NCT01040221

Brief Summary

The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

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

December 24, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2009

Completed
2.8 years until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.6 years

First QC Date

December 24, 2009

Last Update Submit

March 30, 2018

Conditions

Autism

Keywords

Autism, Autism Spectrum DisorderASDTrichuris Suis OvaTSOTreatmentClinical Trial

Outcome Measures

Primary Outcomes (3)

  • Yale-Brown Obsessive Compulsive Scale (YBOCS): to measure repetitive behaviors

    baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks

  • Aberrant Behavior Checklist (ABC): to measure aggression and irritability

    baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks

  • Clinical Global Impression - Improvement (CGI-I): to measure global functioning

    baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks

Secondary Outcomes (1)

  • Repetitive Behavior Scale-Revised.

    baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks

Study Arms (2)

Trichuris Suis Ova (TSO)

EXPERIMENTAL

the eggs of intestinal helminthes (trichuris suis ova) administered as 2500 ova doses every two weeks.

Drug: Trichuris Suis Ova

Placebo

PLACEBO COMPARATOR

placebo dosage received every two weeks.

Drug: Trichuris Suis Ova

Interventions

Trichuris Suis OvaDRUG

TSO will be administered in vials prepared by Coronado Biosciences. Vials will be diluted with a commercial drink and given to subjects to ingest. Subjects will receive a dose of 2500 ova every two weeks for 12 weeks.

PlaceboTrichuris Suis Ova (TSO)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35, inclusive, at the time of consent
  • Outpatient
  • Meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM-IV-TR, and supported by the ADOS or ADI-R.
  • Have an IQ of 70 or greater
  • Participants who are taking other medications prior to enrollment must be on a stable dose of concomitant medication, including psychotropic, anticonvulsant, or sleep aid for at least 3 months prior to baseline ratings
  • Be judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subjects and guardians)
  • Have a personal or family history of allergies.

You may not qualify if:

  • History of Bipolar disorder or Psychotic Disorders (e.g. schizophrenia or schizoaffective disorders).
  • Previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
  • Uncontrolled seizure disorders (seizures within the past 6 months)
  • Pregnant or breast feeding at screening, or at any time during the study
  • Chronic medical illness that would interfere with or contraindicate participation in the study, or clinically significant abnormalities in baseline laboratory testing or physical exam.
  • Treatment in the last 12 weeks with cyclosporine, methotrexate, infliximab or immunomodulatory agents
  • Treatment in the last 2 weeks with antibiotics, antifungal or antiparasitic medications
  • Presence of any organic or systemic disease or need for a therapeutic intervention, which would confound the interpretation of results.
  • History of previous treatment with Trichuris Suis Ova (TSO).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

Related Publications (2)

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

  • Hollander E, Uzunova G, Taylor BP, Noone R, Racine E, Doernberg E, Freeman K, Ferretti CJ. Randomized crossover feasibility trial of helminthic Trichuris suis ova versus placebo for repetitive behaviors in adult autism spectrum disorder. World J Biol Psychiatry. 2020 Apr;21(4):291-299. doi: 10.1080/15622975.2018.1523561. Epub 2018 Nov 16.

    PMID: 30230399DERIVED

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Eric Hollander, MD

    Montefiore Medical Center/Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 24, 2009

First Posted

December 29, 2009

Study Start

November 1, 2012

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations

US(1)