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

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).”

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.

Intervention(s) in this Clinical Trial

• Drug: Levetiracetam
  • 500mg oral tablets,1000 - 3000 mg/day, bid, duration of the study

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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• Subjects withdrawn from N01175 (NCT00175903) trial for any reason.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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: UCB, Inc. Industry

Overall Clinical Trial Officials and Contacts

UCB Clinical Trial Call Center Study Director +1 877 822 9493 (UCB)  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00291655

Study ID Number: N01237

ClinicalTrials.gov Identifier: NCT00291655

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

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