Safety & Tolerability of MTS in Children Aged 6-12 Diagnosed With ADHD & Previously Treated With Extended-Release Methylphenidate Therapy
Completed · Phase 3 · Has a placebo group
Conditions studied: Attention Deficit Disorder With Hyperactivity
In brief
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.
Key facts
- Study ID
- NCT00151983
- Run by
- Noven Therapeutics
- People needed
- 175
- Starts
- 2005-06-01
- Expected to finish
- 2006-07-01
- Last updated by the study team
- 2015-07-09
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Meadowbrook Research, Inc. — Scottsdale, Arizona, United States
- Psychiatric Centers at San Diego — San Marcos, California, United States
- Alpine Clinical Research Center — Boulder, Colorado, United States
- Miami Research Associates, Inc. — Miami, Florida, United States
- Capstone Clinical Research — Libertyville, Illinois, United States
- Pedia Research, LLC — Owensboro, Kentucky, United States
- ProMed Pediatrics — Kalamazoo, Michigan, United States
- Children's Specialized Hospital — Toms River, New Jersey, United States
- North Carolina Neuropsychiatry PA — Chapel Hill, North Carolina, United States
- Ohio State University — Columbus, Ohio, United States
- IPS Research Company — Oklahoma City, Oklahoma, United States
- Oregon Center for Clinical Investigations (OCCI, Inc.) — Portland, Oregon, United States
- CNS Research Institute — Philadelphia, Pennsylvania, United States
- Western Psychiatric Institute & Clinic — Pittsburgh, Pennsylvania, United States
- Claghorn-Lesem Research Clinic — Bellaire, Texas, United States
- ADHD Clinic of San Antonio — San Antonio, Texas, United States
- NeuroScience, Inc. — Herndon, Virginia, United States
- Monarch Medical Research — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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