Phase 4
Completed N=97
Crossover Study to Evaluate the Efficacy of AR11 in Pediatric Patients With ADHD in a Laboratory Classroom Setting
Source: ClinicalTrials.gov NCT01986062 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: SKAMP-Combined Scores — 10.0; 17.8 units on a scale — p=<0.0001
◆ Published Evidence
Established
26citations · ~2 / year
The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study.
Summary
This is a dose-optimized, randomized, double-blind, placebo-controlled crossover study in approximately 100 pediatric patients (aged 6 to 12 years) with ADHD. Eligible patients will enroll to take open-label AR11 BID and undergo dose optimization activities for 8 weeks. Patients who achieve a stable dose during the dose optimization period will continue participation and will be randomized to take double-blind medication (AR11 or placebo) orally twice daily for 1 week. At the end of each double-blind treatment period, patients will be evaluated for ADHD symptoms in a laboratory classroom setting utilizing SKAMP and PERMP assessments.
Linked Publications (2)
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The Efficacy and Safety of Evekeo, Racemic Amphetamine Sulfate, for Treatment of Attention-Deficit/Hyperactivity Disorder Symptoms: A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled Crossover Laboratory Classroom Study.
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Gender Effects in the Efficacy of Racemic Amphetamine Sulfate in Children with Attention-Deficit/Hyperactivity Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SKAMP-Combined Scores |
11.8; 17.3; 11.6; 19.8; 14.5; 20.2 | <0.0001 sig |
| SECONDARY SKAMP-Combined Scores |
11.8; 17.3; 11.6; 19.8; 14.5; 20.2 | <0.0001 sig |
| SECONDARY SKAMP Subscale - Attention Scores |
2.2; 3.4; 1.9; 3.4; 2.2; 4.0 | <0.0001 sig |
| SECONDARY SKAMP Subscale - Deportment Scores |
2.1; 3.9; 1.6; 4.0; 2.1; 4.7 | <0.0001 sig |
| SECONDARY PERM-P Scores - Number of Problems Attempted |
111.6; 91.2; 113.4; 85.7; 113.2; 85.1 | <0.0001 sig |
| SECONDARY PERM-P Scores - Number of Problems Correct |
104.5; 83.9; 107.1; 78.9; 107.0; 79.9 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female between 6 and 12 years of age, inclusive, at the time of Screening.
- Diagnosed as meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for ADHD.
- A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater.
- An ADHD Rating Scale (ADHD-RS) score at Screening and Baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: hyperactive-impulsive subscale, inattentive subscale, or total score.
Exclusion Criteria
- Secondary or co-morbid diagnoses other than ADHD, with the exception of simple phobias, oppositional defiant disorder, elimination disorders, motor skills disorders, communication disorders, learning disorders, adjustment disorders, and sleep disorders if, in the opinion of the investigator, the associated symptoms do not confound assessment of safety or efficacy.
- Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator.
- History of any of the following medical disorders: seizure disorder (excluding a history of febrile seizures), structural cardiac disorders, serious cardiac conditions, hypertension, untreated thyroid disease, glaucoma, Tourette's disorder, or chronic tics.
- Clinically significant abnormal ECG finding or abnormal cardiac finding on physical exam (including presence of a pathologic murmur) at Screening.
- Use of any psychotropic medication (sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to Baseline, at bedtime only, are allowed during the study).
- A history of hypersensitivity or intolerance to any formulation of amphetamine or lisdexamfetamine.
Data sourced from ClinicalTrials.gov (NCT01986062) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.