Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder
Condition: Pervasive Development Disorders
MeSH terms: Hyperkinesis; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself
      or in combination with methylphenidate (also known as Ritalin) is helpful for treating
      hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
    

Detailed description: 
      Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic
      Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise
      Specified. Children with PDD show delays in speech and language and reduced social
      interaction. Some children with PDD have also have problems with overactivity, impulsiveness
      and distractability. These behaviors are seen in children with Attention Deficit
      Hyperactivity Disorder (ADHD). Extended release guanfacine (Intuniv) is FDA-approved for the
      treatment of children with ADHD. The purpose of this study is to evaluate whether Intuniv is
      an effective treatment for ADHD symptoms in children with PDD.

      This study has four parts: an 8-week double-blind trial, an 8-week blinded extension phase
      (for positive responders only), an 8-week open-label trial, and a 4-week add-on study.
      Following confirmation of eligibility, participants will be randomly assigned to receive
      either guanfacine or placebo in the 8-week double-blind trial. Children who show improvement
      after 8 weeks of treatment will continue on their assigned treatment for an additional 8
      weeks (blinded extension phase). Children who show partial improvement with guanfacine will
      be offered 4 weeks of treatment with guanfacine plus methylphenidate (add-on study). Children
      who show no improvement on placebo will be offered 8 weeks of treatment with guanfacine
      (open-label trial). Children who show no improvement on guanfacine will exit the study.

      Side effects and treatment response will be assessed at regularly scheduled visits.

      The study protocol was formally revised with the Yale University IRB in May 2013 to address
      an early close to enrollment due to a reduction in funding. The original anticipated
      enrollment numbers of 112 subjects was reduced to 60 subjects. The study statistician was
      consulted prior to enrollment closure to address any issues related to statistical power and
      the adjustments made to the final statiscal analysis plan.
    

Intervention name(s): placebo; extended-release guanfacine
Intervention type(s): Other; Drug
Intervention description(s): Administered for up to 8 weeks.; 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pervasive Developmental Disorders; PDD; PDD-NOS; Autistic Disorder; Autism; Asperger's Disorder; Hyperactivity; Attention Deficit Hyperactivity Disorder; ADHD; Medication; Drug; Guanfacine; Intuniv; Placebo; Methylphenidate