Status:
COMPLETED
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) c...
Eligibility Criteria
Inclusion
- Male/female adult subjects (≥ 16 or 18 years)
- Diagnosis of epilepsy (all types of seizures may be included)
- Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy
- Other inclusion criteria may apply
Exclusion
- Subjects withdrawn from N01175 (NCT00175903) trial for any reason
- Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
- Subject requiring add-on antiepileptic treatment
- Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
- Sexually active woman with childbearing potential who is not using a medically accepted birth control method
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00291655
Start Date
June 1 2006
End Date
April 1 2008
Last Update
May 18 2015
Active Locations (35)
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1
Bruges, Belgium
2
Edegem, Belgium
3
Ghent, Belgium
4
Haine-Saint-Paul, Belgium