Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02404168
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
James E Polli, University of Maryland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: lamotrigine (brand Lamictal) Drug: lamotrigine (generic Teva) Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
Actual Study Start Date : July 7, 2015
Actual Primary Completion Date : January 18, 2016
Actual Study Completion Date : April 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Lamotrigine

Arm Intervention/treatment
Active Comparator: lamotrigine brand tablet1
lamotrigine tablet Lamictal
Drug: lamotrigine (brand Lamictal)
an anti-epileptic drug (brand)
Other Name: Lamictal

Experimental: lamotrigine generic tablet1
lamotrigine tablet Teva
Drug: lamotrigine (generic Teva)
an anti-epileptic drug (brand)
Other Name: generic lamotrigine

Active Comparator: lamotrigine brand tablet2
lamotrigine tablet Lamictal
Drug: lamotrigine (brand Lamictal)
an anti-epileptic drug (brand)
Other Name: Lamictal

Experimental: lamotrigine generic tablet2
lamotrigine tablet Teva
Drug: lamotrigine (generic Teva)
an anti-epileptic drug (brand)
Other Name: generic lamotrigine




Primary Outcome Measures :
  1. AUC [ Time Frame: 0-12hr ]
    pharmacokinetic exposure (ng*hr/ml)

  2. Cmax [ Time Frame: 0-12hr ]
    pharmacokinetic rate (ng/ml)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404168


Locations
Layout table for location information
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland

Publications:
Layout table for additonal information
Responsible Party: James E Polli, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT02404168     History of Changes
Other Study ID Numbers: HP-00063848
First Posted: March 31, 2015    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Lamotrigine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers