Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00764868
First received: September 29, 2008
Last updated: January 10, 2014
Last verified: January 2014

September 29, 2008
January 10, 2014
October 2008
April 2010   (final data collection date for primary outcome measure)
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 [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
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.
Safety based on TEAEs, BP and pulse, ECGs, clinical laboratory test results,and physical exam findings. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00764868 on ClinicalTrials.gov Archive Site
  • Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    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.
  • 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 [ Time Frame: Baseline and Up to 52 weeks ] [ Designated as safety issue: No ]
    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.
ADHD-RS-IV, CGI-I, YQOL-R [ Time Frame: The ADHD-RS-IV and CGI will be administered at every visit starting at Visit 1. The YQOL-R will be administered at Visit 11 and 17. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study
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)

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).

Not Required

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
ADHD
Drug: Lisdexamfetamine Dimesylate (LDX)
optimal dose of 30, 50 or 70 mg once daily
Other Name: Vyvanse
Experimental: LDX
Lisdexamfetamine Dimesylate (LDX)
Intervention: Drug: Lisdexamfetamine Dimesylate (LDX)
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 Psychopharmacol. 2013 Feb;23(1):11-21. doi: 10.1089/cap.2011.0088.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
269
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
13 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00764868
SPD489-306
No
Shire
Shire
Not Provided
Principal Investigator: Robert Findling, M.D. University Hospitals of Cleveland Division of Child & Adolescent Psychiatry
Shire
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP