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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02404168
Other study ID # HP-00063848
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 7, 2015
Est. completion date April 6, 2016

Study information

Verified date August 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date April 6, 2016
Est. primary completion date January 18, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
lamotrigine (brand Lamictal)
an anti-epileptic drug (brand)
lamotrigine (generic Teva)
an anti-epileptic drug (brand)

Locations

Country Name City State
United States University of Maryland Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (1)

Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007 Mar;48(3):464-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary AUC 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
Primary Cmax 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
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