Trial Outcomes & Findings for Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903). (NCT NCT00291655)

NCT ID: NCT00291655

Last Updated: 2015-05-18

Results Overview

Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 130 participants
• Primary outcome timeframe: during open-label therapy phase of 18 months
• Results posted on: 2015-05-18

Participant Flow

Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.

Participant milestones

Measure	Levetiracetam Open- Label Treatment Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Overall Study STARTED	130
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Levetiracetam Open- Label Treatment n=130 Participants Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Age, Continuous	40.68 years STANDARD_DEVIATION 18.35 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Region of Enrollment France	18 participants n=5 Participants
Region of Enrollment Finland	9 participants n=5 Participants
Region of Enrollment Poland	32 participants n=5 Participants
Region of Enrollment Belgium	25 participants n=5 Participants
Region of Enrollment Bulgaria	31 participants n=5 Participants
Region of Enrollment Switzerland	15 participants n=5 Participants

PRIMARY outcome

Timeframe: during open-label therapy phase of 18 months

Population: Safety population that includes all subjects that have been treated once.

Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).

Outcome measures

Measure	Levetiracetam Open- Label Treatment n=130 Participants Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with at least one AE	40 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with AEs leading to dose change	8 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with AEs leading to trial discontinuation	1 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with drug-related AEs	16 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with AEs of severe intensity	4 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with serious AEs	6 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Subjects with study drug-related serious AEs	0 participants
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase Number of deaths	0 participants

SECONDARY outcome

Timeframe: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

Population: Subjects with a discontinuation visit

Outcome measures

Measure	Levetiracetam Open- Label Treatment n=79 Participants Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months	0.71 kg Standard Deviation 3.16

Adverse Events

Levetiracetam Open- Label Treatment

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levetiracetam Open- Label Treatment n=130 participants at risk Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Cardiac disorders Acute coronary syndrome	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Hepatobiliary disorders Hepatic cirrhosis	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Injury, poisoning and procedural complications Skin laceration	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Nervous system disorders Grand mal convulsion	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Psychiatric disorders Alcoholism	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Infections and infestations Tonsillitis	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months
Injury, poisoning and procedural complications Foot fracture	0.77% 1/130 • Number of events 1 • Open-label treatment over 18 months

Other adverse events

Measure	Levetiracetam Open- Label Treatment n=130 participants at risk Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Investigations Weight decreased	2.3% 3/130 • Number of events 3 • Open-label treatment over 18 months
Investigations Weight increased	5.4% 7/130 • Number of events 7 • Open-label treatment over 18 months

Additional Information

UCB Clinical trial call center

UCB Pharma

Phone: +1 877 822 9493

Results disclosure agreements

• Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
• Publication restrictions are in place

Restriction type: OTHER