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Trial record 1 of 1 for:    15917462 [PUBMED-IDS]
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Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

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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
Show Outcome Measure DataHide 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
Name/Title: Dr. Jamie Zeitzer
Organization: VAPAHCS
Phone: 6504935000 ext 62410
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