Overview

Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study

Status:
Completed

Trial end date:
2017-10-30

Target enrollment:
0

Participant gender:
All

Summary

This study was conducted to assess the efficacy and safety of DYANAVEL XR (amphetamine extended-release oral suspension, CII) for the treatment of symptoms of attention-deficit/hyperactivity disorder (ADHD) in children aged 6-12 years.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Tris Pharma, Inc.

Treatments:

Amphetamine

Criteria

Inclusion Criteria:

1. Males or females aged 6 to 12 years at the time of screening, inclusive

2. Diagnosed with ADHD by a psychiatrist within 6 months of study enrolment or newly
diagnosed with ADHD using the DSM-5 criteria for ADHD

3. An ADHD-RS-5 score at Screening ≥90th percentile for sex and age in at least one of
the following categories:

1. Hyperactive-impulsive subscale,

2. Inattentive subscale, or

3. Total score. Subjects who do not meet this criteria at screening can have
ADHD-RS-5 repeated at baseline, after washout of stimulant medication for a
minimum of 24 hours prior to baseline.

4. In the clinical judgment of the Investigator, the subject must be in need of
pharmacological treatment for ADHD.

5. Females of childbearing potential must be non-lactating and must have a negative serum
pregnancy test at screening

6. Provide written informed consent (parent/guardian) and assent (child aged 10 - 12
years only) prior to participation in the study

Exclusion Criteria:

1. Diagnosed with any DSM-5 active disorder (other than ADHD) with the exception of
specific phobias, learning disorders, motor skills disorders, communication disorders,
oppositional defiant disorder, elimination disorders, and sleep disorders

2. Known history of chronic medical illnesses including severe hypertension, untreated
thyroid disease, peripheral vasculopathy, known structural cardiac disorders, serious
cardiac conditions, serious arrhythmias, cardiomyopathy, known family history of
sudden death

3. Known history or presence of significant renal or hepatic disease, as indicated by
clinical laboratory assessment (liver function test results ≥ two times the upper
limit of normal, blood urea nitrogen, or creatinine).

4. Clinically significant abnormal ECG or cardiac findings on physical examination
(including the presence of a pathologic murmur)

5. Use of the following medications within 30 days of Baseline Visit:

- MAOI - monoamine oxidase inhibitors (e.g., Selegiline, isocarboxazid, phenelzine,
tranylcypromine)

- Tricyclic Antidepressants (e.g. Desipramine, protriptyline)

6. Use of the following medications within 3 days of Baseline Visit

- Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid
HCl, ascorbic acid)

- Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate,
methenamine salts)

7. Use of atomoxetine within 14 days of Baseline Visit

8. Planned use of prohibited drugs or agents from the Screening visit through the end of
the study

9. Abnormal clinically significantly laboratory test value at screening that, in the
opinion of the Investigator, would preclude study participation

10. Known history of allergy/hypersensitivity to amphetamine or any of the components of
Dyanavel XR, or topical anaesthetics

11. Known history of lack of response to amphetamine

12. Parent or guardian's inability or unwillingness to follow directions of the
Investigator or study research staff.

13. Any uncontrolled medical condition that in the opinion of the Investigator would
preclude study participation

14. History of significant illness requiring hospitalization, or surgery requiring
anaesthetics within 30 days of Baseline Visit