Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00291655
First received: February 10, 2006
Last updated: August 30, 2011
Last verified: December 2009
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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 (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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Drug: Levetiracetam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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). |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
Drug Information available for:
Levetiracetam
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase [ Time Frame: during open-label therapy phase of 18 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Experimental: 1 |
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 |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291655
Locations
| Belgium | |
| Brugge, Belgium | |
| Edegem, Belgium | |
| Gent, Belgium | |
| Haine St Paul, Belgium | |
| Jette, Belgium | |
| Kortrijk, Belgium | |
| Leuven, Belgium | |
| Oostende, Belgium | |
| Bulgaria | |
| Sofia, Bulgaria | |
| Varna, Bulgaria | |
| Finland | |
| Hus (helsinki), Finland | |
| Kuopio, Finland | |
| Tampere, Finland | |
| France | |
| Blaye, France | |
| Bordeaux, France | |
| Brest, France | |
| Carcassonne, France | |
| Cherbourg, France | |
| Lille, France | |
| Lyon Cedex, France | |
| Nancy, France | |
| Rennes, France | |
| Saint Brieuc, France | |
| Saint Quentin, France | |
| TOULOUSE Cedex 04, France | |
| Valenciennes, France | |
| Poland | |
| Czestochowa, Poland | |
| Krakow, Poland | |
| Olstyn, Poland | |
| Poznan, Poland | |
| Warszawa, Poland | |
| Switzerland | |
| Biel, Switzerland | |
| Lausanne, Switzerland | |
| St Gallen, Switzerland | |
| Zurich, Switzerland | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00291655 History of Changes |
| Other Study ID Numbers: | N01237, EUDRACT NUMBER: 2006-000173-29 |
| Study First Received: | February 10, 2006 |
| Results First Received: | August 25, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Switzerland: Swissmedic |
Keywords provided by UCB, Inc.:
|
NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903) |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Etiracetam Piracetam Anticonvulsants |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013