IRIS / MapLight: A research study of an investigational medication for adolescents and adults with Autism Spectrum Disorder
In the IRIS study, we are looking to find out whether the investigational “Study Drug”, designated ML-004, will help alleviate some of the symptoms that interfere with communication in those with autism spectrum disorder.
The Study Drug comes in the form of a tablet taken by mouth. The Study Drug is designed to release some medication immediately and to also release additional medication slowly throughout the day in order to maintain the correct levels of medication in the body. The Study Drug is investigational because it has not been approved for the treatment of ASD symptoms.
Dr. Danielle Baribeau - Clinician Scientist; Psychiatrist
Dr. Evdokia Anagnostou – Vice president of Research and Director of the Bloorview Research Institute; Child Neurologist; Canada Research Chair in Translational Therapeutics in Autism (Tier II)
Dr. Seyed Hassan Tonekaboni – MD; Research Fellow
Dr. Zahra Benn – MD; FRCPC
Lily He – Research Coordinator
Who can participate
To join this study, potential study participants must:
- Be 12 to 45 years of age
- Have a diagnosis of autism spectrum disorder (ASD)
- Have a care/study partner* willing to assist during the study
*The care/study partner is someone who lives with or has frequent contact with the study participant (parent, spouse, friends, etc.) and is willing and able to provide information about the participant and attend some study visits.
The study doctor’s staff will first give a detailed explanation of the IRIS study and its potential risks and benefits. This explanation will be made verbally and in writing. Only after obtaining written Informed Consent from the potential participant will any study-specific procedures take place. If the potential participant is a minor or incapable of fully understanding the decision to take part in the study, a legally authorized representative (such as a parent or guardian) must sign the Informed Consent form, and the potential participant will sign another form saying they agree to participate.
Next, the study doctor and the doctor’s staff will review medical records and conduct a series of study-related examinations and tests to see if the participant satisfies the requirements to enroll in this study. This process is called “screening.”
After screening, potential study participants who satisfy all requirements will begin the treatment period of the study. At some point during the treatment period, all participants will receive a placebo. (A placebo is a substance that looks like the Study Drug but has no active medication.) At other times during the treatment period, participants are assigned to take either the Study Drug or a placebo. This assignment is made randomly by a computer, and the chance of receiving either the Study Drug or placebo is 50/50, like flipping a coin. At no time will study participants be told whether or not they are taking placebo.
The treatment period will last approximately 16 weeks.
Approximately 30 days after the last dose of study medication, participants will receive a safety follow-up telephone call to check their overall health.
In total, participation in the IRIS study will take up to 26 weeks and includes up to 10 visits to the study clinic, plus the safety follow-up call.
What are the benefits of participating?
There may be potential risks to participating in this study. All drugs and medical procedures carry a risk of side effects; therefore, it is possible that participants may experience some discomfort or other reactions from use of the Study Drug. If you decide that partici¬pation may be right for you or a loved one, the study staff will explain the potential risks to you before any study procedures are conducted.
Interested in participating
If you or your loved one would like to take the next step toward possible participation or if you have more questions, please contact Lily He at email@example.com or 416-425-6220 ext. 6321.
REB #: 3930; A randomized, double-blind, parallel group, placebo-controlled study to investigate the efficacy, safety, and tolerability of ML-004 in adolescents and adults with autism spectrum disorders (ASD)