Trial Outcomes & Findings for Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures (NCT NCT03940326)

NCT ID: NCT03940326

Last Updated: 2022-02-17

Results Overview

The time interval from the beginning of the study to occurrence of the first seizure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-02-17

Participant Flow

Participant milestones

Measure	Levetiracetam Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Overall Study STARTED	45	58
Overall Study COMPLETED	45	58
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures

Baseline characteristics by cohort

Measure	Levetiracetam n=45 Participants Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 Participants Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.	Total n=103 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	58 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	26.2 years STANDARD_DEVIATION 8.1 • n=5 Participants	29 years STANDARD_DEVIATION 9.7 • n=7 Participants	27.7 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	41 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	58 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Iran	45 Participants n=5 Participants	58 Participants n=7 Participants	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The time interval from the beginning of the study to occurrence of the first seizure

Outcome measures

Measure	Levetiracetam n=45 Participants Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 Participants Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Time to First Seizure	169 Days Standard Deviation 6.1	178 Days Standard Deviation 2.2

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Levetiracetam n=45 Participants Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 Participants Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Seizure Freedom Rate	40 Participants	50 Participants

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Measure	Levetiracetam n=45 Participants Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 Participants Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Withdrawal Rate	4 Participants	6 Participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Measure	Levetiracetam n=45 Participants Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 Participants Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Time to Withdrawal	220 Days Standard Deviation 8.7	172 Days Standard Deviation 4.1

Adverse Events

Levetiracetam

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Valproate

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	Levetiracetam n=45 participants at risk Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 participants at risk Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Hepatobiliary disorders Rise in liver enzymes	0.00% 0/45 • 6 months	3.4% 2/58 • Number of events 2 • 6 months

Other adverse events

Measure	Levetiracetam n=45 participants at risk Levetiracetam: Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred	Valproate n=58 participants at risk Valproate: Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
Endocrine disorders Weight gain	0.00% 0/45 • 6 months	27.6% 16/58 • Number of events 16 • 6 months
Skin and subcutaneous tissue disorders Hair loss	0.00% 0/45 • 6 months	1.7% 1/58 • Number of events 1 • 6 months
Endocrine disorders Irregularity of menstrual period	0.00% 0/45 • 6 months	1.7% 1/58 • Number of events 1 • 6 months
Nervous system disorders Somnolence	6.7% 3/45 • Number of events 3 • 6 months	5.2% 3/58 • Number of events 3 • 6 months
General disorders Tiredness	2.2% 1/45 • Number of events 1 • 6 months	3.4% 2/58 • Number of events 2 • 6 months
Nervous system disorders Tremor	0.00% 0/45 • 6 months	1.7% 1/58 • Number of events 1 • 6 months
Gastrointestinal disorders Dyspepsia	0.00% 0/45 • 6 months	10.3% 6/58 • Number of events 6 • 6 months
Nervous system disorders Dizziness/vertigo	13.3% 6/45 • Number of events 6 • 6 months	1.7% 1/58 • Number of events 1 • 6 months
Nervous system disorders Psychiatric symptoms	20.0% 9/45 • Number of events 9 • 6 months	0.00% 0/58 • 6 months
General disorders Abnormal laboratory findings	0.00% 0/45 • 6 months	3.4% 2/58 • Number of events 2 • 6 months

Additional Information

Nasim Tabrizi

Mazandaran University of medical sciences

Phone: +981133343015

Email: nasimtabrizi@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place