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

This study is not yet open for participant recruitment.

Verified August 2011 by Maastricht University Medical Center

Sponsor:

Collaborator:

Shire Development LLC

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

Tracking Information

First Received Date ^ICMJE

August 9, 2011

Last Updated Date

August 9, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ADHD rating scale IV [ Time Frame: two years ] [ Designated as safety issue: No ]

to define subjects ADHD rating

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 4, Open Label, Multicentre, 2 Year Safety Study of Lisdexamfetamine Dimesylate in Children/Adolescents With ADHD

Official Title ^ICMJE

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)

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Attention Deficit Disorder With Hyperactivity

Intervention ^ICMJE

Drug: Lisdexamfetamine dimesylate

daily morning dose (30,50 and 70mg)

Other Name: SPD 489

Study Arm (s)

Experimental: Lisdexamfetamine

Intervention: Drug: Lisdexamfetamine dimesylate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Evelyn heynen

e.heynen@mumc.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01413165

Other Study ID Numbers ^ICMJE

101090

Has Data Monitoring Committee

Yes

Responsible Party

Shire Development Inc.

Study Sponsor ^ICMJE

Maastricht University Medical Center

Collaborators ^ICMJE

Shire Development LLC

Investigators ^ICMJE

Principal Investigator:

Andries Korebrits, Prof., Dr.

Psychiatrie

Information Provided By

Maastricht University Medical Center

Verification Date

August 2011

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

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