University of California, San Diego (UCSD) Suramin Autism Treatment-1 (SAT1) Trial (SAT1)
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|ClinicalTrials.gov Identifier: NCT02508259|
Recruitment Status : Completed
First Posted : July 24, 2015
Results First Posted : July 16, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Suramin Drug: Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The UCSD Suramin Autism Treatment-1 (SAT1) Trial|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||April 2016|
Active Comparator: Suramin
20 mg/kg suramin in 50 ml of saline by intravenous infusion over 30 minutes
20 mg/kg IV in 50 ml saline over 30 minutes
Other Name: Germanin
Placebo Comparator: Saline
50 ml of saline by intravenous infusion over 30 minutes
50 ml IV over 30 minutes
Other Name: Normal saline
- Autism Diagnostic Observation Schedule, 2nd Edition (ADOS2) [ Time Frame: 6 weeks compared to baseline ]ADOS2 comparison scores are units on a scale of 0-10. A score of 7-10 was required for enrollment. A score of 7-10 is diagnostic for autism spectrum disorder (ASD). The higher the score, the more severe the core symptoms of autism spectrum disorder. Scores of 6 and below are considered off the ASD spectrum.
- Expressive Language [ Time Frame: 6 weeks compared to baseline ]Expressive One Word Picture Vocabulary Test (EOWPVT) scores are normalized for age. Typical language development produces a mean score of 100 with a standard deviation of 15. Outcomes for EOWPVT were expressed as the mean of the child-specific difference before and 6-weeks after treatment. For example, if the 6-week standard EOWPVT score was 59.6 and the baseline score was 63.8, the difference is -4.2 (= 59.6 - 63.8). A decrease in score at 6 weeks would corresponds to a decrease in language performance, while an increase, a positive difference, would reflect an increase.
- Aberrant Behavior Checklist (ABC) [ Time Frame: 6 weeks compared to baseline ]The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. Stereotypy is reported, and scores range from 0 to 21, with higher scores indicating worse behavior. A negative difference corresponds to decreased symptoms after treatment. A positive difference corresponds to increased symptoms after treatment.
- Autism Treatment Evaluation Checklist (ATEC) [ Time Frame: 6 weeks ]The reported value is the Language sub-score of the ATEC, and the range for the language sub-score is 0-20. The higher the score, the worse the disability. Outcomes were measured at 6 weeks after treatment compared to baseline. A negative difference corresponds to a decrease in language disability, i.e an improvement in speech and language. A positive difference reflects an increase in language disability, i.e. a decrease in speech and language.
- The Clinical Global Impression - Improvement Scale (CGI-I) [ Time Frame: Overall ASD symptoms at 6 weeks ]The CGI-I is scale that ranges from 1-7, reflecting the change in core autism behaviors after treatment. 1 is much improved, 4 is unchanged, and 7 is much worse.
- Repetitive Behavior Questionnaire [ Time Frame: 6 weeks compared to baseline ]Total repetitive behavior was assessed using the Repetitive behavior questionnaire (RBQ), which has a scale from 0-87. Higher scores correspond to more severe repetitive behavior. Outcomes were analyzed as the difference in the score 6 weeks after treatment compared to baseline. A negative difference corresponds to improved behavior compared to baseline. A positive difference corresponds to worse behavior.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508259
|United States, California|
|University of California, San Diego School of Medicine|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Robert K Naviaux, MD, PhD||University of California, San Diego|