Study Summary
This trial will test the effect of Lisdexamfetamine dimesylate on children and adolescents with ADHD and comorbid Autism Spectrum Disorder.
Eligible Conditions
- Autism
- Attention Deficit Hyperactivity Disorder (ADHD)
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: 12 weeks
12 weeks
ADHD Symptoms
Executive Function
Health Related Quality of Life
Improvement of Subjects
Safety - suicidality
Safety-Adverse events
Severity of illness
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
0 Treatment Group
40 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Who is running the clinical trial?
ShireIndustry Sponsor
455 Previous Clinical Trials
93,049 Total Patients Enrolled
JPM van Stralen Medicine ProfessionalLead Sponsor
2 Previous Clinical Trials
79 Total Patients Enrolled
Judy van Stralen, MDPrincipal InvestigatorCenter for Pediatric Excellence
1 Previous Clinical Trials
29 Total Patients Enrolled
Eligibility Criteria
Age 6 - 12 · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Center for Pediatric Excellence | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How many prior treatments have patients received?
| 3+ | 100.0% |
References
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- Bolte S, Willfors C, Berggren S, Norberg J, Poltrago L, Mevel K, Coco C, Fransson P, Borg J, Sitnikov R, Toro R, Tammimies K, Anderlid BM, Nordgren A, Falk A, Meyer U, Kere J, Landen M, Dalman C, Ronald A, Anckarsater H, Lichtenstein P. The Roots of Autism and ADHD Twin Study in Sweden (RATSS). Twin Res Hum Genet. 2014 Jun;17(3):164-76. doi: 10.1017/thg.2014.12. Epub 2014 Apr 15.
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- Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007 Mar;29(3):450-63. doi: 10.1016/s0149-2918(07)80083-x.
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- Goldstein S, Schwebach AJ. The comorbidity of Pervasive Developmental Disorder and Attention Deficit Hyperactivity Disorder: results of a retrospective chart review. J Autism Dev Disord. 2004 Jun;34(3):329-39. doi: 10.1023/b:jadd.0000029554.46570.68.
- Davis NO, Kollins SH. Treatment for co-occurring attention deficit/hyperactivity disorder and autism spectrum disorder. Neurotherapeutics. 2012 Jul;9(3):518-30. doi: 10.1007/s13311-012-0126-9.
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- Posey DJ, Puntney JI, Sasher TM, Kem DL, McDougle CJ. Guanfacine treatment of hyperactivity and inattention in pervasive developmental disorders: a retrospective analysis of 80 cases. J Child Adolesc Psychopharmacol. 2004 Summer;14(2):233-41. doi: 10.1089/1044546041649084.
- Brown K. Neuroscience. New attention to ADHD genes. Science. 2003 Jul 11;301(5630):160-1. doi: 10.1126/science.301.5630.160. No abstract available.
- Faraone SV. Lisdexamfetamine dimesylate: the first long-acting prodrug stimulant treatment for attention deficit/hyperactivity disorder. Expert Opin Pharmacother. 2008 Jun;9(9):1565-74. doi: 10.1517/14656566.9.9.1565.
- Leitner Y. The co-occurrence of autism and attention deficit hyperactivity disorder in children - what do we know? Front Hum Neurosci. 2014 Apr 29;8:268. doi: 10.3389/fnhum.2014.00268. eCollection 2014.
- Hazlett HC, Poe M, Gerig G, Smith RG, Provenzale J, Ross A, Gilmore J, Piven J. Magnetic resonance imaging and head circumference study of brain size in autism: birth through age 2 years. Arch Gen Psychiatry. 2005 Dec;62(12):1366-76. doi: 10.1001/archpsyc.62.12.1366.
- Dr. Judy van Stralen 2018. "Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03337646.
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