Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402123
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-02
Brief Title:
A Phase 2b Study of Zagociguat in Patients with MELAS
Sponsor:
Tisento Therapeutics
Organization:
Tisento Therapeutics
Study Overview
Official Title:
Phase 2b Randomized Double-blind Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of Zagociguat in Participants with MELAS PRIZM
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PRIZM
Brief Summary:
PRIZM is a Phase 2b randomized double-blind placebo-controlled 3-treatment 2-period crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS
Detailed Description:
The goal of this clinical trial is to learn about the effectiveness of zagociguat in patients with MELAS The main questions it aims to answer are
Does zagociguat improve fatigue in patients with MELAS
Does zagociguat improve cognitive performance in patients with MELAS
What is the safety and tolerability profile of zagociguat
The PRIZM study is evaluating 2 dose levels of zagociguat in a crossover design consisting of two 12-week treatment periods separated by a 4-week washout Patients will be screened and if eligible randomly assigned either to receive placebo in period 1 followed by active drug in period 2 OR to receive active drug in period 1 followed by placebo in period 2 Study medication is a once daily oral tablet and will be provided at the clinic andor shipped to the participants home Clinic visits will occur at screening and Week 1 and Week 12 of each treatment period Visits at Week 4 and Week 8 of both crossover periods will either be in clinic or optionally at the participants home Study assessments will be conducted weekly on a phone app and a separate tablet and additional assessments will be conducted during visits Patients who complete the study will be eligible for an open label extension study
Does zagociguat improve fatigue in patients with MELAS
Does zagociguat improve cognitive performance in patients with MELAS
What is the safety and tolerability profile of zagociguat
The PRIZM study is evaluating 2 dose levels of zagociguat in a crossover design consisting of two 12-week treatment periods separated by a 4-week washout Patients will be screened and if eligible randomly assigned either to receive placebo in period 1 followed by active drug in period 2 OR to receive active drug in period 1 followed by placebo in period 2 Study medication is a once daily oral tablet and will be provided at the clinic andor shipped to the participants home Clinic visits will occur at screening and Week 1 and Week 12 of each treatment period Visits at Week 4 and Week 8 of both crossover periods will either be in clinic or optionally at the participants home Study assessments will be conducted weekly on a phone app and a separate tablet and additional assessments will be conducted during visits Patients who complete the study will be eligible for an open label extension study
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