Galantamine Versus Placebo in Childhood Autism

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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. 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:

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Alliance for Autism Research
• Treatments: Galantamine

Criteria

1. Meets DSM-IV, ADI-R and ADOS-G criteria for autistic disorder

2. Age 5-17 years

3. Outpatients

4. Parent or legal guardian willing to sign informed consent.

5. Male or female patients

6. Patient scores at least a "4" (moderately ill) on the Clinical Global Impression Scale for Autistic Disorder (CGI AD).

7. Children who are minimally or non- verbal as indicated by a score of 50% of an 18 month old on the MacArthur Communicative Development Inventory

Exclusion Criteria:

1. Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.

2. Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).

3. Subjects with active seizure disorder (seizures within the past six months).

4. Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.

5. 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,

• 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.

6. 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.

7. Subjects whose global autism ratings are assessed as being absent, minimal or mild.

8. Treatment within the previous 30 days with any drug known to have a well-defined potential for toxicity to a major organ.

9. Subjects with clinically significant abnormalities in laboratory tests or physical exam.

10. 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.

11. Subjects unable to tolerate taper from psychoactive medication, if specified.

12. Subjects with a history of hypersensitivity or severe side effects associated with the use of galantamine, or other acetylcholinesterase inhibitors.

13. Subjects with a history of prior treatment with galantamine of 4mg/day for 6 weeks.

14. 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.

15. 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.

16. Subjects who reside in a remote geographical area or who do not have regular access to transportation to the clinical facility.

Gender