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Trial record 3 of 7 for:    "West Syndrome" | "GABA Agents"

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

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.
 
ClinicalTrials.gov Identifier: NCT01413711
Recruitment Status : Withdrawn
First Posted : August 10, 2011
Last Update Posted : September 13, 2012
Sponsor:
Information provided by (Responsible Party):
Lundbeck LLC

Tracking Information
First Submitted Date  ICMJE June 17, 2011
First Posted Date  ICMJE August 10, 2011
Last Update Posted Date September 13, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01413711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
Official Title  ICMJE An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Infantile Spasms
Intervention  ICMJE 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®
Study Arms  ICMJE Experimental: Vigabatrin
Intervention: Drug: Vigabatrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 12, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2011)
8
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01413711
Other Study ID Numbers  ICMJE 13453A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lundbeck LLC
Study Sponsor  ICMJE Lundbeck LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account Lundbeck LLC
Verification Date September 2012

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