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Sponsors and Collaborators: |
University of Medicine and Dentistry New Jersey National Alliance for Autism Research |
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Information provided by: | University of Medicine and Dentistry New Jersey |
ClinicalTrials.gov Identifier: | NCT00252603 |
Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members.
The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize:
Condition | Intervention | Phase |
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Autism Childhood Autism |
Drug: Galantamine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Galantamine Versus Placebo in Childhood Autism |
Estimated Enrollment: | 20 |
Study Start Date: | April 2004 |
Estimated Study Completion Date: | April 2007 |
Once enrolled in the study, subjects will receive evaluations and testing to determine if they meet the necessary criteria for admission into study treatment. Subjects will not be responsible for the costs of any evaluations or tests conducted as part of this study.
First, subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child’s diagnosis and current problem areas. The subject’s parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.
Second, urine and blood samples will be needed for routine tests two times during this study (before any study related tests are done, and at the end of the study). Two teaspoons of blood will be drawn each time. The urine sample will be analyzed in order to assess kidney function and to screen for the presence of drugs (such as cocaine, marijuana, heroin, etc.). A positive drug screen would result in the inability of the child to participate in this study. Drug screen results will be kept confidential. In addition, an electrocardiogram will be performed to determine heartbeat.
Lastly, a pregnancy test will be conducted on the urine sample if the child is female and has reached puberty. The child should not be in this study if she is pregnant or a nursing mother. A positive urine pregnancy test would cause the child to be removed from the study. If the child is sexually active, she must be using an effective method of birth control during her participation in this study. Acceptable methods of birth control are oral contraceptive medications (the administration of which must be parentally supervised), IUD, depot medication and tubal ligation.
Subjects will be assigned by chance to receive either the active medication (Galantamine) or placebo (sugar pill) for 12 weeks, much like the flip of a coin. Neither the parent/child nor the investigator will know which of the two treatments the child is receiving. The child has a 50% chance of being assigned to receive placebo during the study or the active medication, Galantamine, during the study.
The child will need to be seen weekly by the study psychiatrist for the first 4 weeks of the twelve-week study, and every other week for the remaining weeks of the study. During these visits the study psychiatrist will ask the parent for feedback on his/her child’s condition and any changes that may be related to the medication, including possible side effects, such as nausea and headaches, and will check the child’s condition. The psychiatrist will also record his/her weight. These study visits will generally last approximately 30 minutes.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Exclusion Criteria:
Subjects with present or history of the following:
Subjects who have received any of the following interventions within the prescribed period before starting treatment:
Gender
United States, New Jersey | |
UMDNJ Robert Wood Johnson Medical School - Dept of Psychiatry | |
Piscataway, New Jersey, United States, 08854 |
Principal Investigator: | Sherie Novotny, MD | University of Medicine and Dentistry New Jersey |
Study ID Numbers: | 4682 |
Study First Received: | November 9, 2005 |
Last Updated: | January 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00252603 |
Health Authority: | United States: Food and Drug Administration |
Autism Childhood Autism |
Developmental Disabilities Child Development Disorders, Pervasive Galantamine |
Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
Parasympathomimetics Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents |
Pharmacologic Actions Cholinesterase Inhibitors Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |