Overview

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