Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01210690
• Date of registration: 23/09/2010
• Prospective Registration: Yes
• Primary sponsor: UCB Pharma
• Public title: Observational Study in Infants Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution
• Scientific title: Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice
• Date of first enrolment: January 2011
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01210690
• Study type: Observational
• Phase: N/A

Countries of recruitment

France, Germany, Greece, Italy, Poland, Spain, United Kingdom

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- diagnosis of epilepsy

- being treated with Keppra® Oral Solution

- aged between 1 month and 11 months inclusive at study baseline

Exclusion Criteria:



Age minimum: 1 Month
Age maximum: 11 Months
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Primary Outcome(s)

Treatment-Emergent Adverse Events (TEAEs) From Baseline Through Safety Follow-up Visit [Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)]

Secondary Outcome(s)

Mean Change From Baseline in Standardized Body Weight Scores at the Safety Follow-up Visit [Time Frame: From Baseline to the safety follow-up visit (maximum treatment period is 12 months plus 2-week safety follow-up)]

Presence of Deviation From the Normal Milestones of Psychomotor Development From Baseline to the Last Treatment Visit [Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)]

Mean Change From Baseline in Standardized Head Circumference Scores at the Safety Follow-up Visit [Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)]

Number of Patients With Abnormalities Noted During Physical Examination From Baseline to the Last Treatment Visit [Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)]

Incidence of Overall Serious Treatment-Emergent Adverse Events (TEAEs) From Baseline Through the Safety Follow-up [Time Frame: From Baseline through the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-weeks safety follow-up)]

Global Evaluation Scale of Epilepsy Severity (GES) [Time Frame: From Baseline to the last Treatment Visit (maximum time frame is 12 months)]

Global Evaluation Scale of the Psychomotor Development (GES) [Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)]

Incidence of Treatment-Emergent Adverse Events (TEAEs) Leading to Temporary or Permanent Discontinuation of Keppra® (Levetiracetam) From Baseline Through the Last Visit [Time Frame: From Baseline through the last Treatment Visit (maximum 12 months)]

Number of Patients Who Withdraw Due to Lack or Loss of Efficacy During the Treatment Period [Time Frame: From Baseline through the last Treatment Visit (maximum 12 months)]

Mean Change From Baseline in Standardized Body Length Scores at the Safety Follow-up Visit [Time Frame: From Baseline to the Safety Follow-up Visit (maximum Treatment Period is 12 months plus 2-week safety follow-up)]

Number of Patients With Abnormalities Noted During Neurological Examination From Baseline to the Last Treatment Visit [Time Frame: From Baseline to the last Treatment Visit (maximum 12 months)]

Secondary ID(s)

2009-017333-21

N01357

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/11/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01210690