Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
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).
2 other identifiers
interventional
130
6 countries
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2006
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 14, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
November 13, 2009
CompletedMay 18, 2015
April 1, 2015
1.8 years
February 10, 2006
August 25, 2009
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
during open-label therapy phase of 18 months
Secondary Outcomes (1)
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months
Study Arms (1)
Levetiracetam (LEV)
EXPERIMENTALInterventions
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (35)
Unknown Facility
Bruges, Belgium
Unknown Facility
Edegem, Belgium
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Ghent, Belgium
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Haine-Saint-Paul, Belgium
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Jette, Belgium
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Kortrijk, Belgium
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Leuven, Belgium
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Ostend, Belgium
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Sofia, Bulgaria
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Varna, Bulgaria
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Hus (helsinki), Finland
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Kuopio, Finland
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Tampere, Finland
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Blaye, France
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Bordeaux, France
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Brest, France
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Carcassonne, France
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Cherbourg, France
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Lille, France
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Lyon, France
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Nancy, France
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Rennes, France
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Saint-Brieuc, France
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Saint-Quentin, France
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Toulouse, France
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Valenciennes, France
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Częstochowa, Poland
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Krakow, Poland
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Olsztyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Biel, Switzerland
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Lausanne, Switzerland
Unknown Facility
Sankt Gallen, Switzerland
Unknown Facility
Zurich, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical trial call center
- Organization
- UCB Pharma
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 14, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
May 18, 2015
Results First Posted
November 13, 2009
Record last verified: 2015-04