Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03181399
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2017-04-25
Brief Title:
Diet Treatment Glucose Transporter Type 1 Deficiency G1D
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Dietary Treatment of Glucose Transporter Type 1 Deficiency G1D
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be enrolled To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in addition to IQ language working memory processing speed emotional and behavioral functioning ataxia and other neuropsychological and neurological performance indices in children and adults genetically diagnosed with G1D receiving a regular diet at enrollment
Detailed Description:
This is an open-label single arm trial of orally-administered C7 in G1D Subjects will replace a fixed percentage of their daily caloric intake based on the results of Protocol 1 with C7 for 6 months undergo full evaluation and discontinuation of treatment at a 6 month visit and return for an off-treatment follow up visit 3 months after C7 oil discontinuation for total duration of participation of 9 months Subjects will undergo treatment initiation on a 24-hour inpatient basis During that 24-hr inpatient treatment initiation subjects will have continuous EEG both to monitor for real-time seizure activity for safety and to determine EEG changes secondary outcome before during and after treatment initiation Subjects will undergo clinical evaluation comprehensive blood work ataxia scale rating EEG and neuropsychological testing at baseline 6 months and 9 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NS094257-01A1 | NIH | None | httpsreporternihgovquickSearch1R01NS094257-01A1 |