Trial Outcomes & Findings for Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT01069523)

Results Overview

54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

Baseline and Follow up

Results posted on

2012-09-03

Participant Flow

Subjects were recruited from 4/2010 through 6/2011 primarily through flyers in child psychiatry clinics and by informing families who called the clinic intake line.

After diagnostic assessment and confirmation that subjects meet study criteria, subjects were scheduled for a baseline EEG and they performed the Stop Signal Task while ERP data was obtained. 42 subjects completed baseline evaluation,13 did not complete baseline EEG, leaving 29 to be randomized to drug

Participant milestones

Participant milestones
Measure	Placebo Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine Extended Release Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Overall Study STARTED	13	16
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine Extended Release Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Overall Study Withdrawal by Subject	4	7

Baseline Characteristics

Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=29 Participants Total of all reporting groups	Placebo n=13 Participants Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine Extended Release n=16 Participants Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Age, Categorical <=18 years	29 Participants n=5 Participants	13 Participants n=5 Participants	16 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants
Age Continuous	8.29 years STANDARD_DEVIATION 1.5 • n=5 Participants	8.78 years STANDARD_DEVIATION 1.8 • n=5 Participants	7.8 years STANDARD_DEVIATION 1.2 • n=7 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	7 Participants n=5 Participants	6 Participants n=7 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	6 Participants n=5 Participants	10 Participants n=7 Participants
Region of Enrollment United States	29 participants n=5 Participants	13 participants n=5 Participants	16 participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline and Follow up

54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine n=9 Participants Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Dupaul ADHD Rating Scale	31.4 units on a scale Standard Deviation 16.5	13.6 units on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Week 4 of study

Blinded clinician overall assessment of the child global improvement in behavior-1 is very much improved, 2-much improved, 3- minimally improved, 4 no change, 5-minimally worse, 6- much worse, 7- very much worse

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine n=9 Participants Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Clinical Global Impression- Improvement	3.0 units on a scale Standard Deviation 1.1	2.0 units on a scale Standard Deviation 0.5

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Guanfacine Extended Release

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=13 participants at risk Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).	Guanfacine Extended Release n=16 participants at risk Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Gastrointestinal disorders Stomachache	7.7% 1/13 • Number of events 1 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients	6.2% 1/16 • Number of events 1 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients
General disorders Dizziness	7.7% 1/13 • Number of events 1 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients	6.2% 1/16 • Number of events 1 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients
General disorders Sedation	23.1% 3/13 • Number of events 3 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients	31.2% 5/16 • Number of events 5 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients
General disorders Fatigue	0.00% 0/13 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients	18.8% 3/16 • Number of events 3 • Adverse events assessed at each visit covering the week prior Adverse events were spontaneously reported by patients

Additional Information

Steven R.Pliszka MD

University of Texas Health Science Center at San Antonio

Phone: 210-567-5475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place