NCT02111551

Brief 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) .

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

11 months

First QC Date

April 4, 2014

Last Update Submit

June 14, 2016

Conditions

Autism

Keywords

AutismNicotinic agonistCognitionP50Alpha 7

Outcome Measures

Primary Outcomes (4)

  • 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

  • Difference between drug and placebo on the CPT at 30 minutes after administration

    30 minutes after drug administration

  • Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration

    1 hour after drug administration

  • Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration

    2 hours after drug administration

Study Arms (3)

DMXB-A 75 mg

EXPERIMENTAL

DMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level

Drug: DMXB-A 150 mgOther: placebo

DMXB-A 150 mg

EXPERIMENTAL

DMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level

Other: placeboDrug: DMXB-A 75 mg

Sugar Pill

PLACEBO COMPARATOR

placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind

Drug: DMXB-A 150 mgDrug: DMXB-A 75 mg

Interventions

DMXB-A 150 mgDRUG
DMXB-A 75 mgSugar Pill
placeboOTHER
DMXB-A 150 mgDMXB-A 75 mg
DMXB-A 75 mgDRUG
DMXB-A 150 mgSugar Pill

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related 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.

    PMID: 18381905BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Interventions

3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Robert Freedman, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 11, 2014

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

US(1)