TSO in Pediatric Autistic Spectrum Disorders

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate and compare the safety and efficacy of Trichuris suis ova (TSO) therapy (versus placebo) in pediatric patients with autism.

Evaluation of the safety and tolerability of treatment with TSO in the target population across the dose range being tested is considered a primary objective, while the primary efficacy objective will be assessed via the change from baseline in the Aberrant Behavior Checklist (ABC) subscale scores.

Dose response will be considered a primary objective as well.

Secondary assessments of efficacy will be assessed via:

• The change from baseline in the Clinical Global Impression scale (CGI-I)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization

Criteria

Inclusion Criteria:

1. Males or females, ages 6 to 17 years, inclusive

2. Diagnosis via Diagnostic and Statistical Manual for Mental Disorders- Forth Edition (DSM-IV)-and confirmed by Autism Diagnostic Observation

Schedule (ADOSI):

3. CGI-Severity score > 4 and ABC irritability score > 18

4. Mental age of > 18 months

5. Weight of at least ** kg

6. Currently psychotropic medication free or on stable dose of psychotropic medication for at least 3 months prior to the study.

7. Willing to comply with the schedule of study visits and protocol requirements

8. Patient and/or guardian have the ability to provide informed consent

Exclusion Criteria:

1. Previous diagnosis of Rett's Disorder, Aspergers Disorder, Childhood Disintegrative Disorder, Fragile X Syndrome, or other disorders on the autism spectrum

2. History of Bipolar Disorder, Psychotic Disorders, or major Depression

3. Seizure within the previous 6 months

4. Patient received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period

5. Patient with history of drug or alcohol abuse within 6 months prior to Screening

6. Patient with evidence of poor compliance with medical advice and instruction including diet or medication

7. Patient is unable or unwilling to swallow study medication suspension

8. Patient with a significant medical condition which puts the patient at risk for study participation and/or for any reason is considered by the Investigator to be an unsuitable candidate to receive TSO or is potentially put at risk by study procedures

9. Patient who has participated in another clinical trial within 30 days of Screening for this trial and/or any experimental treatment for this population

10. Females of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period

11. Females who are pregnant or breastfeeding at the time of enrollment

12. Patients with any of the following laboratory values:

1. White blood cell count ≤ 3,000/mm3 (≤ 3.0 x 109/L) or ≥ 14,000/mm3 (≥14 x 109/L)

2. Platelet count ≤ 100,000/μL (≤100 x 109/L)

3. Serum creatinine ≥ 1.5 mg/dL (≥ 132.6 μmol/L) or >2 x upper limit of normal (ULN)

4. AST (SGOT) or ALT (SGPT) > 2 x ULN

5. Total bilirubin >2 mg/dL (34 μmol/L)

6. Hemoglobin < 9 g/dL