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

NCT01711021 | Completed Phase 2 Results FDA Drug

• 1 other identifier: N25-006
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

• Mean Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score During the Double-Blind Treatment Period

  The SKAMP total score comprises all 13 items. The SKAMP was designed for independent observers to rate 13 items representing 2 factors of classroom behavior: attention (SKAMP-A) and deportment (SKAMP-D), as well as quality of work. Items are specific to place (classroom setting) \& time (during a typical classroom period), \& the scale is used to assess multiple ratings taken within a day. The SKAMP-D subscale evaluates deportment, including interacting with other children, interacting with adults, remaining quiet according to classroom rules, \& staying seated according to classroom rules. The SKAMP-A subscale is a measure of attention \& evaluates getting started on assignments, sticking with tasks, attending to an activity, and making activity transitions. The SKAMP quality of work subscale includes 3 items: completing assigned work, performing work accurately, and being careful and neat while writing or drawing. Scores range from 0-78 with higher scores indicating worse impairment.

  Mean SKAMP Total Score of SKAMP Total Scores from 9 different time points including (1, 2, 3, 4.5, 6, 7, 9, 10, 12 hours post-dose)

Secondary Outcomes (6)

• Onset of Efficacy Measured by Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Total Score

  Onset of efficacy defined as the time of the first assessment time showing statistical significance between d-ATS and placebo. 2 hours post-dose in Double-Blind Treatment Period

• Duration of Effect for d-Amphetamine and Placebo Treatment

  Duration of Effect was from onset (2 hours post-dose) and up to 12 hours post-dose (p<0.001)

• Permanent Product Measure of Performance (PERMP) Scores Including PREMP-C and PREMP-A From Different Timepoints Post-dose

  1,2, 3, 4.5,6,7,9,10 and 12 hours post-dose from double-blind treatment period

• Change in the Clinician-rated Scale of ADHD Symptoms Based on DSM-IV-TR Criteria (ADHD-RS-IV).

  Averaged from week 6 and week 7 results during the Double-Blind Cross-Over treatment period.

• Conners Parent Rating Scale Revised Short Form (CPRS-R:S) Total Scores From Week 6 and Week 7

  Combined analysis by treatment groups from week 6 and week 7 (averaged)

Study Arms (2)

d-Amphetamine Transdermal patch

ACTIVE COMPARATOR

The study was conducted in 2 parts: a 5-week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. Subjects who reached the optimal dose by end of dose optimization treatment period were randomized to receive double-blind treatment. Participants first received study patches everyday for one week, then subjects were crossed-over to receive the placebo treatment. 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.

Drug: d-Amphetamine Transdermal Patch

Placebo patch

PLACEBO COMPARATOR

The study was conducted in 2 parts: a 5-week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. Subjects who reached the optimal dose by end of dose optimization treatment period were randomized to receive double-blind treatment. Participants first received placebo patches everyday for one week, then subjects were crossed-over to receive the study treatment. 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.

Drug: Placebo patch

Interventions

d-Amphetamine Transdermal Patch DRUG

The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. 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.

Also known as: d-Amphetamine, Amphetamine

d-Amphetamine Transdermal patch

Placebo patch DRUG

The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period. 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.

Also known as: Placebo, Sham treatment

Placebo patch

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gender: Male or female
• Age: Between 6 and 17 years of age (inclusive)
• Race: All eligible
• Females of child-bearing potential must have agreed to practice a clinically accepted method of contraception during the study and for at least 1 month prior to study dosing and 1 month following completion of the study. Acceptable contraceptive methods included abstinence, oral contraception, surgical sterilization (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, diaphragm in addition to spermicidal foam and condom on male partner, or systemic contraception (e.g., Norplant System)
• Must have met Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD combined, hyperactive/impulsive subtype, or predominately inattentive subtype
• The Screening and Baseline visit ADHD-RS-IV total score must have been ≥90% of the general population of children by age and gender
• Able to wear a patch for 9 hours (for children and, if applicable, for adolescents, parent or caregiver must be present to apply and remove the patches and maintain the used and unused patches in a secure, controlled area of the home)
• Functioning at an age-appropriate level intellectually as determined by an intelligence quotient (IQ) of ≥80 on the Wechsler Abbreviated Scale of Intelligence II™ (WASI II™) vocabulary and matrix reasoning components
• Must have been able to complete PERMP assessment
• Must have provided parental consent (signed ICF) and obtained written/verbal assent from the subject
• Subject and parent(s)/ caregiver must have been willing and able to comply with all the protocol requirements and parent(s) or caregiver must be able to provide transportation for the subject to and from the analog classroom sessions

You may not qualify if:

• Blood pressure outside the 95th percentile for age and gender
• Pulse of \<50 (age 6 - 17), or \>120 (age 6 - 12), or \>125 (age 13 - 17)
• Known non-responder to amphetamine treatment
• Documented allergy, intolerance, or hypersensitivity to amphetamine
• Currently taking an ADHD medication that is providing symptom control with no residual impairment at home or school and has acceptable tolerability and adherence
• Recent history (within the past 6 months) of suspected substance abuse or dependence disorder (including nicotine)
• Any psychiatric disorder that could interfere with study participation or the safety of the subject or other participants, such as conduct disorder (CD) or oppositional defiant disorder (ODD) 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
• Autism or Asperger's Disorder
• Family history (first degree relatives) of sudden cardiac death
• 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, was considered a suicide risk, had recent (last 6 months) suicidal ideation, or any lifetime self-harm event
• History of abnormal thyroid function
• Has a body mass index (BMI) for age greater than 95th percentile per Centers for Disease Control BMI (for gender-specific charts)
• Known history of symptomatic cardiovascular disease, advanced 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
• Any skin abnormality present at the potential application site (i.e., infection, rash, atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo)
• History of hypersensitivity, allergy to topical medication, preparation, or adhesive dressings

Sponsors & Collaborators

• Noven Pharmaceuticals, Inc.: lead

Study Sites (3)

University of California - Irvine

Irvine, California, 92612, United States

Location

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

Center for Psychiatry and Behavioral Medicine Inc.

Las Vegas, Nevada, 89128, United States

Location

Related Publications (2)

• Cutler AJ, Suzuki K, Starling B, Balakrishnan K, Komaroff M, Meeves S, Castelli M, Childress A. d-Amphetamine Transdermal System in Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Secondary Endpoint Results and Post Hoc Effect Size Analyses from a Pivotal Trial. J Child Adolesc Psychopharmacol. 2023 Jun;33(5):176-182. doi: 10.1089/cap.2023.0005.

  PMID: 37339441 DERIVED

• Cutler AJ, Suzuki K, Starling B, Balakrishnan K, Komaroff M, Castelli M, Meeves S, Childress AC. Efficacy and Safety of Dextroamphetamine Transdermal System for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: Results from a Pivotal Phase 2 Study. J Child Adolesc Psychopharmacol. 2022 Mar;32(2):89-97. doi: 10.1089/cap.2021.0107. Epub 2022 Jan 11.

  PMID: 35020462 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dextroamphetamine; Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Noven Pharmaceuticals, Inc.

ClinicalTrials@noven.com

(305) 253-5099

Study Officials

• James Waxmonsky, MD

  Not Affiliated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Locations

US (3)