NCT00150787
Completed
Phase 3
A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.
ConditionsEpilepsy, Tonic-clonic
DrugsLEVETIRACETAM
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- UCB Pharma
- Enrollment
- 250
- Primary Endpoint
- Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
Overview
Brief Summary
A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects with a confirmed diagnosis of epilepsy.
- •Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- •Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.
Exclusion Criteria
- •Need for an additional AED.
Outcomes
Primary Outcomes
Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
Secondary Outcomes
No secondary outcomes reported
Investigators
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