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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

Timeline

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

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You have been diagnosed with autism based on your history and a test called the Autism Diagnostic Observation Scale (ADOS-2).

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Your SRS-2 total score is 70 or higher.

Select...

Your doctor has assessed your illness as moderate or severe.

Select...

Your blood pressure is higher than what is considered normal for someone your age and sex.

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You have been diagnosed with ADHD and have specific scores on two different tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

27%

Headaches

13%

Dry Mouth

13%

Insomnia

Decreased Appetite

Facial Tics

Muscle Aches

Nausea

Tinnitus

Urinary Tract Infection

Weight Loss

Anxiety

100%

80%

60%

40%

20%

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lisdexamfetamine Dimesylate

2013

Completed Phase 4

~670

0 / 5Eligibility criteria met

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