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Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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trial and benefited from levetiracetam monotherapy Other inclusion criteria may apply Exclusion Criteria: Subjects withdrawn from N01175 (NCT00175903) trial for any reason Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial Subject requiring add-on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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levetiracetam (LEV)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months

Full Information

First Posted
February 10, 2006
Last Updated
April 29, 2015
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00291655
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, N01175 (NCT00175903)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levetiracetam (LEV)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Primary Outcome Measure Information:
Title
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
Description
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
Time Frame
during open-label therapy phase of 18 months
Secondary Outcome Measure Information:
Title
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months
Time Frame
Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
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

12. IPD Sharing Statement

Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

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