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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291655
First Posted: February 14, 2006
Last Update Posted: May 18, 2015
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.
Information provided by (Responsible Party):
UCB Pharma
  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
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).

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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 ]
    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 ]

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: Levetiracetam (LEV) Drug: Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

  Eligibility

Information from the National Library of Medicine

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, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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 Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00291655     History of Changes
Other Study ID Numbers: N01237
EUDRACT NUMBER: 2006-000173-29
First Submitted: February 10, 2006
First Posted: February 14, 2006
Results First Submitted: August 25, 2009
Results First Posted: November 13, 2009
Last Update Posted: May 18, 2015
Last Verified: April 2015

Keywords provided by UCB Pharma:
NEWLY DIAGNOSED EPILEPSY
LEVETIRACETAM
KEPPRA
N01175 (NCT00175903)

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs