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Trial record 64 of 240 for:    (armodafinil)

Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

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.
 
ClinicalTrials.gov Identifier: NCT00626210
Recruitment Status : Terminated
First Posted : February 29, 2008
Results First Posted : October 30, 2014
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Insomnia
Sleep Initiation and Maintenance Disorders
Alzheimer Disease
Intervention Drug: modafinil
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modafinil
Hide Arm/Group Description daily 100 mg of modafinil within 1 hr of awakening for one week followed by daily 200 mg of modafinil within 1 hr of awakening for one week
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Modafinil
Hide Arm/Group Description Open label study in which all participants get modafinil
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Nocturnal Sleep Length at 1 Month
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 2
Median (Full Range)
Unit of Measure: hours
9.5
(9.5 to 9.5)
2.Secondary Outcome
Title Improvement of Daytime Alertness and Quality of Life.
Hide Description [Not Specified]
Time Frame ~1 month
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modafinil
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Modafinil
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modafinil
Affected / at Risk (%)
Total   0/2 (0.00%) 
Early termination leading to small numbers of subjects analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jamie Zeitzer
Organization: VAPAHCS
Phone: 6504935000 ext 62410
EMail: jzeitzer@stanford.edu
Layout table for additonal information
Responsible Party: Jamie M. Zeitzer, Ph.D., VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT00626210     History of Changes
Other Study ID Numbers: 8564
First Submitted: February 20, 2008
First Posted: February 29, 2008
Results First Submitted: June 12, 2014
Results First Posted: October 30, 2014
Last Update Posted: January 29, 2018