Lisdexamfetamine Dimesylate 2-year Safety Study in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01328756
First received: March 29, 2011
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

While the Lisdexamfetamine Dimesylate (SPD489) clinical program has studied the efficacy, safety, and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 years and adults aged 18-55 years, the majority of these studies have been of short duration - up to 8 weeks.

A number of long-term studies have been undertaken (up to 1 year) and these have confirmed the safety and ongoing efficacy in this patient population.

In order to run a study with investigational medication within Poland the study changed to a Phase 3 rather than a Phase 4 study in that country. Please note that the study number remains as SPD489-404.

Study SPD489-404 has been designed to further evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder (ADHD)
Drug: Lisdexamfetamine dimesylate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 4, Open-Label, Multicentre, Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Psychiatric symptom severity scores on Brief Psychiatric Rating Scale for Children (BPRS-C) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Occurrence of treatment-emergent adverse events (TEAEs) as a measure of safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement (CGI-I) Rating Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity of Illness (CGI-S) Rating Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine Dimesylate Drug: Lisdexamfetamine dimesylate
Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
Other Name: Vyvanse, SPD489, LDX

  Eligibility

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

Inclusion Criteria:

For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):

  • Subject is a male or female aged 6-17 years.
  • Subject participated in SPD489-317, completed 9 weeks of treatment, and completed the 1 week post-treatment safety follow-up visit.

For subjects who have not participated in another SPD489 study:

  • Subject is a male or female aged 6-17 years.
  • Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.

For all subjects:

  • Subject has a Baseline ADHD-RS-IV total score greater than or equal to 28.
  • Subject, who is female of childbearing potential (FOCP), must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test, and a negative urine pregnancy test at Baseline, be non-lactating and agree to comply with any applicable contraceptive requirements of the protocol.
  • Subject and parent/LAR are willing and able to comply with all the testing and requirements defined, including oversight of morning dosing. Specifically, the parent/LAR must be available upon awakening, at approximately 7:00 AM, to dispense the dose of Investigational Product for the duration of the study.
  • Subject aged greater than or equal to 18 years has a systolic blood pressure less than or equal to 139 mmHg and a diastolic blood pressure less than or equal to 89 mmHg.
  • Subject is able to swallow a capsule.

Exclusion Criteria:

For subjects who participated in another SPD489 study (SPD489-317, SPD489-325, or SPD489 326):

  • Subject was terminated from a previous SPD489 study (SPD489-325 or SPD489 326) for protocol non-adherence and/or subject non-compliance and/or experienced a medication-related SAE or AE resulting in termination from the previous study.
  • Subject experienced any clinically significant AEs in a prior SPD489 study (SPD489 317, SPD489-325, or SPD489-326) that, in the opinion of the Investigator, would preclude further exposure to SPD489.

For all subjects:

  • Subject's symptoms are well-controlled on their currently prescribed ADHD medication with acceptable tolerability.
  • Subject has a positive urine drug result at Screening.
  • 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.
  • Subject has taken another Investigational Product or taken part in a clinical study with the exception of a prior SPD489 study (SPD489-317, SPD489 325, or SPD489 326) within 30 days prior to Screening.
  • Subject weighs less than 22.7 kg (50 lbs).
  • Subject is significantly overweight.
  • Subject has a conduct disorder. Oppositional defiant disorder is not exclusionary.
  • Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition that might confound the results of safety assessments conducted in the study or that might increase risk to the subject.
  • Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator
  • Subject has glaucoma.
  • Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
  • Subject has any clinically significant ECG abnormality.
  • Subject has any clinically significant laboratory abnormalities.
  • Subject has a documented allergy, hypersensitivity, or intolerance to any active ingredient or excipients in SPD489.
  • 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.
  • Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, a current diagnosis of Tourette's Disorder, or a known family history of Tourette's Disorder. Subject has a history of tics that is judged by the Investigator to be exclusionary.
  • Subject has a known history of symptomatic cardiovascular or cerebrovascular 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 has a medical condition, other than ADHD, that requires treatment with medications that have central nervous system effects and/or affect performance. Stable use of anticholinergic or theophylline bronchodilators is not exclusionary.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328756

  Show 35 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: David Coghill, Dr Tayside Children's Hospital
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01328756     History of Changes
Other Study ID Numbers: SPD489-404
Study First Received: March 29, 2011
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014