Status:
COMPLETED
Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
Lead Sponsor:
JPM van Stralen Medicine Professional
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effect and safety of Lisdexamfetamine dimesylate (Vyvanse®) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents...
Detailed Description
ADHD is the most common pediatric neurobiological condition affecting approximately five percent of the pediatric population (Faraone, Stephen V., Sergeant, J. et al. 2003; Feldman \& Belanger 2009). ...
Eligibility Criteria
Inclusion
- Male or female subject aged 6-12 years at the time of consent/assent.
- Subjects parent(s) or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject in accordance with the International Council on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 (1996), any updates or revisions, and applicable regulations, before completing any study related procedures.
- Subject and parent(s)/LAR are willing and able to comply with all of the requirements defined in the protocol.
- Subject meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for a diagnosis of ADHD combined presentation, inattentive presentation or hyperactive/impulsive presentation based on history and a minimum ADHD-RS score of 32 and a minimum CGI-S of 4 at baseline.
- Subject meets DSM-V criteria for a diagnosis of ASD-level 1 based on history and Autism Diagnostic Observation Scale (ADOS-2).
- Subject has an SRS-2 total score of ≥ 70.
- Subject has a Clinical Global Impressions - Severity of Illness (CGI-S) score ≥ 4 at the baseline visit (visit 2)
- Subject has a blood pressure measurement within 95th percentile for age, and sex (Appendix 1,1.1,2 \& 2.2). Subject and parent/legally authorized representative (LAR) are willing, able and likely to comply with the study procedures and restrictions within the protocol.
Exclusion
- Subject has any condition that, in the opinion of the investigator, represent an inappropriate risk to the subject or may confound the interpretation of the study.
- Subject has a known history or presence of structural cardiac abnormalities, cardiovascular or cerebrovascular disease, serious heart rhythm abnormalities, syncope, tachycardia, cardiac conduction problems (such as clinically significant heart block or QT interval prolongation), exercise-related cardiac events including syncope and pre-syncope or clinically significant bradycardia.
- Subject has a known history of symptomatic cardiovascular disease, unexplained syncope, exertional chest pain, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease or other serious cardiac problems placing them at increased vulnerability to sympathomimetic effects of a stimulant drug.
- Subject has a history of seizure disorder (other than a single childhood febrile seizure occurring before the age of 3 years).
- Subject has glaucoma.
- Subject is currently using prohibited medication.
- Subject has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to LDX.
- Subject has taken another investigational product within 30 day prior to baseline.
- Subject has initiated behavioural therapy within 1 month of the baseline visit (visit 0). Subject may not initiate behavioural therapy during the study.
- Subject is female and is pregnant or currently lactating.
- Subject is currently considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or has a prior history of or is currently demonstrating active suicide ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the investigator.
- History of failure to respond to an adequate trial of an amphetamine based medication.
- Subject is currently abusing an illicit substance or lives with someone known to currently abuse stimulants or cocaine..
- Subject has a known renal or hepatic insufficiency.
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03337646
Start Date
September 26 2018
End Date
March 31 2023
Last Update
February 12 2024
Active Locations (1)
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1
Center for Pediatric Excellence
Ottawa, Ontario, Canada, K2G1W2