Phase I Nicotinic Agonist Treatment Trial for Autism

Autism Clinical Trial

Official title:

Phase I Nicotinic Agonist Treatment Trial for Autism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02111551
• Other study ID #: 14-0614
• Status: Terminated
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: June 14, 2016
• Start date: June 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A [3-(2,4-dimethoxybenzylidene) anabaseine] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• age 18-50

• meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism Diagnostic Observation Schedule

• non-smoking persons

• in good health

Exclusion Criteria:

• persons with estimated verbal and nonverbal IQ < 70.

• abuse of other substances.

• Persons not sufficiently fluent in English to permit testing

• those with history of severe head injury

• Fragile X Syndrome

• Rett Syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Drug:
• DMXB-A 150 mg

Other:
• placebo

Drug:
• DMXB-A 75 mg

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

Freedman R, Olincy A, Buchanan RW, Harris JG, Gold JM, Johnson L, Allensworth D, Guzman-Bonilla A, Clement B, Ball MP, Kutnick J, Pender V, Martin LF, Stevens KE, Wagner BD, Zerbe GO, Soti F, Kem WR. Initial phase 2 trial of a nicotinic agonist in schizophrenia. Am J Psychiatry. 2008 Aug;165(8):1040-7. doi: 10.1176/appi.ajp.2008.07071135. Epub 2008 Apr 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration		2 hours after drug administration	No
Primary	Difference between drug and placebo on the CPT at 30 minutes after administration		30 minutes after drug administration	No
Primary	Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration		1 hour after drug administration	No
Primary	Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration		2 hours after drug administration	No