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Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)

NCT01733394 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-07-19

No results posted yet for this study

Summary

The United States Food and Drug Administration (FDA) has specific rules which generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of problems with the generic drugs.

This research is to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy.

The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.

Conditions

Interventions

DRUG

Lamotrigine Generic "A" Lamotrigine Generic "B" Lamotrigine "Brand"

DRUG

lamotrigine

Sponsors & Collaborators

Principal Investigators

  • Michael D. Privitera, MD · University of Cincinnati

  • Michel J Berg, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2016-09-26
Completion
2016-09-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733394 on ClinicalTrials.gov