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Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD

Intervention: Lisdexamfetamine Dimesylate (LDX) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Robert Findling, M.D., Principal Investigator, Affiliation: University Hospitals of Cleveland Division of Child & Adolescent Psychiatry

Summary

The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70 mg/day) in the treatment of adolescents (13-17 years of age inclusive at the time of consent).

Clinical Details

Official title: A Phase III, Open-Label, Extension, Multi-Center, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks

Secondary outcome:

Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)

Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks

Detailed description: Not Required

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion 1. Subject is a male or female aged 13-17 years inclusive at the time of consent of the antecedent study (SPD489-305). 2. Subject satisfied all entry criteria for the antecedent study (SPD489-305), and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events (AEs) that would preclude exposure to LDX. Exclusion 1. Subject was terminated from SPD489-305 for non-compliance and/or experienced a serious adverse event (SAE) or AE resulting in termination from the antecedent study (SPD489-305). 2. 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 (such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations, such as agitated states, marked anxiety, or tension that, in the opinion of the examining clinician, will contraindicate treatment with LDX or confound efficacy or safety assessments. Comorbid psychiatric diagnoses will be

established at the Screening Visit (Visit - 1) of the antecedent study (SPD489-305)

with the Screening interview of the Kiddie-SADS-Present and Lifetime - Diagnostic

Interview (K-SADS-PL) and additional modules if warranted by the results of the initial interview. Participation in behavioral therapy, provided the subject was receiving the therapy for at least 1 month at the time of the Baseline Visit (Visit 0) of the antecedent study (SPD489-305). 3. Subject has a conduct disorder. Oppositional Defiant Disorder is not exclusionary. 4. Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation. 5. Subject is underweight based on Center for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts at the Enrollment Visit (Visit 1) of this study. Underweight is defined as a BMI < 5th percentile. 6. Subject has a concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol. 7. Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder. 8. Subject has a known history symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. 9. Subject has a known family history of sudden cardiac death or ventricular arrhythmia. 10. Subject has any clinically significant ECG, based on the Principal Investigator's judgment, at Visit 4/ET of the antecedent study (SPD489-305). 11. Subject is taking any medication that is excluded. 12. Subject has a documented allergy, hypersensitivity or intolerance to amphetamine. 13. Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria. 14. Subject has glaucoma. 15. Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary. 16. Subject is female and is pregnant or lactating.

Locations and Contacts

Clinical Study Centers, LLC, Little Rock, Arkansas 72205, United States

Valley Clinical Research, Inc., El Centro, California 92243, United States

Penninsula Research Associates, Inc., Rolling Hills Estates, California 90274, United States

Psychiatric Centers at San Diego (PCSD-Feighner Research Institute), San Diego, California 92108, United States

Elite Clinical Trials, Inc., Wildomar, California 92595, United States

Florida Clinical Research Center, LLC, Bradenton, Florida 34208, United States

Sarkis Clinical Trials, Gainsville, Florida 32607, United States

Amedica Research Institute, Inc., Hialeah, Florida 33013, United States

Clinical Neuroscience Solutions, Inc., Jacksonville, Florida 32216, United States

Clinical Neuroscience Solutions, Inc., Orlando, Florida 32806, United States

Miami Research Associates, South Miami, Florida 33143, United States

Janus Center for Psychiatric Research, West Palm Beach, Florida 33407, United States

Atlanta Center for Medical Research, Atlanta, Georgia 30308, United States

Northwest Behavioral Research Center, Marietta, Georgia 30060, United States

Capstone Clinical Research, Libertyville, Illinois 60048, United States

Clinco Inc., Terre Haute, Indiana 47802, United States

CIENTIFICA, Inc. at Prairie View, Newton, Kansas 67114, United States

Psychiatric Associates, Overland Park, Kansas 66211, United States

Vince and Associates Clinical Research, Inc., Overland Park, Kansas 66212, United States

Pedia Research LLC., Owensboro, Kentucky 42301, United States

Four Rivers Clinical Research, Inc., Paducah, Kentucky 42003, United States

Louisiana Research Associates, Inc., New Orleans, Louisiana 70114, United States

Bart Sangal, Troy, Michigan 48085, United States

Center for Psychiatry and Behavioral Medicine, Inc., Las vegas, Nevada 89128, United States

Children's Specialized Hospital, Toms River, New Jersey 08755, United States

Bioscience Research, LLC, Mount Kisco, New York 10549, United States

Triangle Neuropsychiatry, PLLC, Durham, North Carolina 27707, United States

Innovis Health/Odyssey Research, Fargo, North Dakota 58104, United States

University Hospitals of Cleveland Division of Child & Adolescent Psychiatry, Cleveland, Ohio 44106, United States

IPS Research Company, Oklahoma City, Oklahoma 73103, United States

OCCI, Eugene, Oregon 97401, United States

Summit Research Network, Portland, Oregon 97210, United States

OCCI, INC (Oregon Center for Clinical Investigations, Inc.), Salem, Oregon 97301, United States

CRI Worldwide, Philadelphia, Pennsylvania 19139, United States

Youth and Family Research Program/WPIC ADHD Research Program, Pittsburgh, Pennsylvania 15213, United States

CNS Healthcare, Memphis, Tennessee 38119, United States

Future Search Trials, Austin, Texas 78756, United States

Bayou City Research, Ltd., Houston, Texas 77007, United States

Red Oak Psychiatry Associates P.A., Houston, Texas 77090, United States

ADHD Clinic of San Antonio, San Antonio, Texas 78247, United States

Vermont Clinical Study Center, Burlington, Vermont 05401, United States

Neuropsychiatric Associates, Woodstock, Vermont 05091, United States

Neuroscience, Inc., Herndon, Virginia 20170, United States

Dominion Clinical Research, Midlothian, Virginia 23112, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Additional Information

Starting date: October 2008
Last updated: January 10, 2014

Page last updated: August 23, 2015

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