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Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Seizures, Tonic-Clonic; Epilepsy, Tonic-Clonic

Intervention: lamotrigine (LAMICTAL) extended-release (Drug); Placebo (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 study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.

Clinical Details

Official title: A Multicenter, Double-Blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-release Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase

Secondary outcome:

Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase

Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase

Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase

Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase

Number of Participants With Improved Clinical Status on the Investigator's Global Assessment in the Double-Blind Treatment Phase

Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase

Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase

Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.

Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase

Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase

Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase

Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase

Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase

Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase

Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase

Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Is ≥13 years of age (male or female).

- Has a confident diagnosis of epilepsy with PGTC seizures for more than 24 weeks prior

to the Baseline Phase.

- Has electroencephalogram (EEG) evidence of either spike-and-wave discharges

consistent with PGTC, or at least 2 EEGs with no indication of focal abnormalities. The EEG may be historical or prospective. Investigators may use a historical EEG as long as there is appropriate documentation.

- Has a documented history of PGTC seizures with or without other generalized seizure

type(s) with no focal onset, and at least 1 PGTC seizure during the eight consecutive weeks (i. e., 56 consecutive days) prior to starting the 8-week Baseline Phase.

- Has at least 3 PGTC seizures occurring anytime during an 8-week (i. e., 56 days)

prospective Baseline Phase.

- NOTE: When a historical baseline is used, the same time period cannot count for

documentation of inclusion criteria 4 and 5. Additionally, innumerable seizure activity will not count towards the number of seizures required for randomization.

- NOTE: With authorization from GSK, a maximum of four weeks (i. e., 28 days) of

historical seizure data may replace up to four weeks (i. e., 28 days) of the prospective Baseline Phase for subjects providing reliable documentation of the following: 1. complete daily seizure diary that includes the number of seizures experienced each day along with the exact classification of each seizure type for consecutive days prior to the prospective Baseline Phase 2. stability of prescribed dosages of background antiepileptic drugs (AEDs) 3. compliance with background AEDs.

- All subjects permitted to use historical seizure data must complete a minimum of

four weeks (i. e., 28 days) of the prospective Baseline Phase. The historical Baseline Phase and the prospective Baseline Phase must equal 56 consecutive days.

- Is currently treated with a stable regimen of one or two AED(s) for at least four

weeks prior to starting the Baseline Phase (historical or prospective).

- NOTE: Benzodiazepines used chronically will be considered to be concurrent AEDs.

- NOTE: Subjects with surgically implanted vagal nerve stimulators (VNS) will be

allowed to enter the study provided that all of the following conditions are met: 1. VNS has been in place for at least 24 weeks prior to the Baseline Phase. 2. The settings must remain the same for at least 28 days prior to the Baseline Phase. 3. The settings must remain the same during the Baseline, Escalation, Maintenance and Transition Phases. 4. The battery is expected to last for the duration of the study. 5. VNS is counted as a "concurrent AED."

- Is able and willing to maintain an accurate and complete daily written seizure diary,

or has a parent/caregiver who is able and willing to maintain an accurate and complete daily written seizure diary for the entire duration of the study.

- Is able to comply with dosing of study drugs, background AEDs and all study

procedures.

- Has given written informed consent, or has a parent/legally authorized representative

who has given written informed consent, prior to the performance of any study assessments.

- If female, and of childbearing potential, must be using an acceptable form of birth

control, to include one of the following: 1. 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 3 weeks). 2. 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

- Implants of levonorgestrel

- Injectable progestogen

- Oral contraceptive (either combined, with at least 50mcg estrogen for women

on enzyme-induced AEDs, or progestogen only)

- 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. Exclusion Criteria:

- Has a history of partial seizures or interictal expression of partial seizures as

evidenced by EEG NOTE: EEG may be historical or prospective.

- Has had status epilepticus within the 24 weeks prior to, or during, the Baseline

Phase.

- Is taking three or more background AEDs chronically.

- Has Lennox-Gastaut syndrome.

- Is currently using or has previously used lamotrigine.

- Is currently taking felbamate.

- Is abusing alcohol and/or other substance(s).

- 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.

- Is currently following the ketogenic diet.

- Is planning surgery to control seizures during the study.

- Is suffering from acute or progressive neurological disease, severe psychiatric

disease, or severe mental abnormality that are 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.

- Is pregnant, breastfeeding, or planning to become pregnant during the study or within

the three weeks after the last dose of study drug.

Locations and Contacts

GSK Investigational Site, Ciudad Autonoma de Buenos Aires C1221ADC, Argentina

GSK Investigational Site, Ciudad Autónoma de Buenos Aires 1425, Argentina

GSK Investigational Site, Hyderabad, Andhra Pradesh 500482, India

GSK Investigational Site, Lucknow 226003, India

GSK Investigational Site, New Delhi, India

GSK Investigational Site, Seoul 135-710, Korea, Republic of

GSK Investigational Site, Kubang Kerian 16150, Malaysia

GSK Investigational Site, Ekaterinburg 620102, Russian Federation

GSK Investigational Site, Moscow 105066, Russian Federation

GSK Investigational Site, Moscow 107076, Russian Federation

GSK Investigational Site, Moscow 111539, Russian Federation

GSK Investigational Site, Moscow 117049, Russian Federation

GSK Investigational Site, Moscow 125412, Russian Federation

GSK Investigational Site, Samara 443095, Russian Federation

GSK Investigational Site, St'Petersburg 197136, Russian Federation

GSK Investigational Site, St.-Petersburg 193019, Russian Federation

GSK Investigational Site, St.-Petersburg 194291, Russian Federation

GSK Investigational Site, Kharkiv 61068, Ukraine

GSK Investigational Site, Kyiv 02660, Ukraine

GSK Investigational Site, Lviv 79021, Ukraine

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Alzenau, Bayern 63755, Germany

GSK Investigational Site, Bamberg, Bayern 96047, Germany

GSK Investigational Site, Capital Federal, Buenos Aires 1181, Argentina

GSK Investigational Site, Los Angeles, California 90033, United States

GSK Investigational Site, Santa Monica, California 90404, United States

GSK Investigational Site, Sepuldeva, California 91343, United States

GSK Investigational Site, Ocala, Florida 34471, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Savannah, Georgia 31405, United States

GSK Investigational Site, Suwanee, Georgia 30024, United States

GSK Investigational Site, Flossmoor, Illinois 60422, United States

GSK Investigational Site, Springfield, Illinois 62702, United States

GSK Investigational Site, Wichita, Kansas 67214, United States

GSK Investigational Site, Crestview Hills, Kentucky 41017, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, Boston, Massachusetts 02118, United States

GSK Investigational Site, Detroit, Michigan 48202, United States

GSK Investigational Site, Traverse City, Michigan 49684, United States

GSK Investigational Site, Minneapolis, Minnesota 55422, United States

GSK Investigational Site, Kansas City, Missouri 64111, United States

GSK Investigational Site, Las Vegas, Nevada 89106, United States

GSK Investigational Site, Edison, New Jersey 08818, United States

GSK Investigational Site, Hattingen, Nordrhein-Westfalen 45525, Germany

GSK Investigational Site, Koeln, Nordrhein-Westfalen 50767, Germany

GSK Investigational Site, Curitiba, Paraná 80069-900, Brazil

GSK Investigational Site, Limburgerhof, Rheinland-Pfalz 67117, Germany

GSK Investigational Site, Koethen, Sachsen-Anhalt 06366, Germany

GSK Investigational Site, Kiel, Schleswig-Holstein 24105, Germany

GSK Investigational Site, Dallas, Texas 75230, United States

GSK Investigational Site, Houston, Texas 77005, United States

GSK Investigational Site, Richmond, Virginia 23220, United States

Additional Information

Starting date: December 2004
Last updated: September 20, 2012

Page last updated: August 23, 2015

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