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

NCT00326300 | Completed Phase 3

• 1 other identifier: CR011557
• Study Type: interventional
• Target: 560
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity Disorder, ADHD, Attention Deficit Disorder Adult

Outcome Measures

Primary Outcomes (1)

• Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination

Secondary Outcomes (1)

• Global Assessment of Effectiveness at titration visits, Months 3, 6, 9, 12 or Early Termination; Change from Baseline in the AISRS at titration visits, Months 3, 6, 9, 12 or Early Termination

Interventions

methylphenidate hydrochloride extended-release tablets DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.: lead

Related Publications (1)

• Adler LA, Orman C, Starr HL, Silber S, Palumbo J, Cooper K, Berwaerts J, Harrison DD. Long-term safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: an open-label, dose-titration, 1-year study. J Clin Psychopharmacol. 2011 Feb;31(1):108-14. doi: 10.1097/JCP.0b013e318203ea0a.

  PMID: 21192153 DERIVED

Related Links

• Open-Label, Dose-Titration, Long-Term Safety Study of CONCERTA (36 mg, 54 mg, 72 mg, 90 mg, 108 mg) in Adults With Attention Deficit Hyperactivity Disorder

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals Clinical Trial

  McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 12, 2006
• First Posted: May 16, 2006
• Study Start: April 1, 2006
• Study Completion: August 1, 2007
• Last Updated: May 24, 2011

Record last verified: 2010-04