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:
Maastricht University Medical Center
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
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Purpose
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.
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413165
Contacts
| Contact: Evelyn heynen | e.heynen@mumc.nl |
Locations
| Netherlands | |
| Maastricht University Medical Centre | Active, not recruiting |
| Maastricht, Netherlands | |
Sponsors and Collaborators
Maastricht University Medical Center
Shire Development LLC
Investigators
| Principal Investigator: | Andries Korebrits, Prof., Dr. | Psychiatrie |
More Information
No publications provided
| Responsible Party: | Shire Development Inc. |
| ClinicalTrials.gov 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 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 May 22, 2013