Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764868
• Other study ID #: SPD489-306
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2008
• Est. completion date: April 22, 2010

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Not Required

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: April 22, 2010
• Est. primary completion date: April 22, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Future Search Trials	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Florida Clinical Research Center, LLC	Bradenton	Florida
United States	Vermont Clinical Study Center	Burlington	Vermont
United States	University Hospitals of Cleveland Division of Child & Adolescent Psychiatry	Cleveland	Ohio
United States	Triangle Neuropsychiatry, PLLC	Durham	North Carolina
United States	Valley Clinical Research, Inc.	El Centro	California
United States	OCCI	Eugene	Oregon
United States	Innovis Health/Odyssey Research	Fargo	North Dakota
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Neuroscience, Inc.	Herndon	Virginia
United States	Amedica Research Institute, Inc.	Hialeah	Florida
United States	Bayou City Research, Ltd.	Houston	Texas
United States	Red Oak Psychiatry Associates P.A.	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada
United States	Capstone Clinical Research	Libertyville	Illinois
United States	Clinical Study Centers, LLC	Little Rock	Arkansas
United States	Northwest Behavioral Research Center	Marietta	Georgia
United States	CNS Healthcare	Memphis	Tennessee
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Bioscience Research, LLC	Mount Kisco	New York
United States	Louisiana Research Associates, Inc.	New Orleans	Louisiana
United States	CIENTIFICA, Inc. at Prairie View	Newton	Kansas
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Psychiatric Associates	Overland Park	Kansas
United States	Vince and Associates Clinical Research, Inc.	Overland Park	Kansas
United States	Pedia Research LLC.	Owensboro	Kentucky
United States	Four Rivers Clinical Research, Inc.	Paducah	Kentucky
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	Youth and Family Research Program/WPIC ADHD Research Program	Pittsburgh	Pennsylvania
United States	Summit Research Network	Portland	Oregon
United States	Penninsula Research Associates, Inc.	Rolling Hills Estates	California
United States	OCCI, INC (Oregon Center for Clinical Investigations, Inc.)	Salem	Oregon
United States	ADHD Clinic of San Antonio	San Antonio	Texas
United States	Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)	San Diego	California
United States	Miami Research Associates	South Miami	Florida
United States	Clinco Inc.	Terre Haute	Indiana
United States	Children's Specialized Hospital	Toms River	New Jersey
United States	Bart Sangal	Troy	Michigan
United States	Janus Center for Psychiatric Research	West Palm Beach	Florida
United States	Elite Clinical Trials, Inc.	Wildomar	California
United States	Neuropsychiatric Associates	Woodstock	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Findling RL, Cutler AJ, Saylor K, Gasior M, Hamdani M, Ferreira-Cornwell MC, Childress AC. A long-term open-label safety and effectiveness trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.	Baseline and up to 52 weeks
Secondary	Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	up to 52 weeks
Secondary	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	The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.	Baseline and Up to 52 weeks