Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01413711
Other study ID # 13453A
Secondary ID
Status Withdrawn
Phase Phase 4
First received June 17, 2011
Last updated September 12, 2012
Start date June 2012

Study information

Verified date September 2012
Source Lundbeck LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 6 Months
Eligibility 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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lundbeck LLC

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Withdrawn NCT02299115 - Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms Phase 3
Completed NCT02885389 - Molecular Genetics in Infantile Spasms N/A
Completed NCT01006811 - Use of the Modified Atkins Diet in Infantile Spasms Phase 2/Phase 3
Completed NCT01828437 - Addition of Pyridoxine to Prednisolone in Infantile Spasms Phase 3
Recruiting NCT01858285 - Genetics of Epilepsy and Related Disorders
Completed NCT00552045 - Epilepsy Phenome/Genome Project
Completed NCT02220114 - Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy N/A
Completed NCT02954887 - Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7) Phase 3
Completed NCT02092883 - Evaluation of Neuroinflammation in Children With Infantile Spasms Phase 4
Completed NCT01723787 - Genetic Studies in Patients and Families With Infantile Spasms
Terminated NCT00442104 - Open-label Extension to Protocol 1042-0500 Phase 2
Completed NCT00441896 - A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms Phase 2
Completed NCT01575639 - Prednisolone in Infantile Spasms- High Dose Versus Usual Dose Phase 3
Withdrawn NCT01549288 - Trial of the Modified Atkins Diet in Infantile Spasms Refractory to Hormonal Therapy Phase 2/Phase 3
Not yet recruiting NCT06315829 - Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Completed NCT01073579 - Sabril Patient Registry N/A
Completed NCT02953548 - Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7) Phase 3
Completed NCT00001325 - Metabolic Abnormalities in Children With Epilepsy N/A
Completed NCT00968136 - Short-term Ketogenic Diet as Compared With Conventional Long-term Trial in Refractory Infantile Spasms: A Randomized, Controlled Study N/A