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Tolerability and Efficacy of Depakote-extended Release in the Elderly

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ClinicalTrials.gov Identifier: NCT00318929
Recruitment Status : Completed
First Posted : April 27, 2006
Results First Posted : July 9, 2010
Last Update Posted : February 2, 2018
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Elderly
Intervention: Drug: Divalproex Sodium Extended-Release Tablets

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began April 2006 and completed January 2008. Subjects were seen in an outpatient clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects recruited had either inadequately controlled seizures or were taking Depakote twice a day.

Reporting Groups
Depakote ER Dosing regimen from 750 to 1250 mg once a day.

Participant Flow:   Overall Study
    Depakote ER

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Depakote ER Dosing regimen from 750 to 1250 mg once a day.

Baseline Measures
   Depakote ER 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      12  85.7% 
>=65 years      2  14.3% 
[Units: Years]
Mean (Standard Deviation)
 66.1  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      3  21.4% 
Male      11  78.6% 
Region of Enrollment 
[Units: Participants]
United States   14 

  Outcome Measures

1.  Primary:   Effectiveness of Medication as Measured by Participation Through the End of the Trial.   [ Time Frame: 24 weeks ]

2.  Secondary:   Patient's Compliance With Once a Day Dosing.   [ Time Frame: 24 weeks ]

3.  Secondary:   Number of Seizures Per Month   [ Time Frame: 24 weeks ]

4.  Secondary:   Change From Baseline as Measured by the Seizure Severity Questionnaire (SSQ)   [ Time Frame: 24 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Alan R. Towne, MD
Organization: Virginia Commonwealth University
phone: 804-282-9869
e-mail: atowne@mcvh-vcu.edu

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00318929     History of Changes
Other Study ID Numbers: VCUHM10204
First Submitted: April 25, 2006
First Posted: April 27, 2006
Results First Submitted: March 31, 2009
Results First Posted: July 9, 2010
Last Update Posted: February 2, 2018