Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00291655 |
|
Recruitment Status :
Completed
First Posted : February 14, 2006
Results First Posted : November 13, 2009
Last Update Posted : May 18, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Levetiracetam | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 130 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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). |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Levetiracetam (LEV) |
Drug: Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study |
- 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 ]Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291655
| 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 | |
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00291655 |
| Other Study ID Numbers: |
N01237 EUDRACT NUMBER: 2006-000173-29 |
| First Posted: | February 14, 2006 Key Record Dates |
| Results First Posted: | November 13, 2009 |
| Last Update Posted: | May 18, 2015 |
| Last Verified: | April 2015 |
|
NEWLY DIAGNOSED EPILEPSY LEVETIRACETAM KEPPRA N01175 (NCT00175903) |
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Levetiracetam Anticonvulsants Nootropic Agents |