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Open-Label, Extension, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
This study is not yet open for participant recruitment.
Verified by Shire Pharmaceutical Development, November 2008
Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00784654
  Purpose

The main aim of this study is to evaluate the safety of LDX when administered to children and adolescents aged 6-17 with ADHD for 52 weeks


Condition Intervention Phase
ADHD
Drug: LDX
Phase III

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:
  • Adverse Events and Vital Signs [ Time Frame: Weekly for the first 4 weeks of treatment; monthly for the final 48 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Clinical Laboratory Results [ Time Frame: Week 20 amd Week 52 ] [ Designated as safety issue: Yes ]
  • ECGs [ Time Frame: Week 12, Week 24, Week 36 and Week 52 ] [ Designated as safety issue: Yes ]
  • Discontinuations [ Time Frame: Throughout the 52-week study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy using the ADHD-RS and CGI-I scales and Health Outcomes using the WFIRS-P, CHIP-CE/PRF, HUI-2 scales [ Time Frame: ADHD-RS and CGI-I weekly for the first 4 weeks of treatment and monthly for the final 48 weeks of treatment; WFIRS-P, CHIP-CE/PRF, and HUI-2 at Weeks 8, 24, 36, and 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 238
Study Start Date: November 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LDX: Experimental
Open-label LDX 30, 50, or 70mg
Drug: LDX
LDX 30, 50, or 70mg capsule once per day

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects parent or legally authorised representative(LAR) must provide signature of informed consent, and there must be documentation of assent (if applicable) by the subject indicating that the subject is aware of the investigational nature of the study and the required procedures and restrictions in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations before completing any study-related procedures.
  • Subject and parent or LAR are willing and able to comply with all the testing and requirements defined in this protocol, including oversight of morning dosing. Specifically, the parent or LAR must be available upon awakening, at approximately 7:00AM, to dispense the dose of test product for the duration of the study.
  • Subject is a male or female aged 6-17 years inclusive at the time of consent for the antecedent study SPD489-325.
  • Subject satisfied all entry criteria for the antecedent study SPD489-325, and completed a minimum of 4 weeks of double-blind treatment, reached Visit 4 and completed the 1-week post-treatment washout in the antecedent study SPD489-325, without experiencing any clinically significant AEs that would preclude exposure to LDX.
  • Subject has blood pressure measures within the 95th percentile for age, gender, and height.

Exclusion Criteria:

  • Subject was terminated from SPD489-325 for non-compliance and or experienced an SAE or AE resulting in termination from the antecedent study.
  • 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. Participation in behavioural 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 SPD489-325.
  • Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.
  • Subject is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently, demonstrating active suicidal ideation.
  • Subject is female and is pregnant or lactating.
  • Subject has glaucoma.
  • Subject has any clinically significant ECG at Visit 8 of the antecedent study SPD489-325 or clinically significant laboratory abnormalities at Visit 7 of the antecedent study SPD489-325.
  • Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine.
  • Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine).
  • Subject has a history of seizures (other than infantile febrile seizures), a tic disorder, a current diagnosis and or a known family history of Tourette's Disorder.
  • Subject has a known history of 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.
  • Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  • Subject is taking any medication that is excluded.
  • Subject is taking other medications that have central nervous system (CNS) effects, affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors (during or within 14 days of test product administration). Stable use of bronchodilator inhalers is not exclusionary.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784654

Contacts
Contact: Shire Call Center Shire Call Center +1 866 842 5335

Sponsors and Collaborators
Shire Pharmaceutical Development
  More Information

Responsible Party: Shire Pharmaceuticals ( Timothy Whitaker, MD )
Study ID Numbers: SPD489-326
Study First Received: November 3, 2008
Last Updated: November 3, 2008
ClinicalTrials.gov Identifier: NCT00784654  
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Belgium: Federal Agency for Medicinal Products and Health Products;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Spain: Spanish Agency of Medicines;   Sweden: Medical Products Agency

Study placed in the following topic categories:
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Dextroamphetamine
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009