Parkinson's DiseasePhase 2NCT06175767
A Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects With Early Parkinson's Disease
A Phase 2 study testing MT101-5 in people with Parkinson's Disease, run by Mthera Pharma Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- MT101-5
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2027to Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- Male or female subjects who are between 30 and 79 years old inclusive with a clinical diagnosis of Parkinson's disease as per UK Brain Bank Criteria for two (2) years or less at screening.
- Hoehn and Yahr I or II at screening.
- Subjects who are newly diagnosed \& currently not on any Parkinson's disease medication (or) subjects who are on stable doses for at least 4 weeks prior to screening on Amantadine or anticholinergics for treatment of Parkinson's disease (1) Note: Subjects that had anti-parkinsonian medication (including levodopa, dopamine agonists, entacapone and monoamine oxidase-B inhibitors) discontinued at least 60 days prior to screening, e.g., for intolerance, may be considered eligible if all other eligibility requirements are met.
- Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) the screening levels should be ≤ 2 times upper limit normal.
- Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements.
Who cannot join
- Subjects will be eligible for enrollment in the study only if they meet NONE of the following criteria:
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
- Subjects with history of neurosurgical intervention for Parkinson's disease.
- Subjects who meet the DSM-V criteria at screening for bipolar disorder, major depressive disorder, psychotic disorders, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation.
- Subjects with clinical diagnosis of dementia (MMSE score <24) as determined by the investigator using Mini-Mental State Examination (MMSE).
- Female subjects who are pregnant or breast feeding.
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- Initiation of any anti-parkinsonian medication (including levodopa, dopamine agonists, entacapone and monoamine oxidase-B inhibitors) for the duration of the trial.
- Initiation of Amantadine or anticholinergics for newly diagnosed subjects or change in the dosage of Amantadine or anticholinergics during the trial for subjects who were on stable doses for 4 weeks prior to screening.
- Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit and for the duration of the trial.
- Subjects who used investigational drugs or devices within 60 days prior to screening or investigational biologics within the last 6 months prior to screening.
- Subjects with a clinically significant medical or surgical condition, including major surgeries within 28 days prior to enrollment.
- The subject has a known allergy or hypersensitivity to any component of the formulation.
- The subject has a history of alcohol abuse (defined as an alcohol intake more than 21 units per week) or a history of drug abuse within the 6 months before study drug administration, or a history of substance abuse deemed significant by the investigator. A unit of alcohol is defined as 240 mL of beer, 120 mL of wine, or 1 single shot of spirits.
- Women of child-bearing age who are sexually active but decline to take proper contraceptive measures during the study period
- Note: To be eligible for the study, Women of childbearing potential (WOCBP) and Women not of childbearing potential are eligible to participate. Both women of childbearing potential and women of no childbearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study (and for 30 days after taking the last dose of investigational product).
- Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or 2 years post-menopausal. All male subjects/partners of WOCBP must agree to consistently and correctly use a condom for the duration of the study and for 30 days after taking the study drug. In addition, subjects may not donate ova or donate sperm for the duration of the study and for 30 days after taking the last dose investigational product.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- MT101-5
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT101-5Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Screening Phase (Day -28 to Day -1, up to 28 days): | Experimental | 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. Receives: Drug: MT101-5 |
| Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks): | Experimental | 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. Receives: Drug: MT101-5 |
| Follow-up Phase (FUV, 4 weeks ± 3 days) | Experimental | The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase. Receives: Drug: MT101-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: Change from baseline to week 12 after the first study drug administration
Incidence of withdrawals due to Adverse Events (AEs)
Incidence of withdrawals due to Adverse Events (AEs) defined above
Measured: Change from baseline to week 12 after the first study drug administration
Incidence of serious adverse events (SAEs)
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.
Measured: Change from baseline to week 12 after the first study drug administration
Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal ideation/suicidal behavior assessment tool. Score ranges from 2 to 25, with the higher number indicating more intense ideation.
Measured: Change from baseline to week 12 after the first study drug administration
Change of blood pressure (both systolic and diastolic blood pressures)
Measured: Change from baseline to week 12 after the first study drug administration
Change of body temperature
Measured: Change from baseline to week 12 after the first study drug administration
Change of respiratory rate
Measured: Change from baseline to week 12 after the first study drug administration
ECG ventricular rate (beats per minute)
Measured: Change from baseline to week 12 after the first study drug administration
ECG PR interval (msec)
Measured: Change from baseline to week 12 after the first study drug administration
ECG QRS interval (msec)
Measured: Change from baseline to week 12 after the first study drug administration
ECG QT interval (msec)
Measured: Change from baseline to week 12 after the first study drug administration
ECG QTc interval (msec)
Measured: Change from baseline to week 12 after the first study drug administration
Secondary outcomes (5)
Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) total score
A multimodal scale assessing both impairment and disability. Score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability
Measured: Change from baseline to week 12 after the first study drug administration
Schwab and England (S&E) Scale total score
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.
Measured: Change from baseline to week 12 after the first study drug administration
Parkinson's Disease Questionnaire (PDQ-39) total score
Patient reported rating scale in Parkinson's disease. Score between 0 and 100. Lower scores reflect better quality of life.
Measured: Change from baseline to week 12 after the first study drug administration
Hoehn and Yahr (H&Y) scale total score
System for describing how the symptoms of Parkinson's disease progress. Score range from 0 to 5. Higher the score worse the outcome.
Measured: Change from baseline to week 12 after the first study drug administration
Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scale score.
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.
Measured: Change from baseline to week 12 after the first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study startSep 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mthera Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175767
- Sponsor's protocol ID
- MT101-PD-002
- Status last verified
- Oct 2026
- First submitted
- 22 Nov 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06175767
- Acronym / sponsor ID
- MT101-PD-002
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mthera Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Screening Phase (Day -28 to Day -1, up to 28 days): | Experimental | Drug: MT101-5Screening 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. |
| Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks): | Experimental | Drug: MT101-5Subjects 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. |
| Follow-up Phase (FUV, 4 weeks ± 3 days) | Experimental | Drug: MT101-5The follow-up phase will consist of a follow-up visit at the end of the Double-Blind Treatment phase. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
- Male or female subjects who are between 30 and 79 years old inclusive with a clinical diagnosis of Parkinson's disease as per UK Brain Bank Criteria for two (2) years or less at screening.
- Hoehn and Yahr I or II at screening.
- Subjects who are newly diagnosed \& currently not on any Parkinson's disease medication (or) subjects who are on stable doses for at least 4 weeks prior to screening on Amantadine or anticholinergics for treatment of Parkinson's disease (1) Note: Subjects that had anti-parkinsonian medication (including levodopa, dopamine agonists, entacapone and monoamine oxidase-B inhibitors) discontinued at least 60 days prior to screening, e.g., for intolerance, may be considered eligible if all other eligibility requirements are met.
- Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) the screening levels should be ≤ 2 times upper limit normal.
Key exclusion criteria (16 listed)
- Subjects will be eligible for enrollment in the study only if they meet NONE of the following criteria:
- Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease).
- Subjects with history of neurosurgical intervention for Parkinson's disease.
- Subjects who meet the DSM-V criteria at screening for bipolar disorder, major depressive disorder, psychotic disorders, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation.
- Subjects with clinical diagnosis of dementia (MMSE score <24) as determined by the investigator using Mini-Mental State Examination (MMSE).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT101-5Tablet | Drug | Follow-up Phase (FUV, 4 weeks ± 3 days), Randomization and Double-Blind Treatment Phase (TV0- TV3, 12 weeks):, Screening Phase (Day -28 to Day -1, up to 28 days): |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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)
Time frame: Change from baseline to week 12 after the first study drug administration
Incidence of withdrawals due to Adverse Events (AEs) defined above
Incidence of serious adverse events (SAEs)
Time frame: 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.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: 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)
Time frame: Change from baseline to week 12 after the first study drug administration
Change of body temperature
Time frame: Change from baseline to week 12 after the first study drug administration
Change of respiratory rate
Time frame: Change from baseline to week 12 after the first study drug administration
ECG ventricular rate (beats per minute)
Time frame: Change from baseline to week 12 after the first study drug administration
ECG PR interval (msec)
Time frame: Change from baseline to week 12 after the first study drug administration
ECG QRS interval (msec)
Time frame: Change from baseline to week 12 after the first study drug administration
ECG QT interval (msec)
Time frame: Change from baseline to week 12 after the first study drug administration
ECG QTc interval (msec)
Time frame: Change from baseline to week 12 after the first study drug administration
5 secondary outcomes
Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) total score
Time frame: Change from baseline to week 12 after the first study drug administration
Schwab and England (S&E) Scale total score
Time frame: Change from baseline to week 12 after the first study drug administration
Parkinson's Disease Questionnaire (PDQ-39) total score
Time frame: Change from baseline to week 12 after the first study drug administration
Hoehn and Yahr (H&Y) scale total score
Time frame: Change from baseline to week 12 after the first study drug administration
Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scale score.
Time frame: Change from baseline to week 12 after the first study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT101-5 in people with Parkinson's Disease, run by Mthera Pharma Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anandkrishnan Balasubramanian ((301) 956-2531, anandb@amarexcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Change from baseline to week 12 after the first study drug administration). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.