NCT03337646

Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

Completed Phase 4 Last updated 12 February 2024

What this trial tests

Phase 4 trial testing Lisdexamfetamine Dimesylate in Attention Deficit Hyperactivity Disorder in 48 participants. Completed in 31 March 2023.

Timeline

26 September 2018

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	JPM van Stralen Medicine Professional
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	26 September 2018
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across Canada

Drugs / interventions tested

• Lisdexamfetamine Dimesylate — full drug profile →

Conditions studied

• Attention Deficit Hyperactivity Disorder — all drugs for Attention Deficit Hyperactivity Disorder →
• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

JPM van Stralen Medicine Professional — full company profile →

Who can join

Adults 6 to 12, any sex, with Attention Deficit Hyperactivity Disorder or Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 with ADHD and comorbid Autism Spectrum Disorder (ASD). This would be a novel study as there is no known safety or efficacy data for amphetamine based medications in this population. In addition, although health related quality of life and executive function are known to improve with the treatment of lisdexamfetamine dimesylate in the ADHD population (Banaschewski 2013; Findling 2009; Turgay 2010), it has not been shown in the co-morbid ADHD and ASD population. ADHD is the most common pediatric neurobiological condition affecting approximately five percent of the pediatric population (Feldman 2009). ASD is being increasingly recognized as affecting a substantial amount of the pediatric population, with recent prevalence data showing 1 in 68 affected (Baio, 2014). Prior to the introduction of DSM-5 (APA, 2013), exclusion criteria precluded the diagnosis of ADHD when ASD was present. Studies have shown that 41%-71% of children with ASD also meet criteria for ADHD (Goldstein 2004, Sturm 2004,Yoshida 2004, Gadow 2006). This means that up to 1% of the population may have co-morbid ADHD and ASD. With the official recognition of this comorbidity, treatment of comorbid ADHD when ASD is also present has been increasingly recognized as an important strategy in improving executive functioning and quality of life in those affected. Studies have indicated that some of the medications commonly used to treat ADHD, are effective and safe when used in comorbid ADHD and ASD. At this time, there have been well designed studies demonstrating safety and efficacy for methylphenidate (Ghuman et al. 2009; Handen et al. 2000; Quintana et al. 1995; RUPP 2005), guanfacine XR (Posey 2004; Scahill 2015), and atomoxetine (Arnold 2006; Harfterkamp 2012).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.