Trial Outcomes & Findings for Dyanavel® XR Extended-Release Oral Suspension in the Treatment of Children With ADHD: A Laboratory School Study (NCT NCT03088267)

Last Updated: 2019-07-22

Results Overview

Change in SKAMP-C (Swanson, Kotkin, Agler, M-Flynn, and Pelham combined) score from pre-dose, by treatment. The SKAMP-C is a rating scale that assesses functional impairment related to ADHD in the classroom, including the performance of academic tasks, following class rules, and interacting with peers and adults in the classroom. The SKAMP-C is a 13-item, 7-score rating system (0=normal to 7=maximal impairment). The higher the score, the worse the impairment. A decrease from baseline in the combined (all 13 items) score indicates improvement. The SKAMP-C is used to assess the time course of treatment effects in laboratory classroom studies.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Change in SKAMP-C score from baseline to 30 minutes postdose.

Results posted on

2019-07-22

Participant Flow

Date first subject enrolled: February 11, 2017 Date last subject completed: February 25, 2017

All 18 subjects were enrolled and completed the study.

Participant milestones

Participant milestones
Measure	Sequence: AMPH EROS/Placebo Patients optimized on open label dose of AMPH EROS. Randomized to optimized dose of AMPH EROS for 1 day. Laboratory classroom assessment takes place. Then crossover to placebo for 4-5 days followed by second laboratory classroom assessment.	Sequence: Placebo/AMPH EROS Patients optimized on open label dose of AMPH EROS. Randomized to placebo for 1 day. Laboratory classroom assessment takes place. Then crossover to optimized dose of AMPH EROS for 4-5 days followed by second laboratory classroom assessment.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=18 Participants Open label phase: amphetamine extended-release oral suspension, 2.5 mg/mL at optimal dose Double blind phase: A single dose of amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM, or placebo extended-release oral suspension: 6, 7 or 8 mL PO
Age, Customized	10 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in SKAMP-C score from baseline to 30 minutes postdose.

Population: Intent to Treat Population: 18 subjects

Outcome measures

Outcome measures
Measure	Active Treatment n=18 Participants Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO Placebo extended-release oral suspension: 6, 7 or 8 mL PO	Placebo Treatment n=18 Participants Double blind placebo, 6, 7 or 8 mL po QAM amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO Placebo extended-release oral suspension: 6, 7 or 8 mL PO
Change in Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Combined Scores, Baseline to 30 Minutes Post Dose	-6.1 number of questions answered correctly Standard Error 2.29	2.5 number of questions answered correctly Standard Error 2.29

SECONDARY outcome

Timeframe: 30 minutes postdose and 3 hours postdose

Population: Intention to treat

Change from pre-dose in PERMP-C scores (Permanent Product Measure of Performance; defined as the number of problems attempted and number of problems solved correctly) at 30 minutes post-dose and at 3 hours post-dose. The PERMP-C is designed to assess compliance and academic productivity in school children. It is a 10-minute timed test in which the number of problems attempted and correct are assessed prior to and after an intervention. Scoring is based on problems attempted and correct. An increase in numerical score is indicative of improvement.

Outcome measures

Outcome measures
Measure	Active Treatment n=18 Participants Double blind amphetamine extended-release oral suspension, 2.5 mg/mL, 6, 7 or 8 mL po QAM amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO Placebo extended-release oral suspension: 6, 7 or 8 mL PO	Placebo Treatment n=18 Participants Double blind placebo, 6, 7 or 8 mL po QAM amphetamine extended-release oral suspension, 2.5 mg/mL: 5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO Placebo extended-release oral suspension: 6, 7 or 8 mL PO
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly) Change from predose in PERMP-C at 3 hours	52.4 Change from baseline in PERMP score Standard Error 9.43	-7.9 Change from baseline in PERMP score Standard Error 9.43
Change in Permanent Product Measure of Performance (PERMP-C) Score (Problems Answered Correctly) Change from predose in PERMP-C at 30 minutes	14.4 Change from baseline in PERMP score Standard Error 7.25	-4.7 Change from baseline in PERMP score Standard Error 7.25

Adverse Events

AMPH EROS: Open Label Phase

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Crossover Phase: AMPH EROS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crossover Phase: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AMPH EROS: Open Label Phase n=18 participants at risk All AEs reported are from the open-label dose optimization phase with AMPH EROS. The open-label dose optimization phase preceded the crossover portion of the study.	Crossover Phase: AMPH EROS n=18 participants at risk These AEs occurred during the crossover phase of the study.	Crossover Phase: Placebo n=18 participants at risk These AEs occurred during the crossover phase of the study.
Infections and infestations Upper respiratory tract infection	22.2% 4/18 • Number of events 6 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Infections and infestations Bronchitis	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Infections and infestations Respiratory tract viral infection	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Gastrointestinal disorders Abdominal pain, upper	11.1% 2/18 • Number of events 2 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
General disorders Fatigue	16.7% 3/18 • Number of events 3 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Nervous system disorders Headache	11.1% 2/18 • Number of events 2 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Nervous system disorders Motion sickness	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Metabolism and nutrition disorders Decreased appetite	11.1% 2/18 • Number of events 2 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Psychiatric disorders Affect lability	11.1% 2/18 • Number of events 2 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Psychiatric disorders Constricted affect	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Eye disorders Visioned blurred	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)
Respiratory, thoracic and mediastinal disorders Cough	5.6% 1/18 • Number of events 1 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)	0.00% 0/18 • The duration of the study (5 weeks from screening to final follow-up assessment)

Additional Information

Antonio Pardo MD

Tris Pharma, Inc.

Phone: 16107502210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place