Trial Outcomes & Findings for Tolerability and Efficacy of Depakote-extended Release in the Elderly (NCT NCT00318929)

Results Overview

Number of participants completing the trial

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

24 weeks

Results posted on

2018-02-05

Participant Flow

Recruitment began April 2006 and completed January 2008. Subjects were seen in an outpatient clinic

Subjects recruited had either inadequately controlled seizures or were taking Depakote twice a day.

Participant milestones

Participant milestones
Measure	Depakote ER Dosing regimen from 750 to 1250 mg once a day.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tolerability and Efficacy of Depakote-extended Release in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Depakote ER n=14 Participants Dosing regimen from 750 to 1250 mg once a day.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	66.1 years STANDARD_DEVIATION 9.5 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	11 Participants n=99 Participants
Region of Enrollment United States	14 participants n=99 Participants

PRIMARY outcome

Timeframe: 24 weeks

Number of participants completing the trial

Outcome measures

Outcome measures
Measure	Depakote ER n=14 Participants Dosing regimen from 750 to 1250 mg once a day.
Effectiveness of Medication as Measured by Participation Through the End of the Trial.	14 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.

Subjects pill count for once a day dosing and compliance with medication as a percent of total doses prescribed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.

Count of seizures per month determined by seizures recorded in diaries.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results.

Seizure Severity Questionnaire summary score, on a scale of 1 to 7 with one being the least severe and 7 being the most severe, components of seizures include; warning, activity and recovery

Outcome measures

Outcome data not reported

Adverse Events

Depakote ER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alan R. Towne, MD

Virginia Commonwealth University

Phone: 804-282-9869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60