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| Sponsored by: |
UCB |
|---|---|
| Information provided by: | UCB |
| ClinicalTrials.gov Identifier: | NCT00291655 |
Purpose
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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Levetiracetam |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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. |
| Enrollment: | 130 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Levetiracetam
500mg oral tablets,1000 - 3000 mg/day, bid, duration of the study
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other inclusion criteria may apply
Exclusion Criteria:
Contacts and Locations| Belgium | |
| BRUGGE, Belgium | |
| HAINE ST PAUL, Belgium | |
| OOSTENDE, Belgium | |
| EDEGEM, Belgium | |
| KORTRIJK, Belgium | |
| GENT, Belgium | |
| LEUVEN, Belgium | |
| Jette, Belgium | |
| Bulgaria | |
| VARNA, Bulgaria | |
| SOFIA, Bulgaria | |
| Finland | |
| HUS (HELSINKI), Finland | |
| TAMPERE, Finland | |
| Kuopio, Finland | |
| France | |
| RENNES, France | |
| VALENCIENNES, France | |
| BORDEAUX, France | |
| SAINT BRIEUC, France | |
| BREST, France | |
| SAINT QUENTIN, France | |
| CHERBOURG, France | |
| LYON CEDEX, France | |
| LILLE, France | |
| TOULOUSE Cedex 04, France | |
| CARCASSONNE, France | |
| Nancy, France | |
| Blaye, France | |
| Poland | |
| OLSTYN, Poland | |
| WARSZAWA, Poland | |
| CZESTOCHOWA, Poland | |
| Krakow, Poland | |
| Poznan, Poland | |
| Warszawa, Poland | |
| Switzerland | |
| BIEL, Switzerland | |
| Zurich, Switzerland | |
| LAUSANNE, Switzerland | |
| ZURICH, Switzerland | |
| ST GALLEN, Switzerland | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
| Responsible Party: | UCB ( Study Director ) |
| Study ID Numbers: | N01237, EUDRACT NUMBER: 2006-000173-29 |
| Study First Received: | February 10, 2006 |
| Last Updated: | May 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00291655 History of Changes |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Bulgaria: Bulgarian Drug Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Switzerland: Swissmedic |
|
NEWLY DIAGNOSED EPILEPSY, LEVETIRACETAM, KEPPRA, F-UP N01175 |
|
Nootropic Agents Epilepsy Piracetam Central Nervous System Diseases |
Etiracetam Brain Diseases Neuroprotective Agents Anticonvulsants |
|
Nootropic Agents Physiological Effects of Drugs Nervous System Diseases Central Nervous System Diseases Brain Diseases Neuroprotective Agents Protective Agents |
Pharmacologic Actions Epilepsy Therapeutic Uses Piracetam Etiracetam Central Nervous System Agents Anticonvulsants |
