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

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.

Study Overview

• Status: Withdrawn
• Conditions: Infantile Spasms
• Intervention / Treatment: Drug: Vigabatrin

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Sabril®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age)	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	24 hrs post dose on Day 1 and 12 hrs post dose on Day 5

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lundbeck LLC

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: June 17, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2012
• Last Update Submitted That Met QC Criteria: September 12, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacokinetics; IS; Area under the curve; Maximum plasma concentration; Time to maximum concentration
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epileptic Syndromes; Neurologic Manifestations; Neuromuscular Manifestations; Epilepsy; Spasms, Infantile; Spasm; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; GABA Agents; Anticonvulsants; Vigabatrin
• Other Study ID Numbers: 13453A