Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00151996
First received: September 7, 2005
Last updated: November 25, 2009
Last verified: November 2009
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Purpose
The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Disorder With Hyperactivity |
Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride) Drug: Amphetamine + SPD503 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open-Label Co-Administration Study of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD) |
Resource links provided by NLM:
Drug Information available for:
Methamphetamine hydrochloride
Methylphenidate
Methylphenidate hydrochloride
Amphetamine
Methamphetamine
Guanfacine
Guanfacine hydrochloride
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Total Score at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
- Number of Participants With Improvement on Parent Global Assessment (PGA) Scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Scores at 6 Weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | August 2004 |
| Study Completion Date: | May 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Methylphenidate + SPD503 | Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride) |
| Experimental: Amphetamine + SPD503 | Drug: Amphetamine + SPD503 |
Eligibility| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with a primary diagnosis of ADHD
- Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
- Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
Exclusion Criteria:
- Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
- History of seizure during the last 2 years
- Subject has any specific cardiac condition or family history of significant cardiac condition
- Subject is pregnant or lactating
Contacts and Locations
No Contacts or Locations Provided
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00151996 History of Changes |
| Other Study ID Numbers: | SPD503-205 |
| Study First Received: | September 7, 2005 |
| Results First Received: | September 10, 2009 |
| Last Updated: | November 25, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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 Amphetamine Methamphetamine Methylphenidate Central Nervous System Stimulants Guanfacine Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Antihypertensive Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on October 16, 2012
