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

Epilepsy Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291655
• Other study ID #: N01237
• Secondary ID: EUDRACT NUMBER:
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2006
• Last updated: April 29, 2015
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2015
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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• Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Finland,  France,  Poland,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase	Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).	during open-label therapy phase of 18 months	Yes
Secondary	Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months		Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months	Yes

External Links

•   FDA Safety Alerts and Recalls
•   Product Information