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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01413711
First Posted: August 10, 2011
Last Update Posted: September 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lundbeck LLC
June 17, 2011
August 10, 2011
September 13, 2012
June 2012
September 2013   (Final data collection date for primary outcome measure)
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 ]
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
Same as current
Complete list of historical versions of study NCT01413711 on ClinicalTrials.gov Archive Site
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 ]
Safety and tolerability parameters such as adverse events, clinical safety laboratory tests and vital signs will be summarised using descriptive statistics
Same as current
Not Provided
Not Provided
 
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Infantile Spasms
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®
Experimental: Vigabatrin
Intervention: Drug: Vigabatrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
1 Month to 6 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01413711
13453A
No
Not Provided
Not Provided
Lundbeck LLC
Lundbeck LLC
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
Lundbeck LLC
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP