AutismPhase 1NCT02111551
Phase I Nicotinic Agonist Treatment Trial for Autism
A Phase 1 study testing DMXB-A 150 mg and DMXB-A 75 mg in people with Autism, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Autism
- What is being tested?
- DMXB-A 150 mg and DMXB-A 75 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to May 2016
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
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) .
- Conditions
- Autism
- Being tested
- DMXB-A 150 mg, placebo, DMXB-A 75 mg
- Keywords
- Autism, Nicotinic agonist, Cognition, P50, Alpha 7
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DMXB-A 150 mgDrug
placeboOther
DMXB-A 75 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: DMXB-A 150 mg; Other: 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 Receives: Other: placebo; Drug: DMXB-A 75 mg |
| Sugar Pill | Placebo comparator | placebo comparator dose followed by a second placebo dose at 2 hours to maintain blind Receives: Drug: DMXB-A 150 mg; Drug: DMXB-A 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration
Measured: 2 hours after drug administration
Difference between drug and placebo on the CPT at 30 minutes after administration
Measured: 30 minutes after drug administration
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
Measured: 1 hour after drug administration
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
Measured: 2 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: difficult to find participants and no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Freedman, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111551
- Sponsor's protocol ID
- 14-0614
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2014
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18381905
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Nicotinic Agonist Treatment Trial for Autism
- ClinicalTrials.gov ID
- NCT02111551
- Acronym / sponsor ID
- 14-0614
- Conditions
- Autism
- Keywords
- Autism, Nicotinic agonist, Cognition, P50, Alpha 7
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to find participants and no funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Apr 2014 (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.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DMXB-A 75 mg | Experimental | Drug: DMXB-A 150 mg, Other: placeboDMXB-A 75 mg dose followed by a second dose of 37.5 mg at 2 hours to maintain the blood level |
| DMXB-A 150 mg | Experimental | Other: placebo, Drug: DMXB-A 75 mgDMXB-A 150 mg followed by a second dose of 75 mg at 2 hours to maintain the blood level |
| Sugar Pill | Placebo comparator | Drug: DMXB-A 150 mg, Drug: DMXB-A 75 mgplacebo comparator dose followed by a second placebo dose at 2 hours to maintain blind |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| DMXB-A 150 mg | Drug | DMXB-A 75 mg, Sugar Pill |
| placebo | Other | DMXB-A 150 mg, DMXB-A 75 mg |
| DMXB-A 75 mg | Drug | DMXB-A 150 mg, Sugar Pill |
Primary outcome
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration
Time frame: 2 hours after drug administration
Difference between drug and placebo on the CPT at 30 minutes after administration
Time frame: 30 minutes after drug administration
Difference between the P50 auditory evoked potential test/conditioning ratio 1 hour after administration
Time frame: 1 hour after drug administration
Difference between placebo and drug on the Social Responsiveness scale 2 hours after administration
Time frame: 2 hours after drug administration
Results and safety
The study was stopped early (reason given: difficult to find participants and no funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
- Background: PubMed 18381905Freedman 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.
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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.
Robert Freedman, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DMXB-A 150 mg and DMXB-A 75 mg in people with Autism, run by University of Colorado, Denver 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Jun 2016. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: difficult to find participants and no funding). Results are not available in the source record.
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?
Difference between drug and placebo on theTotal Scale Score on the repeatable Battery for the Assessment of neuropsychological Status at 2 hours after administration (time frame: 2 hours after drug administration). The study lists 4 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 NCT02111551, which also lists 1 linked publication.
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 16 Jun 2016.