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

NCT02404168 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HP-00063848
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

lamotrigine brand tablet1

ACTIVE COMPARATOR

lamotrigine tablet Lamictal

Drug: lamotrigine (brand Lamictal)

lamotrigine generic tablet1

EXPERIMENTAL

lamotrigine tablet Teva

Drug: lamotrigine (generic Teva)

lamotrigine brand tablet2

ACTIVE COMPARATOR

lamotrigine tablet Lamictal

Drug: lamotrigine (brand Lamictal)

lamotrigine generic tablet2

EXPERIMENTAL

lamotrigine tablet Teva

Drug: lamotrigine (generic Teva)

Interventions

lamotrigine (brand Lamictal) DRUG

an anti-epileptic drug (brand)

Also known as: Lamictal

lamotrigine brand tablet1; lamotrigine brand tablet2

lamotrigine (generic Teva) DRUG

an anti-epileptic drug (brand)

Also known as: generic lamotrigine

lamotrigine generic tablet1; lamotrigine generic tablet2

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Related 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. doi: 10.1111/j.1528-1167.2007.01007.x.

  PMID: 17346246 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This was a small study.

Results Point of Contact

• Title: James Polli
• Organization: University of Maryland

jpolli@rx.umaryland.edu

410-706-8292

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: March 31, 2015
• Study Start: July 7, 2015
• Primary Completion: January 18, 2016
• Study Completion: April 6, 2016
• Last Updated: August 19, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-08

Locations

US (1)