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ConnectMe to a clinical research program in autism.
If your child is 6 to 12 years old, he or she may be eligible to participate in the ConnectMe clinical research program. The program includes three clinical research studies that will evaluate the safety, tolerability, and effectiveness of an investigational drug on social interaction and communication skills in children with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
The ConnectMe-91 study is currently enrolling patients. ConnectMe-68 and ConnectMe-69 are follow-up studies. If your child is eligible for and participates in ConnectMe-91, he or she may have the option to join the follow-up studies.
What is the purpose of the ConnectMe-91 study?
The purpose of this study is to evaluate the safety and tolerability of the investigational drug in children with autism, Asperger’s Disorder, or PDD-NOS and to identify participants who may be eligible to join the follow-up studies.
Who can participate in the study?
Your child may be eligible to participate if he or she:
- Is 6 to 12 years old
- Meets the diagnostic criteria for autism, Asperger’s Disorder, or PDD-NOS
- Is verbally fluent or uses some phrase speech
- Was not born 5 or more weeks premature or with a birth weight of less than 5 pounds
- Does not have a major psychiatric disorder (e.g., schizophrenia, major depressive disorder)
- Does not have a history of a seizure disorder
Study doctors will discuss all of the eligibility requirements with potential participants and their parents and caregivers as part of the screening process.
How long will the study last?
The study may last up to 50 weeks and require up to 13 visits to the study site. .
What will happen during the study?
The study will include a:
- 2-week screening period to determine if your child is eligible for the study
- 6-week period when your child will take a daily dose of the investigational drug that is based on his or her weight
- 42-week (about 10 months) period when your child will take a daily dose of the investigational drug that the study doctor determines works best for him or her
All participants will undergo common tests and procedures during the study, including blood and urine tests and physical exams. The study team will also use several standard surveys or questionnaires to evaluate your child’s condition. All study drug and study-related evaluations will be provided at no cost.
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