Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

NCT01106430 | Completed Phase 3 Results

• 2 other identifiers: SPD489-3172009-011745-94
• Study Type: interventional
• Target: 267
• Locations: 10 countries
• Sites: 64

Brief Summary

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Time to First Response

  Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).

  9 weeks

Secondary Outcomes (7)

• Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF)

  9 weeks

• Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF

  Baseline and 9 weeks

• Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks

  Baseline and up to 9 weeks

• Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks

  up to 9 weeks

• Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks

  Baseline and up to 9 weeks

Study Arms (2)

Lisdexamfetamine Dimesylate

EXPERIMENTAL

Drug: Lisdexamfetamine Dimesylate

Atomoxetine Hydrochloride

ACTIVE COMPARATOR

Drug: Atomoxetine Hydrochloride

Interventions

Lisdexamfetamine Dimesylate DRUG

Oral 30, 50, or 70mg once-daily for 9 weeks

Also known as: Vyvanse

Lisdexamfetamine Dimesylate

Atomoxetine Hydrochloride DRUG

Oral 10mg to 100mg once-daily for 9 weeks

Also known as: Strattera

Atomoxetine Hydrochloride

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject has had an historical or current inadequate response to methylphenidate (MPH) treatment. Inadequate response includes but is not limited to the presence of some residual symptoms, with associated impairment inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative drug treatment to MPH therapy.
• Subject is a male or female aged 6-17 years inclusive at the time of consent
• Subject must meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition. - Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation
• Subject must have a baseline ADHD-RS-IV total score 28.

You may not qualify if:

• Subject has taken more than 1 MPH treatment (for example, 2 or more different MPH treatments). Examples include but are not limited to RITALIN immediate release (IR) and EQUASYM IR; MEDIKINET IR and CONCERTA; RITALIN long-acting LA and CONCERTA. Note: this does not include subjects who have taken IR MPH for dose titration on a short-term basis (for example, £4 weeks) with an adequate response
• In the Investigator's judgement, subject has failed to respond to more than 1 previous course(s) of MPH treatment. Failure to respond includes worsening of symptoms or no change/minimal improvement of symptoms.
• Subject has previously been exposed to STRATTERA or to amphetamine therapy
• Subject has previously demonstrated intolerable side effects to 1 MPH treatment which limited titration to acceptable efficacy or that required a decrease in dose resulting in unacceptable tolerability and/or efficacy
• Subject has a current, controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any severe comorbid Axis II disorder or severe Axis I disorder or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining physician, will contraindicate treatment with SPD489 or STRATTERA or confound efficacy or safety assessments.

Sponsors & Collaborators

• Shire: lead

Study Sites (64)

Harmonex Neuroscience Research, Inc

Dothan, Alabama, 36303, United States

Location

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

Shanti Clinical Trials

Colton, California, 92324, United States

Location

Psychiatric Centers at San Diego Feighner Research

San Diego, California, 92108, United States

Location

Elite Clinical Trials, Inc.

Wildomar, California, 92595, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Amedica Research Institute, Inc.

Hialeah, Florida, 33013, United States

Location

Fidelity Clinical Research, Inc.

Lauderhill, Florida, 33319, United States

Location

Clinical Neuroscience Solutions, INC

Orlando, Florida, 32806, United States

Location

Northwest Behavioral Research Center

Roswell, Georgia, 30076, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Baber Psychiatric Associates

Naperville, Illinois, 60563, United States

Location

Clinco

Terre Haute, Indiana, 47802, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Four Rivers Clinical Research, Inc

Paducah, Kentucky, 42003, United States

Location

Louisianna Research Associates

New Orleans, Louisiana, 70114, United States

Location

Office of Marc Hertzman, MD, PC

Rockville, Maryland, 20852, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group/Saint Charles Psychiatric Associates

Saint Charles, Missouri, 63301, United States

Location

Premier Psychiatric Research Institute, LLC

Lincoln, Nebraska, 68526, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Children's Specialized Hospital

Toms River, New Jersey, 08755, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Triangle Neuropsychiatry, PLLC

Durham, North Carolina, 27707, United States

Location

Innovis Health

Fargo, North Dakota, 58103, United States

Location

IPS Research Company

Oklahoma City, Oklahoma, 73103, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

CRI Worldwide, LLC Kirkbride Division

Philadelphia, Pennsylvania, 19139, United States

Location

Future Search Clinical Trials

Austin, Texas, 78731, United States

Location

Red Oak Psychiatry Association, PA

Houston, Texas, 77090, United States

Location

Western Clinical Investigations

Lubbock, Texas, 79423, United States

Location

Cerebral Research, LLC

San Antonio, Texas, 78247, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

ZiekenhuisNetwerk Antwerpen

Hoboken, Antwerpen, 2660, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

Child and Adolescent Centre

Edmonton, Alberta, T6H 1P7, Canada

Location

Centre for Anxiety Attention Deficit and Trauma

Hamilton, Ontario, L8S 1B7, Canada

Location

AK Karan Holdings, Ltd.

Oakville, Ontario, L6J 0B2, Canada

Location

The Kids Clinic

Whitby, Ontario, L1N 8M7, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Albert-Ludwigs-Universitat Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Zentralinstitut für Seelische Gesundheit Mannheim

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Schwerpunktpraxis für Entwicklung und Lernen

Bamberg, Bavaria, 96047, Germany

Location

Medizinisches Studienzentrum Würzburg

Würzburg, Bavaria, 97070, Germany

Location

Klinikum Frankfurt/Oder

Frankfurt (Oder), Brandenburg, 15236, Germany

Location

Praxis Dr. Wolff

Hagen, North Rhine-Westphalia, 58093, Germany

Location

Szegedi Tudományegyetem Gyermek es lfjusagpszichlatrlai Osztaly

Szeged, Csongrád megye, 6720, Hungary

Location

Vadaskert Korhaz es Szakambulancia Gyermek es lfjusagpszichiatria

Budapest, Hungary

Location

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

Gyula, 5700, Hungary

Location

Gyermek- es lfjusagpszichiatriai Szakrendeles es Gondozo

Pécs, Hungary

Location

Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, 9124, Italy

Location

Katedra i Klinika Psychiatarii

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-096, Poland

Location

Samodzielny Publiczny Dzieciecy Szpital Kliniczny

Warsaw, Masovian Voivodeship, 00-576, Poland

Location

Hospital Son Llàtzer

Palma de Mallorca, Balearic Islands, 7198, Spain

Location

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Marítimo, Unidad de Salud Mental Infanto-Juvenil (USMI-J

Torremolinos, Malaga, 29620, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Location

Complejo Hospitalario Universitario de Badajoz

Badajoz, 6010, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 8036, Spain

Location

Drottning Silvias Barnsjukhus

Gothenburg, 411 18, Sweden

Location

Astrid Lindgren Children's Hospital/Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Basildon Hospital

Basildon, Essex, SS16 5NL, United Kingdom

Location

Tayside Children's Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (3)

• Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92. doi: 10.1007/s40263-013-0104-8.

  PMID: 23959815 RESULT

• Nagy P, Hage A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22.

  PMID: 25999292 DERIVED

• Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9.

  PMID: 25038977 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Propylamines

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 19, 2010
• Study Start: June 28, 2010
• Primary Completion: July 19, 2012
• Study Completion: July 19, 2012
• Last Updated: June 11, 2021
• Results First Posted: June 24, 2013

Record last verified: 2021-05

Locations

HU (4); PL (2); BE (2); DE (6); IT (1); ES (6); GB (2); CA (5); SE (2); US (34)