Clinical trial NCT00291655: Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
Official title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: NEWLY DIAGNOSED EPILEPSY
LEVETIRACETAM
KEPPRA
N01175 (NCT00175903)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 130
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

Primary outcomes:
measure: Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
timeFrame: during open-label therapy phase of 18 months
Secondary outcomes:
measure: Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
timeFrame: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Haine St Paul
country: Belgium
city: Jette
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Oostende
country: Belgium
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Hus (helsinki)
country: Finland
city: Kuopio
country: Finland
city: Tampere
country: Finland
city: Blaye
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Carcassonne
country: France
city: Cherbourg
country: France
city: Lille
country: France
city: Lyon Cedex
country: France
city: Nancy
country: France
city: Rennes
country: France
city: Saint Brieuc
country: France
city: Saint Quentin
country: France
city: TOULOUSE Cedex 04
country: France
city: Valenciennes
country: France
city: Czestochowa
country: Poland
city: Krakow
country: Poland
city: Olstyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Biel
country: Switzerland
city: Lausanne
country: Switzerland
city: St Gallen
country: Switzerland
city: Zurich
country: Switzerland
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: