Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase 4, Open Label, Multicentre, 2 Year Safety Study of Lisdexamfetamine Dimesylate in Children/Adolescents With ADHD (SPD489-404)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Information provided by:
Maastricht University Medical Center Identifier:
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

The purpose of this study is to evaluate the long-term effects of SPD489 in children and adolescents over a 2-year treatment period.

Condition Intervention Phase
Attention Deficit Disorder With Hyperactivity
Drug: Lisdexamfetamine dimesylate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Open-label, Multicentre, 2year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • ADHD rating scale IV [ Time Frame: two years ] [ Designated as safety issue: No ]
    to define subjects ADHD rating

Estimated Enrollment: 12
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lisdexamfetamine Drug: Lisdexamfetamine dimesylate
daily morning dose (30,50 and 70mg)
Other Name: SPD 489

Detailed Description:

While SPD 489 clinical program has studied the efficacy, safety and tolerability of SPD489 in treating core symptoms of ADHD in children and adolescents aged 6-17 and adults aged 18-55 years, the majority of the controlled studies have been of short duration (up to 8 weeks). A number of long-term studies have been undertaken and these have confirmed the safety and ongoing efficacy in this patient population.


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

Inclusion Criteria:

  • DSM IV criteria for ADHD
  • baseline ADHD-RS-IV .28
  • female of childbearing potential must have negative pregnancy test at baseline (Visit 0)
  • subjects parent or legally authorised representative must provide signature of IC
  • subject parent/LAR are willing and able to comply with all the testing and requirements, including oversight of morning dose at approximately 7.00Am
  • subject has blood pressure measurements within the 95th percentile for age, sex and height at screening visit (v-1) and Baseline (V0)
  • subject is functioning at an age-appropriate level intellectually
  • subject is able to swallow capsule

Exclusion Criteria:

  • subject has a current controlled or uncontrolled comorbid psychiatric diagnosis
  • subjects weight < 22,7 kg or is significantly underweight based on WHO BMI at screening visit
  • subject has a conduct disorder
  • subject has a concurrent chronic or acute illness
  • subject is currently considered a suicide risk
  • subject has glaucoma
  • subject is significantly overweight based on WHO BMI
  • subject has current abnormal thyroid function
  • subject has any clinically significant ECG at screening or baseline
  • subject has a documented allergy, hypersensitivity or intolerance to any active ingredient or excipients in SPD 489
  • subject has a recent history of suspected substance abuse or dependence disorder
  • subject has a history of seizures
  • subject has a known history of symptomatic cardiovascular or cerebrovascular disease
  • subject has a known family history of sudden cardiac death or ventricular arrhythmia
  • subject is taking any medication that is excluded
  • subject has a medical condition other than ADHD, that requires treatment with medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01413165

Contact: Evelyn heynen

Maastricht University Medical Centre Active, not recruiting
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Andries Korebrits, Prof., Dr. Psychiatrie
  More Information

No publications provided

Responsible Party: Shire Development Inc. Identifier: NCT01413165     History of Changes
Other Study ID Numbers: 101090
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 25, 2015