Trials / Withdrawn
WithdrawnNCT01413711
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Lundbeck LLC · Industry
- Sex
- All
- Age
- 1 Month – 6 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2013-09-01
- First posted
- 2011-08-10
- Last updated
- 2012-09-13
Source: ClinicalTrials.gov record NCT01413711. Inclusion in this directory is not an endorsement.