Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Phase IV, Multi-center, Open-label Study of DAYTRANA (Methylphenidate Transdermal System [MTS]) to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434213
• Other study ID #: SPD485-411
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2007
• Last updated: June 23, 2015
• Start date: January 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2015
• Source: Noven Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: July 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Daytrana
Methylphenidate Transdermal System (MTS)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Noven Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Warshaw EM, Squires L, Li Y, Civil R, Paller AS. Methylphenidate transdermal system: a multisite, open-label study of dermal reactions in pediatric patients diagnosed with ADHD. Prim Care Companion J Clin Psychiatry. 2010;12(6). pii: PCC.10m00996. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	7 weeks	Yes
Secondary	Contact Sensitization to Methylphenidate	Contact sensitization to methylphenidate through skin patch testing.	7 weeks	Yes

External Links

•   (FDA Recall Information)
•   (FDA-approved Label)