Clinical Study of Lamotrigine to Treat Newly Diagnosed Epilepsy
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Lamictal (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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).
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.
Clinical Details
Official title: A Multi-center, Uncontrolled, Open-label, Evaluation of Lamotrigine Monotherapy in Newly Diagnosed Epilepsy or Recurrent Epilepsy (Currently Untreated)
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Secondary outcome: 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 the First Seizure in the Maintenance Phase (Across Seizure Types and by Seizure Type)
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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).
2. Subjects have a confident diagnosis of epilepsy uncomplicated by pseudoseizures
(psychogenic nonepileptic seizures).
3. Subjects have had at least 2 seizures in the previous 6 months with at least 1
seizure in the previous 3 months.
4. Age: ≥16 years (at the time of obtaining consent)
5. Outpatients
6. Subjects are able to write a seizure diary.
7. 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.
8. Gender: Male or female If female, and of childbearing potential, be using an
acceptable form of birth control.
9. 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.
10. Subjects are able to comply with dosing of investigational products and all study
procedures.
Exclusion Criteria:
1. 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.
2. Subjects with a history of treatment with AEDs (≥2 weeks) during 6 months before the
start of treatment with the investigational product.
3. Subjects with a history of treatment with lamotrigine.
4. Subjects with a history of rash associated with other AED treatment.
5. 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.
6. 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.
7. Subjects with a severe psychiatric disorder which affects the procedure of study or
drug assessment.
8. Subjects with an acute or progressive neurological disorder or an organic disease.
9. 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.
10. 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).
11. Female subjects who are pregnant or lactating, who may be pregnant, or who plan for
pregnancy during the study.
12. Subjects taking inducers of lamotrigine glucuronidation (i. e., rifampicin,
lopinavir/ritonavir), atazanavir/ritonavir, risperidone, oral contraceptives or
hormone drug which includes estrogen.
13. Subjects having participated in other clinical study within 3 months before the start
of investigational product.
14. 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.
15. Subjects whom the investigator or subinvestigator considers ineligible for the study.
Locations and Contacts
GSK Investigational Site, Fukuoka 807-8555, Japan
GSK Investigational Site, Ibaraki 317-0077, Japan
GSK Investigational Site, Kagoshima 892-0844, Japan
GSK Investigational Site, Kyoto 611-0042, Japan
GSK Investigational Site, Miyagi 980-8574, Japan
GSK Investigational Site, Nara 634-8522, Japan
GSK Investigational Site, Niigata 950-1197, Japan
GSK Investigational Site, Niigata 950-2085, Japan
GSK Investigational Site, Okayama 703-8265, Japan
GSK Investigational Site, Osaka 560-8565, Japan
GSK Investigational Site, Shizuoka 430-8558, Japan
GSK Investigational Site, Seoul 110-744, Korea, Republic of
GSK Investigational Site, Seoul 135-710, Korea, Republic of
Additional Information
Starting date: September 2011
Last updated: May 11, 2015
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