Trial · NCT01602016
A Folinic Acid Intervention for Autism Spectrum Disorders
NCT01602016, Phase 2, Terminated, University of Arkansas; results first posted 2016-11-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Folinic Acid Intervention for Autism Spectrum Disorders. Trials, record NCT01602016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01602016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Folinic Acid Intervention for Autism Spectrum Disorders
- NCT number
- NCT01602016
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 99 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Autism Spectrum Disorder, Autistic Disorder, Autism, Asperger's Syndrome, Pervasive Development Disorders
- Interventions
- Folinic Acid and placebo, Folinic Acid
- First posted
- 2012-05-18
- Last updated
- 2017-10-17
- Results first posted
- 2016-11-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Language Improvement | (baseline and 12 weeks ) | 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. |
| Secondary | Improved Stereotyped Behavior and Improved Social Skills | (baseline, 6, and 12 weeks) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Language Improvement | (baseline and 12 weeks ) | 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. | ||
| SECONDARY | Improved Stereotyped Behavior and Improved Social Skills | (baseline, 6, and 12 weeks) | No data because no patients were analyzed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 0 | |
| Overall Study | COMPLETED | All Participants | 0 | |
| Overall Study | NOT COMPLETED | All Participants | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 0 | 0 |
| Total, serious adverse events | All Participants | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27752075 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01602016
GET https://conductscience.org/api/trials/v1/NCT01602016/registered