AutismPhase 3NCT00252603
Galantamine Versus Placebo in Childhood Autism
A Phase 3 study testing Galantamine in people with Autism and Childhood Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism, Childhood Autism
- What is being tested?
- Galantamine
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.
- Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
- Subjects with active seizure disorder (seizures within the past six months).
- Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.
- Subjects with present or history of the following:
- gastrointestinal, liver, kidney, or other known conditions which will presently interfere with the absorption, distribution, metabolism, or excretion of drugs,
Show all 25Show fewer
- seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior,
- clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism or diabetes,
- recent history or presence of any form of malignancy.
- Subjects who report significant improvement of autism symptoms and behaviors to current medications or have only global autism ratings on the CGI of absent, minimal or mild severity, or who are more than minimally verbal.
- Subjects whose global autism ratings are assessed as being absent, minimal or mild.
- Treatment within the previous 30 days with any drug known to have a well-defined potential for toxicity to a major organ.
- Subjects with clinically significant abnormalities in laboratory tests or physical exam.
- Subjects likely to require any other psychotropic medication during the study, with the exception of clonidine for insomnia (started at least one month prior to entrance into the study), as well as anticonvulsants at a constant dose for stable seizure disorder or, unless otherwise permitted.
- Subjects unable to tolerate taper from psychoactive medication, if specified.
- Subjects with a history of hypersensitivity or severe side effects associated with the use of galantamine, or other acetylcholinesterase inhibitors.
- Subjects with a history of prior treatment with galantamine of 4mg/day for 6 weeks.
- Subjects who have received any of the following interventions within the prescribed period before starting treatment:
- investigational drugs within the previous 30 days.
- monoamine oxidase inhibitors within the previous fourteen days.
- long-acting phenothiazines within the previous six weeks.
- other psychotropic drugs within the previous seven days, unless otherwise permitted.
- Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.
- Subjects who reside in a remote geographical area or who do not have regular access to transportation to the clinical facility.
- Gender
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ Robert Wood Johnson Medical School - Dept of Psychiatry
Piscataway, New Jersey, 08854
About this study
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:
- Galantamine will be superior to placebo in the acute treatment of global autism.
- Galantamine will be superior to placebo in improving functional ability.
- Galantamine will be superior to placebo in improving language function.
- Galantamine will be superior to placebo improving irritable and hyperactive behavior.
- Galantamine will be superior to placebo in improving social deficits.
Read the 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 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.
- Conditions
- Autism, Childhood Autism
- Being tested
- Galantamine
- Keywords
- Autism, Childhood Autism
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalantamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit
Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit
Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit
Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit
MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit
Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startApr 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Autism Research
- Investigators
- Sherie Novotny, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252603
- Sponsor's protocol ID
- 4682
- Status last verified
- Jan 2007
- First submitted
- 9 Nov 2005
- Last updated
- 29 Jan 2007
- Results posted
- No
Publications
Allin M, Matsumoto H, Santhouse AM, Nosarti C, AlAsady MH, Stewart AL, Rifkin L, Murray RM. Cognitive and motor function and the size of the cerebellum in adolescents born very pre-term. Brain. 2001 Jan;124(Pt 1):60-6. doi: 10.1093/brain/124.1.60.
PubMed 11133787Aman MG, Van Bourgondien ME, Wolford PL, Sarphare G. Psychotropic and anticonvulsant drugs in subjects with autism: prevalence and patterns of use. J Am Acad Child Adolesc Psychiatry. 1995 Dec;34(12):1672-81. doi: 10.1097/00004583-199512000-00018.
PubMed 8543539Aman MG, Singh NN, Stewart AW, Field CJ. Psychometric characteristics of the aberrant behavior checklist. Am J Ment Defic. 1985 Mar;89(5):492-502.
PubMed 3158201Anderson LT, Campbell M, Grega DM, Perry R, Small AM, Green WH. Haloperidol in the treatment of infantile autism: effects on learning and behavioral symptoms. Am J Psychiatry. 1984 Oct;141(10):1195-202. doi: 10.1176/ajp.141.10.1195.
PubMed 6385731Birmaher B, Quintana H, Greenhill LL. Methylphenidate treatment of hyperactive autistic children. J Am Acad Child Adolesc Psychiatry. 1988 Mar;27(2):248-51. doi: 10.1097/00004583-198803000-00020. No abstract available.
PubMed 3360732Chakrabarti S, Fombonne E. Pervasive developmental disorders in preschool children. JAMA. 2001 Jun 27;285(24):3093-9. doi: 10.1001/jama.285.24.3093.
PubMed 11427137Ghaziuddin M, Tsai L, Ghaziuddin N. Fluoxetine in autism with depression. J Am Acad Child Adolesc Psychiatry. 1991 May;30(3):508-9. doi: 10.1097/00004583-199105000-00029. No abstract available.
PubMed 2055895Greenspan, S.I. & Wieder, S. Developmental patterns and outcomes in infants and children with disorders in relating and communicating A chart review of 200 cases of children with autistic spectrum diagnoses. J Dev Learning Disord, 1997;1:87-141.
Kern JK, Miller VS, Cauller PL, Kendall PR, Mehta PJ, Dodd M. Effectiveness of N,N-dimethylglycine in autism and pervasive developmental disorder. J Child Neurol. 2001 Mar;16(3):169-73. doi: 10.1177/088307380101600303.
PubMed 11305684Martin A, Scahill L, Klin A, Volkmar FR. Higher-functioning pervasive developmental disorders: rates and patterns of psychotropic drug use. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):923-31. doi: 10.1097/00004583-199907000-00024.
PubMed 10405512Perry EK, Lee ML, Martin-Ruiz CM, Court JA, Volsen SG, Merrit J, Folly E, Iversen PE, Bauman ML, Perry RH, Wenk GL. Cholinergic activity in autism: abnormalities in the cerebral cortex and basal forebrain. Am J Psychiatry. 2001 Jul;158(7):1058-66. doi: 10.1176/appi.ajp.158.7.1058.
PubMed 11431227Ritvo ER, Mason-Brothers A, Freeman BJ, Pingree C, Jenson WR, McMahon WM, Petersen PB, Jorde LB, Mo A, Ritvo A. The UCLA-University of Utah epidemiologic survey of autism: the etiologic role of rare diseases. Am J Psychiatry. 1990 Dec;147(12):1614-21. doi: 10.1176/ajp.147.12.1614.
PubMed 2244638Rutter M. The development of infantile autism. Psychol Med. 1974 May;4(2):147-63. doi: 10.1017/s0033291700041982. No abstract available.
PubMed 4597904Steffenburg S. Neuropsychiatric assessment of children with autism: a population-based study. Dev Med Child Neurol. 1991 Jun;33(6):495-511. doi: 10.1111/j.1469-8749.1991.tb14915.x.
PubMed 1864476Thal DJ, O'Hanlon L, Clemmons M, Fralin L. Validity of a parent report measure of vocabulary and syntax for preschool children with language impairment. J Speech Lang Hear Res. 1999 Apr;42(2):482-96. doi: 10.1044/jslhr.4202.482.
PubMed 10229462
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galantamine Versus Placebo in Childhood Autism
- ClinicalTrials.gov ID
- NCT00252603
- Acronym / sponsor ID
- 4682
- Conditions
- Autism, Childhood Autism
- Keywords
- Autism, Childhood Autism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Alliance for Autism Research
- Study start
- Apr 2004
- Study completion
- Apr 2007
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Galantamine will be superior to placebo in the acute treatment of global autism.
- Galantamine will be superior to placebo in improving functional ability.
- Galantamine will be superior to placebo in improving language function.
- Galantamine will be superior to placebo improving irritable and hyperactive behavior.
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (25 listed)
- Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.
- Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
- Subjects with active seizure disorder (seizures within the past six months).
- Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.
- Subjects with present or history of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galantamine | Drug | – |
Primary outcome
Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit
Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit
Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit
Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit
MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit
Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2007.
- Background: PubMed 11133787Allin M, Matsumoto H, Santhouse AM, Nosarti C, AlAsady MH, Stewart AL, Rifkin L, Murray RM. Cognitive and motor function and the size of the cerebellum in adolescents born very pre-term. Brain. 2001 Jan;124(Pt 1):60-6. doi: 10.1093/brain/124.1.60.
- Background: PubMed 8543539Aman MG, Van Bourgondien ME, Wolford PL, Sarphare G. Psychotropic and anticonvulsant drugs in subjects with autism: prevalence and patterns of use. J Am Acad Child Adolesc Psychiatry. 1995 Dec;34(12):1672-81. doi: 10.1097/00004583-199512000-00018.
- Background: PubMed 3158201Aman MG, Singh NN, Stewart AW, Field CJ. Psychometric characteristics of the aberrant behavior checklist. Am J Ment Defic. 1985 Mar;89(5):492-502.
- Background: PubMed 6385731Anderson LT, Campbell M, Grega DM, Perry R, Small AM, Green WH. Haloperidol in the treatment of infantile autism: effects on learning and behavioral symptoms. Am J Psychiatry. 1984 Oct;141(10):1195-202. doi: 10.1176/ajp.141.10.1195.
- Background: PubMed 3360732Birmaher B, Quintana H, Greenhill LL. Methylphenidate treatment of hyperactive autistic children. J Am Acad Child Adolesc Psychiatry. 1988 Mar;27(2):248-51. doi: 10.1097/00004583-198803000-00020. No abstract available.
- Background: PubMed 11427137Chakrabarti S, Fombonne E. Pervasive developmental disorders in preschool children. JAMA. 2001 Jun 27;285(24):3093-9. doi: 10.1001/jama.285.24.3093.
- Background: PubMed 2055895Ghaziuddin M, Tsai L, Ghaziuddin N. Fluoxetine in autism with depression. J Am Acad Child Adolesc Psychiatry. 1991 May;30(3):508-9. doi: 10.1097/00004583-199105000-00029. No abstract available.
- BackgroundGreenspan, S.I. & Wieder, S. Developmental patterns and outcomes in infants and children with disorders in relating and communicating A chart review of 200 cases of children with autistic spectrum diagnoses. J Dev Learning Disord, 1997;1:87-141.
- Background: PubMed 11305684Kern JK, Miller VS, Cauller PL, Kendall PR, Mehta PJ, Dodd M. Effectiveness of N,N-dimethylglycine in autism and pervasive developmental disorder. J Child Neurol. 2001 Mar;16(3):169-73. doi: 10.1177/088307380101600303.
- Background: PubMed 10405512Martin A, Scahill L, Klin A, Volkmar FR. Higher-functioning pervasive developmental disorders: rates and patterns of psychotropic drug use. J Am Acad Child Adolesc Psychiatry. 1999 Jul;38(7):923-31. doi: 10.1097/00004583-199907000-00024.
- Background: PubMed 11431227Perry EK, Lee ML, Martin-Ruiz CM, Court JA, Volsen SG, Merrit J, Folly E, Iversen PE, Bauman ML, Perry RH, Wenk GL. Cholinergic activity in autism: abnormalities in the cerebral cortex and basal forebrain. Am J Psychiatry. 2001 Jul;158(7):1058-66. doi: 10.1176/appi.ajp.158.7.1058.
- Background: PubMed 2244638Ritvo ER, Mason-Brothers A, Freeman BJ, Pingree C, Jenson WR, McMahon WM, Petersen PB, Jorde LB, Mo A, Ritvo A. The UCLA-University of Utah epidemiologic survey of autism: the etiologic role of rare diseases. Am J Psychiatry. 1990 Dec;147(12):1614-21. doi: 10.1176/ajp.147.12.1614.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherie Novotny, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Galantamine in people with Autism and Childhood Autism, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252603, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2007.