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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
Sponsor:
Collaborator:
Shire
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01413165
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted

August 9, 2011
August 9, 2011
August 2011
August 2013   (final data collection date for primary outcome measure)
ADHD rating scale IV [ Time Frame: two years ] [ Designated as safety issue: No ]
to define subjects ADHD rating
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase 4, Open Label, Multicentre, 2 Year Safety Study of Lisdexamfetamine Dimesylate in Children/Adolescents With ADHD
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)

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

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Attention Deficit Disorder With Hyperactivity
Drug: Lisdexamfetamine dimesylate
daily morning dose (30,50 and 70mg)
Other Name: SPD 489
Experimental: Lisdexamfetamine
Intervention: Drug: Lisdexamfetamine dimesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
12
December 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 17 Years
No
Contact: Evelyn heynen e.heynen@mumc.nl
Netherlands
 
NCT01413165
101090
Yes
Shire Development Inc.
Maastricht University Medical Center
Shire
Principal Investigator: Andries Korebrits, Prof., Dr. Psychiatrie
Maastricht University Medical Center
August 2011

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