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

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ClinicalTrials.gov Identifier: NCT01318408
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : June 23, 2015
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )

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
  Description
Open Label All participants received study drug.

Participant Flow:   Overall Study
    Open Label
STARTED   24 
COMPLETED   16 
NOT COMPLETED   8 



  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
  Description
Open Label All participants received study drug.

Baseline Measures
   Open Label 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Full Range)
 69.9 
 (50 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  45.8% 
Male      13  54.2% 
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 ]


  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
e-mail: clippa@drexelmed.edu


Publications:

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov 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: September 13, 2018