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

NCT01413711 | Withdrawn Phase 4

• 1 other identifier: 13453A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infantile Spasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine the safety of vigabatrin following oral dose administrations in infants (>=1 and <6 months of age)

  Safety collected throughout the 5-day study

Study Arms (1)

Vigabatrin

EXPERIMENTAL

Drug: Vigabatrin

Interventions

Vigabatrin DRUG

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

Also known as: Sabril®

Vigabatrin

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundbeck LLC: lead

MeSH Terms

Conditions

Spasms, Infantile

Interventions

Vigabatrin

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: August 10, 2011
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Last Updated: September 13, 2012

Record last verified: 2012-09