AutismPhase 2NCT02140112
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo in Autism Spectrum Disorder
A Phase 2 study testing Trichuris suis ova in people with Autism, run by Coronado Biosciences, Inc. at 5 sites in United States.
Trial summary
This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autism
- What is being tested?
- Trichuris suis ova
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2014to Apr 2015
- Phase
- Phase 2
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients, 5 to 17 years of age
- Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
- Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
- Patients are able and willing to swallow study medication suspension.
Who cannot join
- Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
- Patients who cannot discontinue anti-psychotic medication
- Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
- Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
- Patients who have received helminthic treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Red Oak Psychiatry
Houston, Texas, 77090
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
Baber Research Group
Naperville, Illinois, 60563
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006
Montefiore Medical Center Dept. of Psychiatry, Child Annex
The Bronx, New York, 10467
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, PHASE 2A CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRICHURIS SUIS OVA FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER
This is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.
- Conditions
- Autism
- Being tested
- Trichuris suis ova, Placebo
- Keywords
- T. suis ova, Trichuris suis ova, Autism Spectrum Disorder, ASD
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichuris suis ovaBiological
Also called TSO
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Trichuris suis ova | Active comparator | TSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks Receives: Biological: Trichuris suis ova |
| Placebo | Placebo comparator | Placebo 8 doses every 2 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: A preliminary analysis of data from this trial failed to demonstrate any signal of activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coronado Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140112
- Sponsor's protocol ID
- CNDO 201-101
- Status last verified
- Nov 2015
- First submitted
- 13 May 2014
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, PHASE 2A CROSSOVER STUDY TO ASSESS THE SAFETY AND EFFICACY OF TRICHURIS SUIS OVA FOR THE TREATMENT OF AUTISM SPECTRUM DISORDER
- ClinicalTrials.gov ID
- NCT02140112
- Acronym / sponsor ID
- CNDO 201-101
- Conditions
- Autism
- Keywords
- T. suis ova, Trichuris suis ova, Autism Spectrum Disorder, ASD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A preliminary analysis of data from this trial failed to demonstrate any signal of activity.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Coronado Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 May 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 is a randomized, double-blind, 2-arm, placebo-controlled crossover study in pediatric patients with autism spectrum disorder with all patients receiving 16-weeks of TSO treatment and 16 weeks of placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trichuris suis ova | Active comparator | Biological: Trichuris suis ovaTSO 2500 x 2 doses every 2 weeks followed by TSO 7500 x 6 doses every 2 weeks |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 8 doses every 2 weeks |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients, 5 to 17 years of age
- Patients must fulfill DSM-V diagnostic criteria for autism spectrum disorder ascertained at screening, using a clinical review confirmed by the Autism Diagnosis Observation Schedule - Second edition (ADOS-2)
- Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support patients' adherence to the study procedures must be obtained for patients who are not emancipated. In accordance with Institutional Review Board (IRB) requirements, the patient will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
- Patients are able and willing to swallow study medication suspension.
Key exclusion criteria (5 listed)
- Known diagnosis of syndromal form of Autism (e.g. Rett Syndrome, Childhood Disintegrative Disorder, Fragile X Syndrome, etc.)
- Patients who cannot discontinue anti-psychotic medication
- Patients with current active seizure disorder or who have had a seizure within the last 6 months prior to screening
- Female patient who is pregnant or breastfeeding or wishing to become pregnant during study participation or unwilling to use birth control.
- Patients who have received helminthic treatment
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 |
|---|---|---|
| Trichuris suis ovaAlso: TSO | Biological | Trichuris suis ova |
| Placebo | Other | Placebo |
Primary outcome
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks
Time frame: 36 weeks
Results and safety
The study was stopped early (reason given: A preliminary analysis of data from this trial failed to demonstrate any signal of activity.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trichuris suis ova in people with Autism, run by Coronado Biosciences, Inc. at 5 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 4 inclusion and 5 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 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: A preliminary analysis of data from this trial failed to demonstrate any signal of activity.). 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?
Change from Baseline in Aberrant Behavior Checklist - Irritability (ABC-I) at 16 weeks (time frame: 36 weeks). 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 4 Nov 2015.