Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
NCT ID: NCT01711021
Last Updated: 2023-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2012-10-31
2013-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
d-Amphetamine Transdermal patch
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.
d-Amphetamine Transdermal Patch
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.
Placebo patch
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.
Placebo patch
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
d-Amphetamine Transdermal Patch
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.
Placebo patch
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age: Between 6 and 17 years of age (inclusive)
3. Race: All eligible
4. 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)
5. 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
6. The Screening and Baseline visit ADHD-RS-IV total score must have been ≥90% of the general population of children by age and gender
7. 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)
8. 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
9. Must have been able to complete PERMP assessment
10. Must have provided parental consent (signed ICF) and obtained written/verbal assent from the subject
11. 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
Exclusion Criteria
2. Pulse of \<50 (age 6 - 17), or \>120 (age 6 - 12), or \>125 (age 13 - 17)
3. Known non-responder to amphetamine treatment
4. Documented allergy, intolerance, or hypersensitivity to amphetamine
5. Currently taking an ADHD medication that is providing symptom control with no residual impairment at home or school and has acceptable tolerability and adherence
6. Recent history (within the past 6 months) of suspected substance abuse or dependence disorder (including nicotine)
7. History of seizures during the last 2 years (excluding 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 were not exclusionary
8. 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
9. Autism or Asperger's Disorder
10. Family history (first degree relatives) of sudden cardiac death
11. 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
12. History of abnormal thyroid function
13. Has a body mass index (BMI) for age greater than 95th percentile per Centers for Disease Control BMI (for gender-specific charts)
14. 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
15. Any skin abnormality present at the potential application site (i.e., infection, rash, atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo)
16. History of hypersensitivity, allergy to topical medication, preparation, or adhesive dressings
17. 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
18. Used any investigational drug within 30 days of the Screening visit
19. History of physical, sexual, or emotional abuse in the last year
20. Medical history of hepatitis A/B/C or HIV
21. Positive urine drug screen for drugs of abuse
6 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Noven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Waxmonsky, MD
Role: PRINCIPAL_INVESTIGATOR
Not Affiliated
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California - Irvine
Irvine, California, United States
Florida International University Center for Children and Families
Miami, Florida, United States
Center for Psychiatry and Behavioral Medicine Inc.
Las Vegas, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
N25-006
Identifier Type: -
Identifier Source: org_study_id