- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404168
BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
August 15, 2019 updated by: James E Polli, University of Maryland, Baltimore
Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
The prior BEEP study involved patients being switched between brand and generic in a very structured manner.
Other secondary comparisons were also made (i.e.
any differences in adverse effects and seizure control).
Some subjects were more disparate than other, in terms of generic being similar to brand.
In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923.
LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from Teva) will be compared pharmacokinetically.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- University of Maryland
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is able to provide informed consent and was enrolled in previous BEEP study.
- Subject is male or female between 18 and 76 years of age inclusive.
- Subject has a diagnosis of epilepsy with simple partial seizures and/or complex partial seizures, with or without secondary generalization or primary generalized seizures
- Subject has been maintained on a stable dose regimen of anti-epileptic drugs (AEDs), including lamotrigine at 200mg, 400mg, or 600mg total daily dosage divided BID for at least 8 weeks prior to Visit 1 and during the screening period
- Subject is willing to be switched between brand and generic lamotrigine
- Subject is an acceptable candidate for venipuncture
- Subject is willing to stop all OTC medications for 24 hours prior to and during 12 hour study visits
Exclusion Criteria:
- Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device
- Subject has a history of status epilepticus within the 12 month period prior to Visit 1.
- Subject has any medical condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in the trial
- Subject has any psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this trial or confound the interpretation of the trial data
- Subject has known hypersensitivity to lamotrigine
- Subject has a medical condition that impacts drug absorption (e.g. gastric bypass surgery), including routine use (i.e.
daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function
- Subject has any history of alcohol or drug abuse within the previous two years
- Subject has acute or subacutely progressive CNS disease
- Subject has moderate or severe liver impairment as assessed by alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥5 times the upper limit of normal (ULN).
- Subject has moderate or severe renal impairment as assessed by creatinine clearance lower than 50mL/min, using the Cockcroft-Gault formula
- Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: condom with spermicide, diaphragm with spermicide, IUD without progesterone, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence
- Female subject is pregnant or nursing
- Female subject is using hormonal contraceptive precautions including progesterone-coated IUD
- Subjects is using hormonal replacement therapy
- Subject is unwilling or unable to maintain their approximate daily smoking use during the study
- Subject is using rifampin or other non-AED that strongly modulates lamotrigine levels
- addition to lamotrigine and/or vagus nerve stimulation and/or intermittent benzodiazepine use (e.g. lorazepam, diazepam, clonazepam), subject is taking more than two concomitant AEDs
- Subject is not willing or able to be adherent to study protocol (e.g. dosing of lamotrigine and any interacting comedication).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: lamotrigine brand tablet1
lamotrigine tablet Lamictal
|
an anti-epileptic drug (brand)
Other Names:
|
Experimental: lamotrigine generic tablet1
lamotrigine tablet Teva
|
an anti-epileptic drug (brand)
Other Names:
|
Active Comparator: lamotrigine brand tablet2
lamotrigine tablet Lamictal
|
an anti-epileptic drug (brand)
Other Names:
|
Experimental: lamotrigine generic tablet2
lamotrigine tablet Teva
|
an anti-epileptic drug (brand)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC
Time Frame: 0-12hr
|
pharmacokinetic exposure (ng*hr/ml).
Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
|
0-12hr
|
Cmax
Time Frame: 0-12hr
|
pharmacokinetic rate (ng/ml).
Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
|
0-12hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2015
Primary Completion (Actual)
January 18, 2016
Study Completion (Actual)
April 6, 2016
Study Registration Dates
First Submitted
March 17, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 31, 2015
Study Record Updates
Last Update Posted (Actual)
August 19, 2019
Last Update Submitted That Met QC Criteria
August 15, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Lamotrigine
- Anticonvulsants
Other Study ID Numbers
- HP-00063848
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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