Phase 3
Completed N=16
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Source: ClinicalTrials.gov NCT00541346 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Feb 2014
Primary outcomePrimary: Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit — 39.9; 13.8 units on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit |
39.9; 13.8 | <0.001 sig |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit |
34.1; 11.3 | <0.001 sig |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit |
19.8; 9.1 | <0.001 sig |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit |
11.3; 4.5 | <0.001 sig |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit |
5.6; 1.3 | <0.01 sig |
| SECONDARY Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit |
5.5; 2.1 | <0.001 sig |
| SECONDARY Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit |
26.6; 39.9 | <0.001 sig |
| SECONDARY Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit |
55.7; 53.5 | >0.21 |
| SECONDARY Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit |
28.8; 32.5 | >0.06 |
| SECONDARY Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit |
9.3; 14.9 | <0.01 sig |
| SECONDARY Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit |
32.6; 28.0 | >0.11 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00541346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.