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

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ClinicalTrials.gov Identifier: NCT01711021
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : November 5, 2015
Sponsor:
Information provided by (Responsible Party):
Noven Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: d-Amphetamine Transdermal System Drug: Placebo patch Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013


Arm Intervention/treatment
Active Comparator: d-Amphetamine Transdermal System
d-Amphetamine Transdermal System
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

Placebo Comparator: Placebo patch
Placebo patch
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




Primary Outcome Measures :
  1. Change from baseline in total SKAMP Scores [ Time Frame: Measured weekly during a two-week double-blind treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711021


Locations
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United States, Florida
Center for Children and Families
Miami, Florida, United States, 33199
Sponsors and Collaborators
Noven Pharmaceuticals, Inc.
Investigators
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Principal Investigator: James Waxmonsky, MD Not Affiliated

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Responsible Party: Noven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01711021     History of Changes
Other Study ID Numbers: N25-006
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: November 5, 2015
Last Verified: October 2015

Keywords provided by Noven Pharmaceuticals, Inc.:
ADHD

Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors