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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00499863
First received: July 10, 2007
Last updated: August 9, 2010
Last verified: August 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at Endpoint [ Time Frame: baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: No ]
    The Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.


Secondary Outcome Measures:
  • Change From Baseline in the Conner's Parent Rating Scale-Revised (CPRS-R) Total Score at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: No ]
    The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true).

  • Improvement in Clinical Global Impressions-Improvement (CGI-I) Score [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Improvement in Parent Global Assessment (PGA) Score [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]
    Parent Global Assessment (PGA) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.

  • Change From Baseline in Youth Quality of Life-research Version (YQOL-R) Total Score at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: No ]
    The Youth Quality of Life Instrument-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often).

  • Dermal Response Scale (DRS) Scores [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
    Mean dermal reaction scores were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.

  • Change From Baseline in Electrocardiogram Results(QTcF Interval) at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: Yes ]
    QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.

  • Change From Baseline in Pulse Rate at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Systolic Blood Pressure at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Weight at Endpoint [ Time Frame: Baseline and endpoint (up to 7 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 217
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Other Name: DAYTRANA
Placebo Comparator: 2
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 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
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: NCT00499863

  Show 32 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Robert L Finding, MD University Hospital Case Medical Center
  More Information

Additional Information:
Publications:
Findling et al. A Randomized, Double-Blind, Multicenter, Parallel-Group, Placebo-Controlled, Dose-Optimization Study of the Methylphenidate Transdermal System for the Treatment of ADHD in Adolescents. CNS Spectrums 2010; 15:419-430

Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00499863     History of Changes
Other Study ID Numbers: SPD485-409
Study First Received: July 10, 2007
Results First Received: April 24, 2009
Last Updated: August 9, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
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 22, 2014