In short
Clinical trials investigating Zinc Acetate Dihydrate are studying oral zinc treatment in people with GNAO1 associated disorders. The main goals are to check feasibility and safety, and to see whether patients can take the planned doses as scheduled.
Key points
- Clinical trials investigating Zinc Acetate Dihydrate in the provided data focus on people with GNAO1 associated disorders. The study is a Phase 2 interventional trial and has been completed. It looked at whether oral zinc treatment could be given in the planned way and whether it was safe. Feasibility was measured by how many days the zinc was taken in the correct dose, with 80% of scheduled days used as the target. Safety was checked by regular review of adverse events. The trial enrolled 12 people.
Trial overview
The available trial of Zinc Acetate Dihydrate was a prospective pilot study called ZINCGNAO1, designed to address the feasibility and safety of oral zinc treatment in people with GNAO1 associated disorders.
This was an interventional study, which means the researchers actively gave the treatment and then observed what happened.
Who was studied
The target population was patients affected by GNAO1 associated disorders.
The trial enrolled 12 participants.
What the trial tested
The study tested oral zinc therapy using Wilzin 50 mg hard capsules and Wilzin 25 mg hard capsules, both given in a total planned dose of 150 mg by mouth, nasogastric tube, or percutaneous endoscopic gastrostomy tube.
In simple terms, the trial was checking whether this zinc treatment plan could be followed in real life for people with GNAO1 associated disorders.
Trial phase and design
This study was a Phase 2 trial.
Phase 2 studies usually look more closely at safety and early signs of benefit after earlier testing, although this source only states the phase and the study goals, not treatment benefit results.
The study was completed.
Outcomes measured
The main feasibility outcome was measured by the actual days on which zinc was taken in the correct dose.
The study considered the treatment feasible if the planned dose was taken on at least 80% of the days.
The main safety outcome was regular evaluation of adverse events, meaning unwanted medical problems recorded during the study.
Study status and size
The trial status was completed.
Because this was a small pilot trial with 12 participants, it was mainly meant to learn whether the study plan was practical and safe enough for future research.