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Post Study Continuation of C7 for G1D

Expanded access is currently available for this treatment.
Verified December 2013 by Juan Pascual, University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02018302
First Posted: December 23, 2013
Last Update Posted: December 30, 2013
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan Pascual, University of Texas Southwestern Medical Center
  Purpose
This protocol provides ongoing access to triheptanoin for patients who did complete an initial pilot protocol, and provides the opportunity to collect long-term safety data from patients treated with triheptanoin.

Condition Intervention
Glut1 Deficiency Syndrome Glucose Transporter Type 1 Deficiency Syndrome Drug: Triheptanoin

Study Type: Expanded Access     What is Expanded Access?
Official Title: Post Study Continuation of C7 for G1D

Resource links provided by NLM:


Further study details as provided by Juan Pascual, University of Texas Southwestern Medical Center:

Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Triheptanoin
    Other Names:
    • C7 oil
    • Heptanoate
    • heptanoic acid
Detailed Description:
Only patients who completed the initial pilot study were eligible. The study is ongoing with these patients only.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients enrolled in the pilot trial (UTSW 122010-186)

Exclusion Criteria:

  • Subjects who did not complete the pilot trial (UTSW 122010-186)
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02018302


Contacts
Contact: Dorothy Kelly, MA rare.diseases@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Juan Pascual
Investigators
Principal Investigator: Juan M Pascual, MD, PhD UT Southwestern Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Juan Pascual, Associate Professor, Director of the Rare Brain Disorders Program, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02018302     History of Changes
Other Study ID Numbers: UTSW 082013-016
First Submitted: December 11, 2013
First Posted: December 23, 2013
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Juan Pascual, University of Texas Southwestern Medical Center:
G1D
Glut1 Deficiency
Glucose Transporter Type 1 Deficiency
Glucose Transporter Type I Deficiency

Additional relevant MeSH terms:
Syndrome
Carbohydrate Metabolism, Inborn Errors
Disease
Pathologic Processes
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases