Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252603
Status:
COMPLETED
Last Update Posted:
2007-01-29
First Post:
2005-11-09
Brief Title:
Galantamine Versus Placebo in Childhood Autism
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Galantamine Versus Placebo in Childhood Autism
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Autism is a severe neurodevelopmental disorder that affects up to 16 in 10000 individuals It is a pervasive developmental disorder affecting social communicative and compulsiverepetitive 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 childhoodadolescent autism fulfilling DSM-IV and Autism Diagnostic Interview ADI criteria We therefore hypothesize
1 Galantamine will be superior to placebo in the acute treatment of global autism
2 Galantamine will be superior to placebo in improving functional ability
3 Galantamine will be superior to placebo in improving language function
4 Galantamine will be superior to placebo improving irritable and hyperactive behavior
5 Galantamine will be superior to placebo in improving social deficits
The proposed study is designed to assess the efficacy of treatment with Galantamine vs placebo in childhoodadolescent autism fulfilling DSM-IV and Autism Diagnostic Interview ADI criteria We therefore hypothesize
1 Galantamine will be superior to placebo in the acute treatment of global autism
2 Galantamine will be superior to placebo in improving functional ability
3 Galantamine will be superior to placebo in improving language function
4 Galantamine will be superior to placebo improving irritable and hyperactive behavior
5 Galantamine will be superior to placebo in improving social deficits
Detailed Description:
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 shehe 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 childs diagnosis and current problem areas The subjects 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 parentchild 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 hisher childs condition and any changes that may be related to the medication including possible side effects such as nausea and headaches and will check the childs condition The psychiatrist will also record hisher weight These study visits will generally last approximately 30 minutes
First subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if shehe 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 childs diagnosis and current problem areas The subjects 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 parentchild 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 hisher childs condition and any changes that may be related to the medication including possible side effects such as nausea and headaches and will check the childs condition The psychiatrist will also record hisher weight These study visits will generally last approximately 30 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None