Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-27 @ 11:28 AM
Study NCT ID:
NCT06175767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2023-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
Sponsor:
Mthera Pharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
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:
A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease. Primary objective of the study is to evaluate the safety and tolerability of MT101-5 400 mg and 600 mg oral tablet total daily dose compared to Placebo in subjects with Parkinson's Disease.
Detailed Description:
The study will include three phases: a 4-week Screening Phase, a 12-week Double-Blind Treatment Phase, and a 4-week Follow-up Phase.
Screening Phase (Day -28 to Day -1, up to 28 days):
Screening phase is designed to determine subject's eligibility to proceed to Randomization and the Treatment Phase of the study. During this phase, a series of assessments will be performed to determine subject eligibility as per inclusion and exclusion criteria.
At the Screening Visit, prior to any study-related procedures, a written informed consent will be obtained from the subject by the Investigator or suitable qualified personnel. Screening procedures will be conducted per the study schedule of events. All screening information will be documented in the case report forms.
Subjects who meet eligibility criteria, but have some abnormal laboratory values, based on PI review a repeat laboratory sample may be collected. The repeat laboratory reports should be reviewed by the PI to confirm eligibility prior to randomization.
Subjects who fail to meet eligibility criteria during the Screening phase will be considered screen failures and will be exited from the study. Subjects who meet the eligibility criteria will be scheduled for randomization visit.
Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks):
Subjects who have successfully completed the Screening phase will enter the Randomization and Double-Blind treatment phase of the study. Subjects will take the assigned randomized treatment, MT101-5 at 400 mg, 600 mg or placebo for 12 weeks. MT101-5 and matching placebo are oral tablets that will be taken as six tablets two times a day (b.i.d.) at least 2 hours before or 2 hours after meal in the morning and evening daily during this study.
Randomization/Treatment Visit 0 (TV0):
On Day 0 prior to randomization, the subject's continued eligibility will be evaluated. Subjects who continue to be eligible will be randomized in a 1:1:1 ratio to one of the following treatment groups and assigned the study treatment kit:
* Group 1: MT101-5 400 mg divided b.i.d. (Total daily dose of 400 mg, combination of four 50 mg MT101-5 tablets and two placebo tablets, taken as six tablets two times daily at least 2 hours before or 2 hours after meal).
* Group 2: MT101-5 600 mg divided b.i.d. (Total daily dose of 600 mg, 50 mg tablets taken as six tablets two times daily at least 2 hours before or 2 hours after meal).
* Group 3: Placebo tablet (0 mg MT101-5) divided b.i.d. (Total daily dose of 0 mg, 0 mg taken as six placebo tablets two times daily at least 2 hours before or 2 hours after meal).
Treatment Visits 1 (TV1) through 3 (TV3):
Clinic treatment visits TV1 through TV3 will be conducted every four (4) weeks (± window periods). During each of these visits, study evaluations will be conducted per the study schedule of events and sufficient supply of MT101-5 or placebo till the next treatment visit will be dispensed.
Treatment Visit 3 (TV3) will be the end of treatment (EOT) clinic visit. Study evaluations, review of the adverse events, concomitant medications and final study treatment accountability will be conducted.
Follow-up Phase (FUV, 4 weeks ± 3 days)
The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase.
Screening Phase (Day -28 to Day -1, up to 28 days):
Screening phase is designed to determine subject's eligibility to proceed to Randomization and the Treatment Phase of the study. During this phase, a series of assessments will be performed to determine subject eligibility as per inclusion and exclusion criteria.
At the Screening Visit, prior to any study-related procedures, a written informed consent will be obtained from the subject by the Investigator or suitable qualified personnel. Screening procedures will be conducted per the study schedule of events. All screening information will be documented in the case report forms.
Subjects who meet eligibility criteria, but have some abnormal laboratory values, based on PI review a repeat laboratory sample may be collected. The repeat laboratory reports should be reviewed by the PI to confirm eligibility prior to randomization.
Subjects who fail to meet eligibility criteria during the Screening phase will be considered screen failures and will be exited from the study. Subjects who meet the eligibility criteria will be scheduled for randomization visit.
Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks):
Subjects who have successfully completed the Screening phase will enter the Randomization and Double-Blind treatment phase of the study. Subjects will take the assigned randomized treatment, MT101-5 at 400 mg, 600 mg or placebo for 12 weeks. MT101-5 and matching placebo are oral tablets that will be taken as six tablets two times a day (b.i.d.) at least 2 hours before or 2 hours after meal in the morning and evening daily during this study.
Randomization/Treatment Visit 0 (TV0):
On Day 0 prior to randomization, the subject's continued eligibility will be evaluated. Subjects who continue to be eligible will be randomized in a 1:1:1 ratio to one of the following treatment groups and assigned the study treatment kit:
* Group 1: MT101-5 400 mg divided b.i.d. (Total daily dose of 400 mg, combination of four 50 mg MT101-5 tablets and two placebo tablets, taken as six tablets two times daily at least 2 hours before or 2 hours after meal).
* Group 2: MT101-5 600 mg divided b.i.d. (Total daily dose of 600 mg, 50 mg tablets taken as six tablets two times daily at least 2 hours before or 2 hours after meal).
* Group 3: Placebo tablet (0 mg MT101-5) divided b.i.d. (Total daily dose of 0 mg, 0 mg taken as six placebo tablets two times daily at least 2 hours before or 2 hours after meal).
Treatment Visits 1 (TV1) through 3 (TV3):
Clinic treatment visits TV1 through TV3 will be conducted every four (4) weeks (± window periods). During each of these visits, study evaluations will be conducted per the study schedule of events and sufficient supply of MT101-5 or placebo till the next treatment visit will be dispensed.
Treatment Visit 3 (TV3) will be the end of treatment (EOT) clinic visit. Study evaluations, review of the adverse events, concomitant medications and final study treatment accountability will be conducted.
Follow-up Phase (FUV, 4 weeks ± 3 days)
The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: