A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease
- Registration Number
- NCT06175767
- Lead Sponsor
- Mthera Pharma Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Follow-up Phase (FUV, 4 weeks ± 3 days) MT101-5 The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase. Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks): MT101-5 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. Screening Phase (Day -28 to Day -1, up to 28 days): MT101-5 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. 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.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events (TEAEs) Change from baseline to week 12 after the first study drug administration An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that occurs or is reported by the patient to have occurred, or a worsening of a pre-existing condition. An adverse event may or may not be related to the study treatment.
Incidence of withdrawals due to Adverse Events (AEs) Change from baseline to week 12 after the first study drug administration Incidence of withdrawals due to Adverse Events (AEs) defined above
Columbia-Suicide Severity Rating Scale (C-SSRS) Change from baseline to week 12 after the first study drug administration Suicidal ideation/suicidal behavior assessment tool. Score ranges from 2 to 25, with the higher number indicating more intense ideation.
Change of blood pressure (both systolic and diastolic blood pressures) Change from baseline to week 12 after the first study drug administration Change of respiratory rate Change from baseline to week 12 after the first study drug administration Incidence of serious adverse events (SAEs) Change from baseline to week 12 after the first study drug administration Adverse event that results in death, is life threatening, Requires subject hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Change of body temperature Change from baseline to week 12 after the first study drug administration ECG ventricular rate (beats per minute) Change from baseline to week 12 after the first study drug administration ECG PR interval (msec) Change from baseline to week 12 after the first study drug administration ECG QRS interval (msec) Change from baseline to week 12 after the first study drug administration ECG QT interval (msec) Change from baseline to week 12 after the first study drug administration ECG QTc interval (msec) Change from baseline to week 12 after the first study drug administration
- Secondary Outcome Measures
Name Time Method Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) total score Change from baseline to week 12 after the first study drug administration A multimodal scale assessing both impairment and disability. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability
Schwab and England (S&E) Scale total score Change from baseline to week 12 after the first study drug administration Scale that reflects the speed, ease, and independence with which an individual performs daily activities. Score range from 0% to 100%. Higher the percentage better the outcome.
Parkinson's Disease Questionnaire (PDQ-39) total score Change from baseline to week 12 after the first study drug administration Patient reported rating scale in Parkinson's disease. Score between 0 and 100. Lower scores reflect better quality of life.
Hoehn and Yahr (H&Y) scale total score Change from baseline to week 12 after the first study drug administration System for describing how the symptoms of Parkinson's disease progress. Score range from 0 to 5. Higher the score worse the outcome.
Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scale score. Change from baseline to week 12 after the first study drug administration The CGI measures global severity of illness at a given point in time. Score range from 1 to 7. Higher the score worse the outcome.