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

Sponsored by:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:	NCT00326300

Purpose

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)

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: methylphenidate hydrochloride extended-release tablets	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label, Dose-Titration, Long-Term Safety Study to Evaluate CONCERTA (Methylphenidate HCL) Extended-Release Tablets at Doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg Per Day in Adults With Attention Deficit Hyperactivity Disorder

Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	560
Study Start Date:	April 2006
Study Completion Date:	August 2007

Detailed Description:

This is a multicenter, open-label, dose-titration, long-term study to evaluate the long-term safety of five dose levels of methylphenidate HCL extended-release tablets, 36 mg, 54 mg, 72 mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), and 108 mg (two 54 mg tablets) per day in adults with ADHD. At the baseline visit, all patients will initiate treatment with 36 mg of methylphenidate HCL extended-release tablets. The dose will be increased in 18 mg increments every seven days (+/-2 days) until an individualized dose is achieved. An individualized dose is achieved when there is at least a 30% improvement on the ADHD Investigator Symptoms Rating Scale (AISRS) and a Clinical Global Impression - Improvement (CGI-I) score of 1 or 2, or until the maximum dose of 108 mg is achieved. If a limiting adverse event occurs, the dose will be titrated downward by 18 mg. This dose is then the individualized dose. Once an individualized dose is achieved, patients will remain on that dose for approximately six months or one year, as assigned at the time of enrollment. Patients will be given a prescription for a one-month supply of drug and a pharmacy card at each visit. Safety assessments include monitoring adverse events, blood pressure, pulse, weight, and electrocardiograms (ECG) throughout the study. The study hypothesis is that methylphenidate HCL extended-release tablets in doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108 mg per day will have an acceptable safety profile for the management of ADHD in adults.

Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per day. The dose will be increased in 18 mg increments every 7 days (+/-2 days) until they achieve their individualized dose or reach a maximum dose of 108 mg daily. Following the patient's titration, the patient will remain on the individualized dose for approximately 6 months or one year as determined at the time of enrollment.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326300

Sponsors and Collaborators

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

Investigators

Study Director:

McNeil Consumer & Specialty Pharmaceuticals Clinical Trial

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

More Information

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 This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR011557
Study First Received:	May 12, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00326300
Health Authority:	United States: Food and Drug Administration

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Attention Deficit Hyperactivity Disorder, ADHD, Attention Deficit Disorder Adult

Study placed in the following topic categories:

Signs and Symptoms
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Methylphenidate
Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs

Central Nervous System Stimulants
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009