A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

NCT00541346 | Completed Phase 3 Results DMC

• 1 other identifier: SPD485-420-Lock
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed. The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

Conditions

Autism; Attention Deficit Hyperactivity Disorder

Keywords

Autism; Autism Spectrum Disorders; ADHD

Outcome Measures

Primary Outcomes (1)

• Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit

  This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.

  Baseline, 8 weeks

Secondary Outcomes (10)

• Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit

  Baseline, 8 weeks

• Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit

  Baseline, 8 weeks

• Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit

  Baseline, 8 weeks

• Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit

  Baseline, 8 weeks

• Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit

  Baseline, 8 weeks

Study Arms (1)

Methylphenidate Transdermal System

EXPERIMENTAL

10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage

Drug: Methylphenidate Transdermal System

Interventions

Methylphenidate Transdermal System DRUG

10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage

Also known as: Daytrana, MethylPatch, MTS

Methylphenidate Transdermal System

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 6 and 11 years
• Autism Spectrum Disorder
• Attention Deficit Hyperactivity Disorder
• Stimulant medication-free at study entry
• No clinically significant abnormalities that preclude safe participation
• Sufficient developmental level (\~3 yrs)
• Able to keep appointments
• Able to communicate effectively
• Teacher cooperation

You may not qualify if:

• Received an investigational medication in the previous 30 days
• Current medication treatment is effective and well-tolerated
• Medical conditions that affect patient safety
• MAOIs within one month
• Hypertension
• Bipolar disorder or psychosis
• Anticonvulsants
• Psychotropic medication or health food supplement
• Tourette Disorder
• Seizure disorder
• Neurological condition
• Structural heart disease

Sponsors & Collaborators

• University of Oklahoma: lead
• Mark L. Wolraich, M.D.: collaborator

Study Sites (1)

OU Child Study Center

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (1)

• Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. doi: 10.1007/s11126-005-2980-7.

  PMID: 16080422 BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Thomas M. Lock, M.D.
• Organization: University of Oklahoma Health Sciences Center

Thomas-Lock@ouhsc.edu

405-271-5700

Study Officials

• Thomas M Lock, M.D.

  OU Child Study Center

  PRINCIPAL INVESTIGATOR

• Mark L Wolraich, M.D.

  OU Child Study Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2007
• First Posted: October 10, 2007
• Study Start: September 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: February 1, 2010
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2013-12

Locations

US (1)