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Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System Compared to Placebo in Children & Adolescents With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01711021
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : November 5, 2015
Information provided by (Responsible Party):
Noven Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 15, 2012
First Posted Date  ICMJE October 22, 2012
Last Update Posted Date November 5, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2012)
Change from baseline in total SKAMP Scores [ Time Frame: Measured weekly during a two-week double-blind treatment period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01711021 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System Compared to Placebo in Children & Adolescents With ADHD
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System (d-ATS) Compared to Placebo in Children and Adolescents With ADHD
Brief Summary This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
Detailed Description The study will consist of a four-week screening period, a 3-day wash-out period (if applicable), a five-week open-label, step-wise dose optimization period and two-week double blind randomized crossover treatment period with weekly classroom assessments and a safety follow-up by telephone 7 - 10 days after last dose of study drug.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: d-Amphetamine Transdermal System
    Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
    Other Names:
    • d-Amphetamine
    • Amphetamine
  • Drug: Placebo patch
    Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
    Other Names:
    • Placebo
    • Sham treatment
Study Arms  ICMJE
  • Active Comparator: d-Amphetamine Transdermal System
    d-Amphetamine Transdermal System
    Intervention: Drug: d-Amphetamine Transdermal System
  • Placebo Comparator: Placebo patch
    Placebo patch
    Intervention: Drug: Placebo patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2013)
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2012)
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gender: Male or female;
  • Age: Between 6 &17 years of age, inclusive;
  • Race: All eligible;
  • Females of child-bearing potential must agree to practice a clinically accepted method of contraception during the study & for at least one month prior to study dosing & one month following completion of the study. Acceptable contraceptive methods include abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), intrauterine device, or diaphragm in addition to spermicidal foam & condom on male partner, or systemic contraception [e.g. Norplant System];
  • Must meet Diagnostic & Statistical Manual of Mental Disorders, 4th edition - Text Revision criteria for a primary diagnosis of ADHD combined, predominately hyperactive impulsive type, or predominately inattentive type;
  • The screening & baseline visit ADHD-RS-IV total score must be 90% or greater relative to the general population of children by age & gender;
  • Must be able to wear a patch for 9 hours. Parent or caregiver must be present to apply & remove the patches & maintain the used & unused patches in a secure controlled area of the home;
  • Must be functioning at an age appropriate level intellectually as determined by an intelligence quotient of ≥80 on the Wechsler Abbreviated Scale of Intelligence II™, vocabulary & matrix reasoning components;
  • Must have the ability to complete PERMP assessment;
  • Have parental consent & written or verbal assent from the subject;
  • Subject & parent(s)/caregiver are willing & able to comply with all the protocol requirements & parent(s) or caregiver must be able to provide transportation for the subject to & from the analog classroom sessions.

Exclusion Criteria:

  • Has blood pressure & pulse outside the 95th percentile for age & gender;
  • Is a known non-responder to amphetamine treatment;
  • Has a documented allergy, intolerance, or hypersensitivity to amphetamine;
  • Is currently taking an ADHD medication that is providing symptom control with no residual impairment at home or school & has acceptable tolerability & adherence;
  • Has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (including nicotine);
  • Has a history of seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder (exclusive of transient tic disorder), a current diagnosis and/or a family history of Tourette's Disorder. Mild medication-induced tics are not exclusionary;
  • Has any psychiatric disorder that could interfere with study participation or the safety of the subject or other participants, such as conduct disorder or oppositional defiant disorder with a history of prominent aggressive outbursts. Children meeting CD or ODD but without prominent aggression will be allowed to enroll at the discretion of the investigator;
  • Has Autism or Asperger's Disorder;
  • Has a family history (first degree relatives) of sudden cardiac death;
  • Has current controlled (requiring medication) or uncontrolled comorbid psychiatric conditions such as post traumatic stress disorder, psychosis, bipolar illness, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, considered a suicide risk, has previously attempted suicide, has prior history of or is currently demonstrating suicidal ideation;
  • Has a history of abnormal thyroid function;
  • Has BMI for age greater than 95th percentile per CDC BMI-for-gender specific charts;
  • Has a known history of symptomatic cardiovascular disease, advance arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug;
  • Has any skin abnormality present at the potential application site that is likely to be aggravated by the study drug (i.e., infection, rash, atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo);
  • Has a history of hypersensitivity, allergy to topical medication, preparation, or adhesive dressings;
  • Has concurrent chronic or significant acute illnesses (such as severe allergic rhinitis or an infectious process requiring antibiotics, unless expected to resolve or has resolved by Day 0) disability or any unstable medical condition that in the investigator's opinion would lead to difficulty complying with the protocol requirements;
  • Has used any investigational drug within 30 days of the screening visit;
  • Has a history of physical, sexual, or emotional abuse in the last year;
  • Has a medical history of Hepatitis A, B,C or HIV;
  • Has positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01711021
Other Study ID Numbers  ICMJE N25-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Noven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Noven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Waxmonsky, MD Not Affiliated
PRS Account Noven Pharmaceuticals, Inc.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP