Lisdexamfetamine

Generic Name: Lisdexamfetamine

Brand Names: Vyvanse

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₅N_₃O

CAS Number: 608137-32-2

Unique Ingredient Identifier: H645GUL8KJ

Background: Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system stimulant known as d-amphetamine, covalently attached to the naturally occurring amino acid L-lysine. Lisdexamfetamine is the first chemically formulated prodrug stimulant and was first approved by the FDA in April 2008. It was also approved by Health Canada in February 2009. Lisde...

Indication: Lisdexamfetamine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients six years and older. It is also indicated to treat moderate to severe binge eating disorder (BED) in adults. It is approved for use in the US and Canada.

Associated Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Moderate Binge Eating Disorder (BED), Severe Binge Eating Disorder (BED)

Associated Therapies: -

Clinical Trials

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

Not Applicable

Terminated

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: Lisdexamfetamine
Drug: Guanfacine

First Posted Date: 2014-10-08

Last Posted Date: 2023-02-02

Lead Sponsor: New York State Psychiatric Institute

Target Recruit Count: 38

Registration Number: NCT02259517

Locations: 🇺🇸
New York State Psychiatric Institute, New York, New York, United States

Lisdexamfetamine's Effect In ADHD in the Brain and Cognition

Phase 4

Terminated

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: Lisdexamfetamine

First Posted Date: 2014-06-23

Last Posted Date: 2019-12-26

Lead Sponsor: University of California, Davis

Target Recruit Count: 6

Registration Number: NCT02170298

Locations: 🇺🇸
UC Davis MIND Institute, Sacramento, California, United States

Clinical Efficacy of Lisdexamfetamine for Methamphetamine Dependence

Phase 1

Completed

Conditions: Methamphetamine Dependence

Interventions: Drug: Placebo
Drug: Lisdexamfetamine

First Posted Date: 2014-01-13

Last Posted Date: 2017-08-22

Lead Sponsor: University of Arkansas

Target Recruit Count: 19

Registration Number: NCT02034201

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Phase 3

Completed

Conditions: Binge Eating Disorder

Interventions: Other: Placebo
Drug: Lisdexamfetamine dimesylate

First Posted Date: 2013-12-11

Last Posted Date: 2021-06-14

Lead Sponsor: Shire

Target Recruit Count: 418

Registration Number: NCT02009163

Locations: 🇺🇸
Gulfcoast Clinical Research Center, Fort Myers, Florida, United States
🇺🇸
Cypress Medical Research Center, Wichita, Kansas, United States
🇺🇸
McLean Hospital, Belmont, Massachusetts, United States

and more 47 locations

E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy

Not Applicable

Withdrawn

Conditions: Planned RRSO

Interventions: Drug: Placebo
Drug: Estradiol
Drug: Lisdexamfetamine

First Posted Date: 2013-11-18

Last Posted Date: 2017-03-24

Lead Sponsor: University of Pennsylvania

Registration Number: NCT01986764

Locations: 🇺🇸
Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania, United States

LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy

Not Applicable

Withdrawn

Conditions: Cognitive Impairments
RRSO

Interventions: Drug: Placebo
Drug: lisdexamfetamine

First Posted Date: 2013-11-18

Last Posted Date: 2017-09-18

Lead Sponsor: University of Pennsylvania

Registration Number: NCT01986777

Locations: 🇺🇸
Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania, United States

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Phase 4

Completed

Conditions: Menopause
Brain Activity
Cognition

Interventions: Other: Placebo
Drug: Lisdexamfetamine

First Posted Date: 2013-11-06

Last Posted Date: 2018-07-27

Lead Sponsor: University of Pennsylvania

Target Recruit Count: 18

Registration Number: NCT01977625

Locations: 🇺🇸
University of Pennsylvania, Penn Center for Womens Behavioral Wellness, Philadelphia, Pennsylvania, United States

Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation

Phase 4

Completed

Conditions: ADHD

Interventions: Drug: Lisdexamfetamine

First Posted Date: 2013-08-16

Last Posted Date: 2018-06-06

Lead Sponsor: Jeffrey Newcorn

Target Recruit Count: 30

Registration Number: NCT01924429

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States

Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Lisdexamfetamine Dimesylate

First Posted Date: 2013-07-02

Last Posted Date: 2021-06-03

Lead Sponsor: Shire

Target Recruit Count: 30

Registration Number: NCT01890785

Locations: 🇺🇸
Clinical Pharmacology of Miami, Inc, Miami, Florida, United States

Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity

Phase 4

Completed

Conditions: Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders

Interventions: Drug: placebo
Drug: Lisdexamfetamine Dimesylate

First Posted Date: 2013-05-29

Last Posted Date: 2017-08-02

Lead Sponsor: Centre for Anxiety, Attention Deficit and Trauma, Ontario, Canada

Target Recruit Count: 42

Registration Number: NCT01863459

Locations: 🇨🇦
Centre for Anxiety, Attention Deficit and Trauma, Hamilton, Ontario, Canada

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

© Copyright 2024. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy