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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:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00291655
First received: February 10, 2006
Last updated: August 30, 2011
Last verified: December 2009
  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:


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 ] [ 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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: UCB Pharma
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 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
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014