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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00545012
Other study ID # N164
Secondary ID
Status Completed
Phase Phase 2
First received October 15, 2007
Last updated September 16, 2013
Start date May 2000
Est. completion date May 2003

Study information

Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health Products
Study type Interventional

Clinical Trial Summary

This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date May 2003
Est. primary completion date May 2003
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria:

- Male/female 4-17 years old having participated in study N162 or in study N163

- suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE

- expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration

Exclusion Criteria:

- allergy/intolerance to pyrrolidine derivatives and/or excipients

- use of > 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Levetiracetam


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Outcome

Type Measure Description Time frame Safety issue
Primary Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam
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