Healthy Volunteer, Autistic Disorder, Asperger's SyndromeNCT01669889
A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome
An observational study of Healthy Volunteer, Autistic Disorder, Asperger's Syndrome, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Autistic Disorder, Asperger's Syndrome
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Dec 2013
- Phase
- Observational
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: High functioning (IQ >70) male adult individuals with Autistic Disorder or Asperger's Syndrome and age and IQ matched healthy male volunteers
Who may be able to join
- Individuals with Autistic Disorder or Asperger's Syndrome:
- Male adults, 18 to 45 years of age inclusive
- Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV
- IQ >70
- Body mass index (BMI) 18 to 35 kg/m2
- Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms
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- Healthy controls:
- Healthy male adults, 18 to 45 years of age inclusive
- IQ >70
- Body mass index (BMI) 18 to 30 kg/m2
Who cannot join
- General exclusion criteria:
- Positive test for drugs of abuse or alcohol
- Confirmed systolic blood pressure >140 or <90 mmHg, and diastolic blood pressure >90 or <50 mmHg
- Resting pulse rate >100 or <40 beats per minute
- Alcohol and/or substance abuse/dependence during the last 12 months
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
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- Additionally for individuals with Autistic Disorder or Asperger's Syndrome:
- History of epilepsy/seizure disorder (except simple febrile seizures)
- Significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study
- Additionally for healthy controls:
- Clinically significant abnormalities in laboratory test results
- History of or current psychiatric, neurological disorder or pervasive developmental disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Los Ageles, California, 90095
Study site
New Haven, Connecticut, 06510
Study site
New York, New York, 10021
About this study
Official title: A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.
This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.
- Medical subject headings
- Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior assessment ratings
Measured: approximately 5 months
Cognition assessment ratings
Measured: approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer, Autistic Disorder, Asperger's SyndromeStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669889
- Sponsor's protocol ID
- BP28421
- Status last verified
- Nov 2016
- First submitted
- 15 Aug 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-drug Study to Explore the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome.
- ClinicalTrials.gov ID
- NCT01669889
- Acronym / sponsor ID
- BP28421
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Aug 2012 (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 multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- High functioning (IQ >70) male adult individuals with Autistic Disorder or Asperger's Syndrome and age and IQ matched healthy male volunteers
Key inclusion criteria (10 listed)
- Male adults, 18 to 45 years of age inclusive
- Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV
- IQ >70
- Body mass index (BMI) 18 to 35 kg/m2
- Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms
Key exclusion criteria (12 listed)
- Positive test for drugs of abuse or alcohol
- Confirmed systolic blood pressure >140 or <90 mmHg, and diastolic blood pressure >90 or <50 mmHg
- Resting pulse rate >100 or <40 beats per minute
- Alcohol and/or substance abuse/dependence during the last 12 months
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Behavior assessment ratings
Time frame: approximately 5 months
Cognition assessment ratings
Time frame: approximately 5 months
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer, Autistic Disorder, Asperger's Syndrome, run by Hoffmann-La Roche at 3 sites 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 10 inclusion and 12 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
Behavior assessment ratings (time frame: approximately 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2016.