Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

Generalized Epilepsy Clinical Trial

Official title:

An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150748
• Other study ID #: N167
• Secondary ID: 2004-001997-13
• Status: Completed
• Phase: Phase 3
• Start date: November 2001
• Est. completion date: July 2007

Study information

• Verified date: July 2020
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 64 Years

Eligibility

Inclusion Criteria:

• Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)

• Subjects who were/are suffering from primary generalized (type II) epileptic seizures

• Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected

Exclusion Criteria:

• Known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol

• Concomitant use of any drug with possible central nervous system effects unless at a stable dose

• Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Generalized Epilepsy

Intervention

Drug:
• Levetiracetam 166 mg
Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 166 mg Route of Administration: Oral use
• Levetiracetam 250 mg
Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 250 mg Route of Administration: Oral use
• Levetiracetam 500 mg
Active Substance: Levetiracetam Pharmaceutical Form: Tablet Concentration: 500 mg Route of Administration: Oral use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period		Evaluation Period
Primary	Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period		Evaluation Period
Secondary	Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period		From Visit 1 to the end of the Evaluation Period
Secondary	Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period		From Visit 1 to the end of the Evaluation Period
Secondary	Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types		From N01057 or N166 Baseline to the Evaluation Period
Secondary	Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types		From N01057 or N166 Baseline to the Evaluation Period
Secondary	Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations		From N01057 or N166 Baseline to the Evaluation Period
Secondary	Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations		From N01057 or N166 Baseline to the Evaluation Period
Secondary	Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations		Evaluation Period
Secondary	Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types		Evaluation Period

External Links

•   Clinical Study Summary on UCB.com