An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms - Full Text View

Purpose

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.

Condition	Intervention	Phase
Infantile Spasms	Drug: Vigabatrin	Phase 4


Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy X-linked infantile spasm syndrome

Drug Information available for: Vigabatrin

Genetic and Rare Diseases Information Center resources: West Syndrome

U.S. FDA Resources

Further study details as provided by Lundbeck LLC:

Primary Outcome Measures:

Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age) [ Time Frame: 24 hrs post dose on Day 1 and 12 hrs post dose on Day 5 ] [ Designated as safety issue: Yes ]
Serial blood for plasma generation will be collected on Days 1 and 5 and vigabatrin concenrations determined to the determine the pharmacokinetic profile of vigabatrin

Secondary Outcome Measures:

To determine the safety of vigabatrin following oral dose administrations in infants (>=1 and <6 months of age) [ Time Frame: Safety collected throughout the 5-day study ] [ Designated as safety issue: Yes ]
Safety and tolerability parameters such as adverse events, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics


Enrollment:	0
Study Start Date:	June 2012
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vigabatrin	Drug: Vigabatrin Oral vigabatrin as a single 25 mg/kg dose on Days 1 and 5, 25 mg/kg twice a day (50 mg/kg daily dose, orally) on Days 2-4 Other Name: Sabril®

Eligibility


Ages Eligible for Study:	1 Month to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient's parent or legally authorized representative is able to read and understand the Patient Information Sheet and Informed Consent Form.
The patient's legally authorized representative has signed the Informed Consent Form.
The patient has IS, diagnosed according to the International League Against Epilepsy (ILAE) criteria.
The patient is a full term (38 weeks gestation) male or female, aged >=1 month to <6 months at the time of enrollment.
The patient's length and body weight for gestational age is >=5th and <=95th percentile, according to Centers for Disease Control and Prevention (CDC) Growth Charts.

Exclusion Criteria:

The patient is currently being treated or has been previously treated with vigabatrin.
The patient is a member of the site personnel's immediate family.
The patient takes or has taken disallowed recent or concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the investigational medicinal product (IMP) or the excipients (povodone/iodine) of the IMP.
The patient has any other disorder for which the treatment takes priority over treatment of IS or is likely to interfere with study treatment or impair treatment compliance.
The patient has been treated with any IMP within 30 days or 5 half lives (whichever is longer) prior to the Screening Visit.
The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
The patient has been diagnosed or is judged by the investigator to have anemia.
The patient has been diagnosed or is judged by the investigator to have renal insufficiency.
The patient's parent or legally authorized representative is, in the investigator's opinion, unlikely or unwilling to comply with the protocol or the patient is unsuitable for any reason.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01413711

Sponsors and Collaborators

Lundbeck LLC

Investigators


Study Director:	Email contact via H. Lundbeck A/S	LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided


Responsible Party:	Lundbeck LLC
ClinicalTrials.gov Identifier:	NCT01413711 History of Changes
Other Study ID Numbers:	13453A
Study First Received:	June 17, 2011
Last Updated:	September 12, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lundbeck LLC:


IS Pharmacokinetics Area under the curve Maximum plasma concentration Time to maximum concentration

Additional relevant MeSH terms:


Spasms, Infantile Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Nervous System Diseases Vigabatrin Anticonvulsants	Central Nervous System Agents Enzyme Inhibitors GABA Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015