ClinicalTrials.gov
ClinicalTrials.gov Menu

A Folinic Acid Intervention for Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01602016
Recruitment Status : Terminated (Non-compliance)
First Posted : May 18, 2012
Results First Posted : November 7, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Arkansas Children's Hospital Research Institute
Information provided by (Responsible Party):
University of Arkansas

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Autism Spectrum Disorder
Autistic Disorder
Autism
Asperger's Syndrome
Pervasive Development Disorders
Interventions: Drug: Folinic Acid and placebo
Drug: Folinic Acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Participants No text entered.

Participant Flow:   Overall Study
    All Participants
STARTED   0 
COMPLETED   0 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
All Participants No text entered.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 0 


  Outcome Measures

1.  Primary:   Language Improvement   [ Time Frame: (baseline and 12 weeks ) ]

2.  Secondary:   Improved Stereotyped Behavior and Improved Social Skills   [ Time Frame: (baseline, 6, and 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tracy Gatlin
Organization: University of Arkansas for Medical Sciences
phone: 501-686-6803
e-mail: tlgatlin@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01602016     History of Changes
Other Study ID Numbers: 136002
First Submitted: May 15, 2012
First Posted: May 18, 2012
Results First Submitted: November 4, 2016
Results First Posted: November 7, 2016
Last Update Posted: October 17, 2017