Trial Outcomes & Findings for A Folinic Acid Intervention for Autism Spectrum Disorders (NCT NCT01602016)
NCT ID: NCT01602016
Last Updated: 2017-10-17
Results Overview
Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.
TERMINATED
PHASE2
99 participants
(baseline and 12 weeks )
2017-10-17
Participant Flow
The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Participant milestones
| Measure |
All Participants
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|---|---|
|
Overall Study
STARTED
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Folinic Acid Intervention for Autism Spectrum Disorders
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: (baseline and 12 weeks )Population: The study sponsor (UAMS) was unable to completely monitor the study or resolve outstanding queries. The study data cannot be fully validated by the sponsor. The study was placed on Full Clinical Hold by the FDA and terminated by the sponsor as a result of investigator non-compliance.
Language (measured by the receptive and expressive CELF language index, and preschool language scale (PLS), as needed) will be the primary outcome for the study. Both preliminary studies have suggested that the folinic acid intervention will be associated with receptive and expressive language improvements.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: (baseline, 6, and 12 weeks)Population: No data because no patients were analyzed.
Stereotyped behavior (as measured by the OACIS (not at 6 weeks), ASQ, RBS-R, and ABC) and social skills (as measured by the Vineland (not at 6 weeks), ASQ, and SRS) will be the secondary outcomes.
Outcome measures
Outcome data not reported
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tracy Gatlin
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place