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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
Enrollment 12
Recruitment Details Twelve healthy human subjects between 18 and 55 years old were sequentially recruited from advertisements.
Pre-assignment Details 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.
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg)
Hide Arm/Group Description One 100 mg orally administered dose of Armodafini before PET scan. One 250 mg orally administered dose of Armodafini before PET scan.
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg) Total
Hide Arm/Group Description One 100 mg orally administered dose of Armodafini before PET scan. One 250 mg orally administered dose of Armodafini before PET scan. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
25.13
(22.83 to 34.5)
21.44
(18.75 to 22.92)
23.29
(18.75 to 34.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
3
  50.0%
3
  50.0%
6
  50.0%
Male
3
  50.0%
3
  50.0%
6
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Armodafinil DAT Occupancy in Caudate
Hide Description Subjects received each dose level (100 and 250 mg) of armodafinil, followed by PET scans, in an open-label protocol. Repeat PET scans, using [1 1 C]altropane, determined DAT occupancy at 1 hour and 2.5 hours postdose (compared with baseline).
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg)
Hide Arm/Group Description:
One 100 mg orally administered dose of Armodafini before PET scan.
One 250 mg orally administered dose of Armodafini before PET scan.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: μg/mL
1 Hour 34.0  (9.0) 60.5  (7.4)
2.5 hours 40.4  (9.5) 65.2  (6.1)
2.Primary Outcome
Title Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)
Hide Description Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg)
Hide Arm/Group Description:
One 100 mg orally administered dose of Armodafini before PET scan.
One 250 mg orally administered dose of Armodafini before PET scan.
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: μg/mL
17.8  (30.1) 7.0  (8.6)
3.Primary Outcome
Title Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)
Hide Description Each subject received each dose level (one dose per day of 100 or 250 mg) of armodafinil, followed by PET scans using [11C]raclopride, to determine the change in extracellular dopamine at 2.5 hours postdose.
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg)
Hide Arm/Group Description:
One 100 mg orally administered dose of Armodafini before PET scan.
One 250 mg orally administered dose of Armodafini before PET scan.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: μg/mL
6.0  (9.4) 5.3  (8.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Armodafinil (100mg) Armodafinil (250mg)
Hide Arm/Group Description One 100 mg orally administered dose of Armodafini before PET scan. One 250 mg orally administered dose of Armodafini before PET scan.
All-Cause Mortality
Armodafinil (100mg) Armodafinil (250mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Armodafinil (100mg) Armodafinil (250mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Armodafinil (100mg) Armodafinil (250mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      5/6 (83.33%)    
Musculoskeletal and connective tissue disorders     
muscle soreness  0/6 (0.00%)  0 1/6 (16.67%)  1
shoulder pain  0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders     
slightly jittery  1/6 (16.67%)  1 0/6 (0.00%)  0
headache  1/6 (16.67%)  2 1/6 (16.67%)  2
dizziness  0/6 (0.00%)  0 1/6 (16.67%)  1
hyperactivity  0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders     
cold/ congestion  1/6 (16.67%)  1 0/6 (0.00%)  0
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.
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
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