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Evaluate the Efficacy &Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With ADHD

This study is ongoing, but not recruiting participants.

Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00499863
  Purpose

To assess the efficacy and safety of efficacy of MTS compared to placebo, as determined by the change in the clinician completed ADHD Rating Scale - Version 4th Edition (ADHD-RS-IV), in the symptomatic treatment of adolescents (aged 13-17 years) diagnosed with ADHD.


Condition Intervention Phase
ADHD
Drug: methylphenidate transdermal system (DAYTRANA)
Drug: Placebo
Phase III

ChemIDplus related topics:   Methylphenidate hydrochloride    Methylphenidate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase IIIb, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Dose Optimization Study, Designed to Evaluate the Efficacy and Safety of Methylphenidate Transdermal System (MTS) in Adolescents Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:
  • evaluate change in the ADHD Rating Scale (ADHD-RS-IV) from baseline to endpoint [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate safety & tolerability based on occurrence of treatment-emergent adverse events (TEAEs), laboratory tests, vital signs, physical examinations, ECGs & weight. [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
  • assess CPRS-R, CGI-I, PGA, YQOL-R [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
  • assess skin tolerability using application skin site evaluation [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
  • assess relationship between plasma exposure and the safety and efficacy measures of MTS [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
  • assess impact of MTS vs placebo on sleep using the Post Sleep Questionnaire (PSQ). [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   250
Study Start Date:   July 2007
Estimated Study Completion Date:   August 2008
Primary Completion Date:   May 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
dose optimization with MTS
Drug: methylphenidate transdermal system (DAYTRANA)
dose optimization of 4 doses of the MTS transdermal patch over the same duration of wear
2: Placebo Comparator
placebo
Drug: Placebo
Placebo patch

  Eligibility
Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Subject must meet DSM-IV-TR criteria for a primary diagnosis of ADHD based on a detailed psychiatric evaluation.
  2. Subject must have a total score of ≥26 on the ADHD-RS-IV at the Baseline Visit (Visit 2).
  3. Subject must have a minimum level of intellectual functioning, as determined by an IQ (based on Kaufman Brief Intelligence Test [KBIT]) score of 80 or above.
  4. Subject has blood pressure measurements within the 95th percentile for age, gender, and height at Screening and Baseline.
  5. Subject is a male or female aged 13 17 years.
  6. Females must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use acceptable contraceptives throughout the study period and for 30 days after the last dose of IP.

Exclusion Criteria:

  1. Subject has a current, controlled (requiring a restricted medication) or uncontrolled, with significant symptoms such as Post Traumatic Stress Disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder.
  2. Subjects who, in the opinion of the Investigator, are acutely at risk for suicidal or violent behavior towards him/herself or others, or a history of a suicide attempt requiring medical intervention.
  3. Subject is overweight.
  4. Subject has a history of seizures during the last 2 years, a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
  5. Subject has Conduct Disorder.
  6. Subject has a positive urine drug or alcohol result at Screening (with the exception of subject's current stimulant therapy, if any).
  7. Subject has a history of alcohol or other substance abuse or dependence.
  8. Subject has taken an investigational drug within 30 days prior to screening.
  9. Subject has any abnormal thyroid function.
  10. Subject has any clinically significant laboratory abnormalities.
  11. Subject has severe allergic rhinitis, disability, or other condition that might confound the results of safety assessments administered in the study or that might increase risk to the subject. Mild, stable asthma is not exclusionary.
  12. The female subject is pregnant or lactating.
  13. Subject has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions which would interfere with trial assessments or compromise subject safety (e.g. dermatitis, eczema or psoriasis).
  14. Subject has sensitive-skin syndrome (definition: subjects who often develop nonspecific skin irritancy reactions to bland materials) or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
  15. Subject has clinical signs and symptoms of skin irritation (i.e., pruritus, burning, erythema) or scars or tattoos.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00499863

Show 32 study locations  Show 32 Study Locations

Sponsors and Collaborators
Shire Pharmaceutical Development

Investigators
Principal Investigator:     Robert L Finding, MD     University Hospitals Case Medical Center    
  More Information


Responsible Party:   Shire ( Timothy Whitaker, M.D. )
Study ID Numbers:   SPD485-409
First Received:   July 10, 2007
Last Updated:   May 14, 2008
ClinicalTrials.gov Identifier:   NCT00499863
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Methylphenidate
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008




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