A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety of methylphenidate HCL extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity Disorder (ADHD)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Investigator determined diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria with symptomatology from childhood to adulthood, symptoms present before age seven years and continue to meet full DSM-IV criteria at time of assessment

• Diagnosis confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) at Baseline and Adult ADHD Investigator Symptom Rating Scale (AISRS) score of 24 or greater as determined by the Investigator at Baseline

• Global Assessment of Functioning (GAF) Scale score of 41 to 60, inclusive, at Baseline

• Minimum weight of 100 lbs (45.4 kg) at Screening

• Negative urine drug test at the Screening and Baseline Visits when tested for drugs of abuse

Exclusion Criteria:

• Known to be non-responders to methylphenidate or other stimulants for the treatment of ADHD

• History of allergy, sensitivity or contraindication to methylphenidate or components of methylphenidate HCl extended-release tablets

• Coexisting medical condition or taking concomitant medication that would interfere with safe administration of methylphenidate in the Investigator's opinion

• Known structural cardiac abnormality

• Diagnosis of or family history of Tourette's syndrome, or motor or verbal tics

• History of seizures or a seizure disorder other than febrile seizures in childhood

• Glaucoma

• Uncontrolled hyperthyroidism or hypothyroidism