Trial Outcomes & Findings for PET Study Examining the Dopaminergic Activity of Armodafinil in Adults (NCT NCT00592943)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil

Results posted on

2013-11-13

Participant Flow

Twelve healthy human subjects between 18 and 55 years old were sequentially recruited from advertisements.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PET Study Examining the Dopaminergic Activity of Armodafinil in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil (100mg) n=6 Participants One 100 mg orally administered dose of Armodafini before PET scan.	Armodafinil (250mg) n=6 Participants One 250 mg orally administered dose of Armodafini before PET scan.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.13 Years FULL_RANGE 1.1 • n=5 Participants	21.44 Years FULL_RANGE 2.5 • n=7 Participants	23.29 Years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: DAT occupancy was measured using the PET scan at 1 hour and 2.5 hours after oral administration of 100mg or 250 mg Armodafinil

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).

Outcome measures

Outcome measures
Measure	Armodafinil (100mg) n=6 Participants One 100 mg orally administered dose of Armodafini before PET scan.	Armodafinil (250mg) n=6 Participants One 250 mg orally administered dose of Armodafini before PET scan.
Armodafinil DAT Occupancy in Caudate 1 Hour	34.0 μg/mL Standard Deviation 9.0	60.5 μg/mL Standard Deviation 7.4
Armodafinil DAT Occupancy in Caudate 2.5 hours	40.4 μg/mL Standard Deviation 9.5	65.2 μg/mL Standard Deviation 6.1

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Armodafinil (100mg) n=6 Participants One 100 mg orally administered dose of Armodafini before PET scan.	Armodafinil (250mg) n=6 Participants One 250 mg orally administered dose of Armodafini before PET scan.
Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier)	17.8 μg/mL Standard Deviation 30.1	7.0 μg/mL Standard Deviation 8.6

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Armodafinil (100mg) n=5 Participants One 100 mg orally administered dose of Armodafini before PET scan.	Armodafinil (250mg) n=5 Participants One 250 mg orally administered dose of Armodafini before PET scan.
Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier)	6.0 μg/mL Standard Deviation 9.4	5.3 μg/mL Standard Deviation 8.5

Adverse Events

Armodafinil (100mg)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Armodafinil (250mg)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Armodafinil (100mg) n=6 participants at risk One 100 mg orally administered dose of Armodafini before PET scan.	Armodafinil (250mg) n=6 participants at risk One 250 mg orally administered dose of Armodafini before PET scan.
Nervous system disorders slightly jittery	16.7% 1/6 • Number of events 1	0.00% 0/6
Nervous system disorders headache	16.7% 1/6 • Number of events 2	16.7% 1/6 • Number of events 2
Respiratory, thoracic and mediastinal disorders cold/ congestion	16.7% 1/6 • Number of events 1	0.00% 0/6
Musculoskeletal and connective tissue disorders muscle soreness	0.00% 0/6	16.7% 1/6 • Number of events 1
Nervous system disorders dizziness	0.00% 0/6	16.7% 1/6 • Number of events 1
Nervous system disorders hyperactivity	0.00% 0/6	16.7% 1/6 • Number of events 1
Musculoskeletal and connective tissue disorders shoulder pain	0.00% 0/6	16.7% 1/6 • Number of events 1

Additional Information

Thomas J. Spencer, MD

Massachusetts General Hospital; Harvard Medical School

Phone: (617) 726-1731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place