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

This study has been completed.
Sponsor:
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:
NCT00326300
First received: May 12, 2006
Last updated: May 20, 2011
Last verified: April 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00326300     History of Changes
Other Study ID Numbers: CR011557
Study First Received: May 12, 2006
Last Updated: May 20, 2011
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

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014