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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Florida

Center for Children and Families

Miami, Florida, United States, 33199

Sponsors and Collaborators

Noven Pharmaceuticals, Inc.

Investigators

• Principal Investigator: James Waxmonsky, MD; Not Affiliated

More Information

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

Keywords provided by Noven Pharmaceuticals, Inc.:

ADHD

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Amphetamine; Dextroamphetamine; 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