Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Shire

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride); Drug: Amphetamine + SPD503

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151996

SPD503-205

Details and patient eligibility

About

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

Enrollment: 75 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Methylphenidate + SPD503

Experimental group

Treatment:

Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)

Amphetamine + SPD503

Experimental group

Treatment:

Drug: Amphetamine + SPD503