Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks.
Detailed description
This is a study designed to characterize the dermal response of DAYTRANA. Subjects will visit the study site over a period of approximately 14 weeks. Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy. Dermal response will be evaluated at each visit by the investigator. Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations (not to exceed a two week period) will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing.
Interventions
DRUGDaytrana
Methylphenidate Transdermal System (MTS)
Sponsors
Noven Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Must sign informed consent. * Male or female 6-12 years old. * Negative pregnancy test. * Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD. * No co-morbid illness that could affect safety, tolerability or interfere with participation. * Blood pressure (BP) within the 95th percentile for age, gender, and height. * Willing and able to comply with all the requirements defined in protocol.
Exclusion criteria
* Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]). * At risk for suicidal or violent behavior towards self or others. * History of a suicide attempt. * History of a structural cardiac abnormality or other serious cardiac problems. * Non-responder to psychostimulant treatment. * Is overweight. * Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder. * Has Conduct Disorder. * Known history of alcohol or other substance abuse within the last 6 months. * Any abnormal thyroid function. * A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments. * Has had treatment with any known liver altering agents within 30 days prior to Screening. * Taking any excluded medication. * Previous use of DAYTRANA. * Taking other medications that have Central Nervous System (CNS) effects. * Female subject is pregnant or lactating. * Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions. * Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives. * Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites. * A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dermal Reactions | 7 weeks | Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contact Sensitization to Methylphenidate | 7 weeks | Contact sensitization to methylphenidate through skin patch testing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daytrana Methylphenidate Transdermal System (MTS) | 309 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 12 |
| Overall Study | Application site reaction | 1 |
| Overall Study | Lack of Efficacy | 9 |
| Overall Study | Lost to Follow-up | 14 |
| Overall Study | Non-compliant to study schedule | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Unable to comply with study visit window | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Daytrana |
|---|---|
| Age, Categorical <=18 years | 309 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.1 years STANDARD_DEVIATION 1.95 |
| Region of Enrollment United States | 309 participants |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 242 / 305 |
| serious Total, serious adverse events | 0 / 305 |
Outcome results
Primary
Dermal Reactions
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Time frame: 7 weeks
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daytrana | Dermal Reactions | No dermal evaluation | 2 Participants |
| Daytrana | Dermal Reactions | 0 (no evidence of irritation) | 46 Participants |
| Daytrana | Dermal Reactions | 1 (minimal erythema) | 97 Participants |
| Daytrana | Dermal Reactions | 2 (definite eythema) | 151 Participants |
| Daytrana | Dermal Reactions | 3 (erythema and papules) | 6 Participants |
| Daytrana | Dermal Reactions | 4 (definite edema) | 3 Participants |
| Daytrana | Dermal Reactions | 5 (erythema, edema, and papules) | 0 Participants |
| Daytrana | Dermal Reactions | 6 (vesicular eruption) | 0 Participants |
| Daytrana | Dermal Reactions | 7 (strong reaction beyond test site) | 0 Participants |
Secondary
Contact Sensitization to Methylphenidate
Contact sensitization to methylphenidate through skin patch testing.
Time frame: 7 weeks
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daytrana | Contact Sensitization to Methylphenidate | 1 Participants |