Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412653
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-29
Brief Title:
Prospective Pilot Trial to Address Feasibility and Safety of Oral Zinc in GNAO1 Associated Disorders
Sponsor:
Childrens University Hospital Cologne Germany
Organization:
Childrens University Hospital Cologne Germany
Study Overview
Official Title:
Prospective Pilot Trial to Address the Feasibility and Safety of Treatment With Oral Zinc in GNAO1 Associated Disorders
Status:
RECRUITING
Status Verified Date:
2024-08
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:
ZINCGNAO1
Brief Summary:
The goal of this clinical trial is to investigate feasibility and safety of an oral therapy with zinc in patients affected by Guanine nucleotide-binding protein Go subunit alpha GNAO1 associated disorders
The main questions it aims to answer are
Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy
Are there potential changes in general motor skills general behaviour and well being daynight rhythm level of dyskinesia and dystonia frequency of seizures quality of life and changes in the microbiome of the patients
Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial
The main questions it aims to answer are
Is a daily oral therapy with zinc in GNAO1 associated disorders a safe and feasible therapy
Are there potential changes in general motor skills general behaviour and well being daynight rhythm level of dyskinesia and dystonia frequency of seizures quality of life and changes in the microbiome of the patients
Participants with GNAO1 associated disorders will be given an oral zinc therapy for 6 month and will be assessed in 3 visits and 2 phone calls within this trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None