Last updated: 11/04/2018 08:40:41
Conversion To Monotherapy With Lamictal Extended Release Tablets For Treatment Of Partial Epilepsy
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Trial description: This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
The percentage of participants in the 300 mg/day dose group who prematurely discontinued the study between Study Visit 5 (approximately week 7) and Visit 9 (end of the Treatment Phase)
Timeframe: From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23)
Secondary outcomes:
The percentage of participants in the 250 mg/day dose group who prematurely discontinued the study between Study Visit 5 (approximately week 7) and Visit 9 (end of the Treatment phase)
Timeframe: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Time to discontinuation in the Treatment phase
Timeframe: From Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Percentage of participants meeting Escape Criteria in the Treatment phase
Timeframe: Study Visit 5 through Visit 9 of the Treatment phase (approximately Week 7 through Week 23)
Percent change from Baseline in weekly seizure frequency between Study Visits 3 (start of dosing) and 9 (end of the Treatment phase)
Timeframe: Baseline and Study Visit 3 through Visit 9 of the Treatment phase (Treatment Week 0 through Week 23)
Number of seizure-free participants during the last 12 weeks of treatment of the Treatment phase
Timeframe: The last 12 weeks of treatment of the Treatment phase (Monotherapy phase - approximately Week 11 through Week 23)
Percent change from Baseline in the average seizure frequency measured at the end of participation in the Continuation phase
Timeframe: Baseline and start of Continuation phase through Week 24 or end of participation in the Continuation phase
The number of participants with at least the specified change in seizure frequency, compared to Baseline, at the end of participation in the Continuation phase (maximum of 24 weeks)
Timeframe: Baseline and entire Continuation phase (24 Weeks)
Interventions:
Enrollment:
226
Primary completion date:
2008-07-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
French JA, Hammer AE, Vuong A, Messenheimer JA.. Analysis of Three Lamotrigine Extended-Release Clinical Trials: Comparison of Pragmatic ITT and LOCF Methodologies. [Epilepsy Res]. 2012;101:141-147.
French, J., Temkin, N., Shneker, B., Hammer, A., Caldwell, P., Messenheimer, J.. Lamotrigine XR Conversion to Monotherapy: First Study Using a Historical Control Group . [Neurotherapeutics]. 2012;9(1):176-184.
Medical condition
Epilepsy, Partial
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
May 2006 to November 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
13+ years
Accepts healthy volunteers
No
- Inclusion criteria:
- Male or Female ≥13 years of age
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Male or Female ≥13 years of age
- Have a confident diagnosis of epilepsy with partial seizures for at least 24 weeks prior to the Baseline Phase
- Have a documented history of partial seizures such that the investigator must judge that the subject is likely to have at least 4 partial seizures during the 8-week Baseline Phase.
- Have experienced at least 4 partial seizures (i.e., simple or complex partial seizures with or without secondary generalization) during an 8-week (i.e., 56 days) prospective Baseline Phase with at least one partial seizure occurring during each 4-week (i.e., 28-day) period.
- NOTE: With prior authorization from GlaxoSmithKline (GSK), retrospective data may take the place of up to the first 4 weeks (i.e., first 28 days) of the Baseline Phase for subjects providing reliable documentation of the following: a)A complete daily seizure diary that includes the number, and type (i.e., simple or complex partial seizures with or without secondary generalization), of seizures experienced each day for up to 28 consecutive days immediately prior to the prospective Baseline Phase b)Stability of prescribed dosages of background antiepileptic drug (AED) c)Compliance with background AED All subjects permitted to use retrospective baseline data must complete a minimum of four weeks (i.e., 28 days) of the prospective Baseline Phase. The retrospective plus the prospective Baseline Phases must equal the 56 consecutive days prior to the start of dosing with study drug.
- be currently receiving AED monotherapy treatment with a stable regimen of a non-enzyme inducing AED for at least four weeks prior to starting the Baseline Phase.
- be able and willing to maintain an accurate, complete, written daily seizure diary, or has a parent/caregiver who is able and willing to maintain and accurate, complete, written daily seizure diary for the entire duration of the study.
- be able to comply with the dosing of study drugs, background AED, and all study procedures.
- understand and sign written informed consent, or will have a parent or a legally authorized representative who has done so, prior to the performance of any study assessments
- if female, and of childbearing potential be using an acceptable form of birth control, to include one of the following: a)Complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (a minimum of 2 weeks). b)Consistent and correct use of one of the following methods of birth control: Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject. Any intrauterine device (IUD) with a documented failure rate of less than 1% per year Double barrier method consisting of spermicide plus a mechanical barrier (e.g., spermicide plus a male condom or a female diaphragm). NOTE: Women who have had a hysterectomy, tubal ligation, or are post-menopausal are considered to be of non-childbearing potential. NOTE: A pharmacokinetic interaction has been observed between lamotrigine (LTG) and estrogen-based oral contraceptives. Therefore, the use of hormonal therapy (e.g., for contraception or hormone replacement therapy) is not allowed. Exclusion criteria:
- Exhibits any primary generalized seizures (e.g., absence, myoclonic primary generalized tonic-clonic seizures).
- Has had status epilepticus within the 24 weeks prior to, or during, the Baseline Phase.
- Is taking an enzyme-inducing AED (EIAED
- e.g. carbamazepine, phenytoin, phenobarbital, primidone) or is taking more than 1 background AED.
- Is currently taking lamotrigine (LTG) or has previously had an adequate trial of LTG.
- Is currently taking felbamate
- Is using hormone therapy
- Is abusing alcohol and/or other substances
- Has taken an investigational drug within the previous 30 days or plans to take an investigational drug anytime during the study.
- Is receiving chronic treatment with any medication that could influence seizure control
- NOTE: Use of benzodiazepines is allowed as specified in Section 8.1.2
- Is currently following the ketogenic diet.
- Is using vagal nerve stimulation
- Is planning surgery to control seizures during the study.
- Is pregnant, breastfeeding, or planning to become pregnant during the study or within the three weeks after the last dose of study drug.
- Is suffering from acute or progressive neurological disease, severe psychiatric disease or severe mental abnormality that is likely to interfere with the objectives of the study.
- Has any clinically significant cardiac, renal, hepatic condition, or a condition that affects the absorption, distribution, metabolism or excretion of drugs.
Trial location(s)
Location
GSK Investigational Site
Capital Fefderal, Buenos Aires, Argentina
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Minnesota, United States, 56303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mesa, Arizona, United States, 85201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Terminated/Withdrawn
Showing 1 - 6 of 98 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-07-11
Actual study completion date
2008-07-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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