Status:
COMPLETED
Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
Lead Sponsor:
Noven Therapeutics
Collaborating Sponsors:
Noven Pharmaceuticals, Inc.
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
Detailed Description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerabili...
Eligibility Criteria
Inclusion
- Subject must have a primary diagnosis of ADHD
- Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test
Exclusion
- A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually
- A recent history of suspected substance abuse or dependence disorder
- Subject is taking Strattera
- Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT00151983
Start Date
June 1 2005
End Date
July 1 2006
Last Update
July 9 2015
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Meadowbrook Research, Inc.
Scottsdale, Arizona, United States
2
Psychiatric Centers at San Diego
San Marcos, California, United States
3
Alpine Clinical Research Center
Boulder, Colorado, United States
4
Miami Research Associates, Inc.
Miami, Florida, United States