Trial record 1 of 1 for:    10675135 [PUBMED-IDS]
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Levetiracetam: The Anti-Convulsant of Choice for Elderly Patients With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01318408
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : June 23, 2015
Last Update Posted : June 23, 2015
UCB Pharma
Information provided by (Responsible Party):
Carol Lippa, Drexel University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Epilepsy
Intervention: Drug: Levetiracetam

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Open Label All participants received study drug.

Participant Flow:   Overall Study
    Open Label

  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
Open Label All participants received study drug.

Baseline Measures
   Open Label 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (50 to 84) 
[Units: Participants]
Female   11 
Male   13 
Region of Enrollment 
[Units: Participants]
United States   24 

  Outcome Measures

1.  Primary:   MMSE at Baseline and at Three (3) Months.   [ Time Frame: Baseline and Three months ]

2.  Primary:   ADAS-cog at Baseline and at 3 Months.   [ Time Frame: Baseline and Three (3) months ]

3.  Secondary:   Several Ratings Such as Activities of Daily Living, Behavior and Motor Activity Will Also be Evaluated.   [ Time Frame: three months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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 NOT 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.

Results Point of Contact:  
Name/Title: Carol Lippa, MD
Organization: Drexel University College of Medicine
phone: 215-762-7090


Responsible Party: Carol Lippa, Drexel University Identifier: NCT01318408     History of Changes
Other Study ID Numbers: KEPPRA
WIRB # 20061543 ( Other Identifier: UCB pharma grant to DUCOM )
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: February 17, 2014
Results First Posted: June 23, 2015
Last Update Posted: June 23, 2015