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Post Study Continuation of C7 for G1D

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: NCT02018302
Expanded Access Status : No longer available
First Posted : December 23, 2013
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Juan Pascual, University of Texas Southwestern Medical Center

Brief Summary:
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 or disease Intervention/treatment
Glut1 Deficiency Syndrome Glucose Transporter Type 1 Deficiency Syndrome Drug: Triheptanoin

Detailed Description:
Only patients who completed the initial pilot study were eligible. The study is ongoing with these patients only.

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



Intervention Details:
  • Drug: Triheptanoin
    Other Names:
    • C7 oil
    • Heptanoate
    • heptanoic acid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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)

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


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

Additional Information:
Publications:

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Responsible Party: Juan Pascual, Associate Professor, Director of the Rare Brain Disorders Program, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02018302    
Other Study ID Numbers: UTSW 082013-016
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
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:
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Syndrome
Disease
Pathologic Processes