Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials

N

Noven Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Methylphenidate Transdermal System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151957
SPD485-303

Details and patient eligibility

About

This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Full description

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Enrollment

450 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.
  • Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion criteria

  • Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols
  • Female subject is pregnant or lactating

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

450 participants in 1 patient group

Methylphenidate transdermal system
Experimental group
Description:
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
Treatment:
Drug: Methylphenidate Transdermal System

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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