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Central Nervous System Stimulant

Lisdexamfetamine for ADHD

Phase 4
Waitlist Available
Led By Judy van Stralen, MD
Research Sponsored by JPM van Stralen Medicine Professional
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up12 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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 Spectrum Disorder
  • Autism
  • Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have been diagnosed with autism based on your history and a test called the Autism Diagnostic Observation Scale (ADOS-2).
Your SRS-2 total score is 70 or higher.
Your doctor has assessed your illness as moderate or severe.
Your blood pressure is higher than what is considered normal for someone your age and sex.
You have been diagnosed with ADHD and have specific scores on two different tests.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD Symptoms
Secondary outcome measures
Executive Function
Health Related Quality of Life
Improvement of Subjects
+3 more

Side effects data

From 2011 Phase 4 trial • 26 Patients • NCT01071044
Dry Mouth
Decreased Appetite
Facial Tics
Muscle Aches
Urinary Tract Infection
Weight Loss
Study treatment Arm
Treatment Group
Control Group

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LisdexamphetamineExperimental Treatment1 Intervention
All participants will receive Lisdexamfetamine Dimesylate (LDX) at an optimized dose based on protocol
First Studied
Drug Approval Stage
How many patients have taken this drug
Lisdexamfetamine Dimesylate
Completed Phase 4

Find a Location

Who is running the clinical trial?

ShireIndustry Sponsor
456 Previous Clinical Trials
98,162 Total Patients Enrolled
JPM van Stralen Medicine ProfessionalLead Sponsor
2 Previous Clinical Trials
91 Total Patients Enrolled
Judy van Stralen, MDPrincipal InvestigatorCenter for Pediatric Excellence
1 Previous Clinical Trials
41 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open for this clinical experiment?

"Affirmative. According to data hosted on clinicaltrials.gov, this medical research is presently seeking volunteers and was initially posted in September of 2018. The most recent update occurred at the end of March 2021 with 40 patients needed from 1 site."

Answered by AI

How many participants are being included in this medical experiment?

"Affirmative. Data from clinicaltrials.gov indicates that this study, which was initially made available on September 26th 2018, is actively recruiting volunteers. Approximately 40 people are needed to be sourced at a single medical site."

Answered by AI

Is this endeavor the pioneering study of its type?

"Research into this therapeutic option has been ongoing since 2018, beginning with an initial trial sponsored by Shire. This clinical study was successful enough to warrant Phase 4 drug approval and today there are 6 active trials occurring across 3 cities in 3 different countries."

Answered by AI

Has this therapeutic approach been tested in similar scenarios?

"Presently, 6 different medical trials are underway studying this intervention with 3 of them in their final stage. In addition to Iowa City, Iowa there are 5 other locations conducting clinical studies for the treatment."

Answered by AI

Is the cut-off age for this experiment 55 years old or younger?

"To be included in this trial, participants must have an age between 6 to 12. According to the data, there are 519 trials conducted for patients below 18 years old and another 681 clinical studies designed for elderly people above 65."

Answered by AI

What potential adverse effects could be experienced by those undergoing this treatment?

"By virtue of being a Phase 4 trial, the safety of this medical intervention is estimated to be 3 on our 1-3 scale. This indicates that there is ample evidence to support its approval for use."

Answered by AI

Do I meet the criteria to enroll in this clinical trial?

"To be eligible for this research, those with autism spectrum disorder must fall between the ages of 6 to 12. The team are expecting 40 people to join their investigation."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Center for Pediatric Excellence
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
Recent research and studies
~1 spots leftby Dec 2023