosed Epilepsy or Recurrent Epilepsy (Currently Untreated)
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated).
The study is composed of baseline, escalation phase, maintenance phase, taper phase and post study examination. During the escalation phase, the investigational product is administered orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2 weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However, the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding 200 mg/day can be administered in two divided doses (in the morning and evening). After the completion of maintenance phase, Japanese subjects who have responded to lamotrigine without tolerability issues are eligible to enter an extension phase of the study if indicated, until either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV (Last Subject's Last Visit) of the maintenance phase, whichever is sooner.
- Conditions
- Epilepsy
- Being tested
- Lamictal
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamictalDrug
No comparison.
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | Experimental | No comparison. Receives: Drug: Lamictal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)
Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.
Measured: Weeks 7 to 30
Secondary outcomes (2)
Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)
Time to withdrawal is defined as the time from the start of treatment until withdrawal from the study. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures which affect only a small region of the brain, often the temporal lobes or hippocampi. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.
Measured: up to Week 30
Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)
The time to the first seizure in the Maintenance Phase is measured at the time the first seizure occurred in the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.
Measured: Weeks 7 to 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431963
- Sponsor's protocol ID
- 115376
- Status last verified
- Aug 2016
- First submitted
- 1 Sep 2011
- Last updated
- 20 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Uncontrolled, Open-label, Evaluation of Lamotrigine Monotherapy in Newly Diagnosed Epilepsy or Recurrent Epilepsy (Currently Untreated)
- ClinicalTrials.gov ID
- NCT01431963
- Acronym / sponsor ID
- 115376
- Conditions
- Epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Posted 3 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, uncontrolled, open-label study conducted in Japan and South Korea to evaluate the efficacy and safety of lamotrigine monotherapy in subjects with newly diagnosed epilepsy and those with recurrent epilepsy (currently untreated).
The study is composed of baseline, escalation phase, maintenance phase, taper phase and post study examination. During the escalation phase, the investigational product is administered orally at 25 mg/day for 2 weeks, then 50 mg/day for 2 weeks and finally 100 mg/day for 2 weeks. During the maintenance phase, 200 mg/day is administered orally for 24 weeks. However, the dose can be decreased to 100 mg/day if there are safety concerns. Also, if it is confirmed that the seizures cannot be controlled at the dose of 200 mg/day, the dose can be gradually increased up to 400 mg/day by 50-100 mg/day at intervals of at least 1 week. As a rule, lamotrigine should be administered once daily (in the evening), but the dose exceeding 200 mg/day can be administered in two divided doses (in the morning and evening). After the completion of maintenance phase, Japanese subjects who have responded to lamotrigine without tolerability issues are eligible to enter an extension phase of the study if indicated, until either approval of this indication (monotherapy in epilepsy) or after 24 months after LSLV (Last Subject's Last Visit) of the maintenance phase, whichever is sooner.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine | Experimental | Drug: LamictalNo comparison. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Target disease: Subjects with newly diagnosed epilepsy or recurrent epilepsy which is untreated, having the following seizure types as classified by the International Classification of Seizures.
- Subjects have a confident diagnosis of epilepsy uncomplicated by pseudoseizures (psychogenic nonepileptic seizures).
- Subjects have had at least 2 seizures in the previous 6 months with at least 1 seizure in the previous 3 months.
- Age: ≥16 years (at the time of obtaining consent)
- Outpatients
Key exclusion criteria (15 listed)
- Subjects having seizure types other than partial seizure or generalized tonic clonic seizures with or without myoclonus. Subjects having status epilepticus within the 6 months prior to the start of study treatment.
- Subjects with a history of treatment with AEDs (≥2 weeks) during 6 months before the start of treatment with the investigational product.
- Subjects with a history of treatment with lamotrigine.
- Subjects with a history of rash associated with other AED treatment.
- Subjects with a history of substance (including alcohol and drugs) dependence within 12 months before the start of investigational product or abuse within 1 month before the start of investigational product according to DSM-IV-TR.
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 |
|---|---|---|
| LamictalNo comparison. | Drug | Lamotrigine |
Primary outcome
Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study)
Time frame: Weeks 7 to 30
Participants were considered to be seizure free if they did not report any seizures during the Maintenance Phase. Seizure types are defined as: ALL=any type of seizure; A: simple partial seizures, B: complex partial seizures; C: partial seizures evolving to secondary generation seizures; D5: tonic-clonic seizures. Simple partial seizures are seizures that affect only a small region of the brain, often the temporal lobes or hippocampi. Complex partial seizures are epileptic seizures that are associated with bilateral cerebral hemisphere involvement and cause impairment of awareness or responsiveness. Partial seizures evolving to secondary generation seizures are seizures that start as partial seizures, then spread to include the entire brain. Tonic-clonic seizures are a type of generalized seizure that affects the entire brain.
2 secondary outcomes
Time to Withdrawal/Dropout From the Study (Across Seizure Types and by Seizure Type in Past 6 Months in the Escalation and Maintenance Phases)
Time frame: up to Week 30
Time to the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)
Time frame: Weeks 7 to 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamictal in people with Epilepsy, run by GlaxoSmithKline at 13 sites in 2 countries.
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 12 inclusion and 15 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan, South Korea. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 3 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Were Seizure Free in the Maintenance Phase (Across Seizure Types and by Seizure Type Within 6 Months Prior to the Start of the Study) (time frame: Weeks 7 to 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2016.