Trial Outcomes & Findings for Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening (NCT NCT00870688)

NCT ID: NCT00870688

Last Updated: 2009-05-20

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 82 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2009-05-20

Participant Flow

In total 82 patients were included in this trial. The patients were naive or changed from another antiepileptic or valproate preparation to valproate sustained release minitablets once daily in the evening.

Participant milestones

Measure	Sodium Valproate Epilepsy patients receive valproate sustained release minitablets, once daily.
Overall Study STARTED	82
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Sodium Valproate Epilepsy patients receive valproate sustained release minitablets, once daily.
Overall Study Lost to Follow-up	2
Overall Study Death, Unrelated	1
Overall Study Granules in the Stools	1

Baseline Characteristics

Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

Baseline characteristics by cohort

Measure	Sodium Valproate n=82 Participants Epilepsy patients receive valproate sustained release minitablets, once daily.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=93 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants
Age Continuous	45.9 years STANDARD_DEVIATION 23 • n=93 Participants
Sex: Female, Male Female	43 Participants n=93 Participants
Sex: Female, Male Male	39 Participants n=93 Participants

PRIMARY outcome

Timeframe: 7 weeks

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 weeks

Outcome measures

Measure	Sodium Valproate n=82 Participants Epilepsy patients receive valproate sustained release minitablets, once daily.
Number of Seizures Within 7 Weeks	1.6 seizures Standard Deviation 2.9

SECONDARY outcome

Timeframe: 7 weeks

Outcome measures

Outcome data not reported

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lohmueller

Desitin

Phone: 0049(0)40-59101

Email: lohmueller@desitin.de

Results disclosure agreements

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