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PET Study Examining the Dopaminergic Activity of Armodafinil in Adults

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ClinicalTrials.gov Identifier: NCT00592943
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : June 10, 2011
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Healthy
Intervention: Drug: armodafinil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twelve healthy human subjects between 18 and 55 years old were sequentially recruited from advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
12 healthy human subjects were enrolled and completed the study. Enrollment was gender-balanced. Six subjects (3 males, 3 females) were be randomly assigned to the C-11 altropane group; six subjects (3 males, 3 females) were be randomly assigned to the C-11 raclopride group, all in an open-label protocol.

Reporting Groups
  Description
Armodafinil (100mg) One 100 mg orally administered dose of Armodafini before PET scan.
Armodafinil (250mg) One 250 mg orally administered dose of Armodafini before PET scan.

Participant Flow:   Overall Study
    Armodafinil (100mg)   Armodafinil (250mg)
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  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
Armodafinil (100mg) One 100 mg orally administered dose of Armodafini before PET scan.
Armodafinil (250mg) One 250 mg orally administered dose of Armodafini before PET scan.
Total Total of all reporting groups

Baseline Measures
   Armodafinil (100mg)   Armodafinil (250mg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   12 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   6   12 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Full Range)
 25.13 
 (22.83 to 34.5) 
 21.44 
 (18.75 to 22.92) 
 23.29 
 (18.75 to 34.5) 
Gender 
[Units: Participants]
     
Female   3   3   6 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   6   6   12 


  Outcome Measures

1.  Primary:   Armodafinil DAT Occupancy in Caudate   [ Time Frame: DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil ]

2.  Primary:   Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)   [ Time Frame: Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits ]

3.  Primary:   Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)   [ Time Frame: Extracellular DAT was measured using the PET scan at 2.5 hours after oral administration of 100mg or 250 mg Armodafinil on three different study visits ]


  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
Extracellular dopamine could compete with [11C] altropane, causing an overestimation of DAT occupancy. Time between scans and menstrual cycle could be sources of variability. Brain pathology although unlikely in normal subjects, is possible.


  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: Thomas J. Spencer, MD
Organization: Massachusetts General Hospital; Harvard Medical School
phone: (617) 726-1731
e-mail: tspencer@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00592943     History of Changes
Other Study ID Numbers: 2007-P-001659
First Submitted: December 28, 2007
First Posted: January 14, 2008
Results First Submitted: February 15, 2011
Results First Posted: June 10, 2011
Last Update Posted: November 13, 2013