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

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Brief Title

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

Official Title

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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Non-compartmental pharmacokinetic profile of vigabatrin after oral administrations in infants(>=1 and <6 months of age)

Secondary Outcome

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

Condition

Infantile Spasms

Intervention

Vigabatrin

Study Arms / Comparison Groups

 Vigabatrin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

June 2012


Primary Completion Date

September 2013

Eligibility 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.
      

Gender

All

Ages

1 Month - 6 Months

Accepts Healthy Volunteers

No

Contacts

Email contact via H. Lundbeck A/S, , 



Administrative Informations


NCT ID

NCT01413711

Organization ID

13453A


Responsible Party

Sponsor

Study Sponsor

Lundbeck LLC


Study Sponsor

Email contact via H. Lundbeck A/S, Study Director, [email protected]


Verification Date

September 2012