Parkinson DiseasePhase 2NCT04220762
A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease Patients
A Phase 2 study testing WIN-1001X in people with Parkinson Disease, run by Medi Help Line at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- WIN-1001X
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2020to Sep 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects ≥30 years old at the time of informed consent
- Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)
- Modified Hoehn and Yahr stage ≤ 3.0
- K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)
- Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
- MDS UPDRS Part Ⅱ+Part Ⅲ score ≥18 at baseline (visit 2)
- Subjects who have voluntarily determined to participate in this study and signed the written informed consent form
Who cannot join
- Atypical or secondary parkinsonism or benign tremulous parkinsonism
- History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
- In case the investigators determine the symptom control is difficult with placebo
- Hypersensitivity to herbal medicine
- Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination
- Any disorder that may affect the absorption, distribution, metabolism, and excretion of drugs
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- History of surgical treatment for Parkinson's disease
- Subjects who have been administered another investigational product within 30 days prior to screening
- Female subjects who are pregnant or lactating, or who have child-bearing potential (i.e., (i) those who are not surgically non-infertile, or (ii) who are not using adequate contraceptive methods [including at least one of the barrier methods], or (iii) who are not sexually abstinent, or (iv) for whom at least 2 years have not elapsed since their last menstruation)
- History of chronic alcohol or drug abuse within last 6 months
- Subjects who are otherwise considered to be ineligible for this study on investigators' judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeouido St.Mary's Hospital
Yeongdeungpo-dong, Seoul, 04537
Yoon-Sang Oh
About this study
Official title: A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.
Read the detailed description
The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks.
The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score.
- Conditions
- Parkinson Disease
- Being tested
- WIN-1001X, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIN-1001XDrug
This study has been designed as a randomized, double-blind, and placebo-controlled study.
Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
PlaceboDrug
This study has been designed as a randomized, double-blind, and placebo-controlled study.
Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated.
| Study group | Role | What they receive |
|---|---|---|
| Test Group 1 | Experimental | The randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. Receives: Drug: WIN-1001X |
| Test Group 2 | Experimental | The randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. Receives: Drug: WIN-1001X |
| Test Group 3 | Experimental | The randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. Receives: Drug: WIN-1001X |
| Placebo group | Placebo comparator | The randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MDS UPDRS Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Measured: From baseline (0d) after administration of the investigational product for 12 weeks
Secondary outcomes (8)
Change in the MDS UPDRS Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Measured: After administration of the investigational product for 4 and 8 weeks
Change in the MDS UPDRS Part Ⅰ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I. MDS-UPDRS Part I measures non-motor experiences of daily living. Part I consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Measured: After administration of the investigational product for 4, 8, and 12 weeks
Change in the MDS UPDRS Part Ⅱ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. MDS-UPDRS Part II measures motor experiences of daily living. Part II consists of 13 questions/evaluations, and each question is anchored with five response scale from 0(normal) to 4(severe).
Measured: After administration of the investigational product for 4, 8, and 12 weeks
Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I+II+III. MDS-UPDRS Part I measures non-motor experiences of daily living, Part II measures motor experiences of daily living and Part III measures motor examination. Part I and II each consists of 13 questions/evaluations and Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
Measured: After administration of the investigational product for 4, 8, and 12 weeks
Change in the Modified Hoehn and Yahr scale
The Hoehn and Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The Hoehn and Yahr scale includes stages 1 through 5, with addition of stages 1.5 and 2.5 to help describe the intermediate course of the disease. The higher the score, the more severe the symptoms of Parkinson's disease progress.
Measured: After administration of the investigational product for 4, 8, and 12 weeks
Changes in each and total scores of K-NMSS
Korean version of Novel Non-Motor Symptoms Scale for Parkinson's Disease is 30-item scale containing nine dimensions: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems, attention/memory, gastrointestinal, urinary, sexual function and miscellany. Each symptoms are scored with severity (0=none, 1=mild, 2=moderate) and frequency (1=rarely, 2=often, 3=frequent, 4=very frequent). The final scores are calculated as severity score x frequency score. The higher the score, the severe the symptoms.
Measured: After administration of the investigational product for 4 and 12 weeks
Change in the K-MoCA
The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment. It is a 30-point test consisting of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points and a score of 26 or above is considered normal.
Measured: After administration of the investigational product for 4 and 12 weeks
Changes in the summary index and total scores of the K-PDQ-39
The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assessment is carried out across the 8 quality of life dimensions; activities of daily living, attention \& working memory, cognition, communication, depression, functional mobility, quality of life, social relationships and social support. All items are scored from 0 (never) to 4 (always). Dimension score is then calculated by sum of scores of each item in the dimension divided by the maximum possible socre of all the items in the dimension, multiplied by 100. Lower dimension score reflects better quality of life.
Measured: After administration of the investigational product for 4 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start21 Jan 2020
- Primary completionJun 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medi Help Line
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ok Nam Park, Study director, Medihelpline Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220762
- Sponsor's protocol ID
- WIN-1001X-P2
- Status last verified
- Feb 2021
- First submitted
- 17 Dec 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT04220762
- Acronym / sponsor ID
- WIN-1001X-P2
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Medi Help LineUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 7 Jan 2020 (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.
The purpose of this study is to determine the optimal dose of WIN-1001X for its therapeutic confirmatory study by comparing and evaluating the efficacy and safety of each dose group by conducting a therapeutic exploratory study on three dose groups of WIN-1001X 400 mg, 800 mg, and 1200 mg, and placebo group in patients with early Parkinson's disease.
Detailed description
The primary objective of this study is to evaluate the difference in the change of MDS UPDRS Part Ⅲ between WIN-1001X 400 mg, 800 mg, and 1200 mg as the test drugs compared to placebo as the control drug after administering them for 12 weeks.
The secondary objectives of this study are to evaluate the therapeutic efficacy and safety of the 3 dose groups of WIN-1001X compared to placebo group by assessing the changes in MDS UPDRS Part Ⅲ after administering the investigational products for 4 and 8 weeks, the changes in MDS UPDRS Part Ⅰ, Part Ⅱ, Part Ⅰ+Part Ⅱ+Part Ⅲ, and Modified Hoehn and Yahr scale after administering for 4, 8, and 12 weeks, the changes in K-NMSS (Non-Motor Symptoms Scale), K-MoCA (Korean-Montreal Cognitive Assessment), K-PDQ-39 (Parkinson's Disease Questionnaire) score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group 1 | Experimental | Drug: WIN-1001XThe randomized patients are administered 3 tablets of the investigational product (400mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. |
| Test Group 2 | Experimental | Drug: WIN-1001XThe randomized patients are administered 3 tablets of the investigational product (800mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. |
| Test Group 3 | Experimental | Drug: WIN-1001XThe randomized patients are administered 3 tablets of the investigational product (1200mg) twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. |
| Placebo group | Placebo comparator | Drug: PlaceboThe randomized patients are administered 3 tablets of the placebo drug twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects ≥30 years old at the time of informed consent
- Subjects diagnosed with Parkinson's disease satisfying the UKPDSBB (United Kingdom Parkinson's Disease Society Brain Bank) Clinical Diagnostic Criteria and showing decreased dopamine transporters in the dopamine transporter imaging (e.g.: ¹⁸F-FP-CIT PET, etc.)
- Modified Hoehn and Yahr stage ≤ 3.0
- K-MMSE (Korean Mini-Mental State Examination) score ≥20 at the screening visit (visit 1)
- Subjects who can understand and follow the instructions on this clinical study, and fully participate in the clinical study
Key exclusion criteria (11 listed)
- Atypical or secondary parkinsonism or benign tremulous parkinsonism
- History of treatments with levodopa, dopamine agonists, anticholinergics, MAO-B inhibitors, COMT inhibitors, amantadine, or NMDA receptor antagonists (However, subjects who have not been administered such drugs for at least 6 months in a row and have no history of treatment within 4 weeks prior to their written consent can be enrolled)
- In case the investigators determine the symptom control is difficult with placebo
- Hypersensitivity to herbal medicine
- Subjects with dementia whose K-MMSE score is ≤19, severe psychopathy requiring treatment or hallucination
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 |
|---|---|---|
| WIN-1001XThis study has been designed as a randomized, double-blind, and placebo-controlled study. Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. | Drug | Test Group 1, Test Group 2, Test Group 3 |
| PlaceboThis study has been designed as a randomized, double-blind, and placebo-controlled study. Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated. | Drug | Placebo group |
Primary outcome
Change in MDS UPDRS Part Ⅲ
Time frame: From baseline (0d) after administration of the investigational product for 12 weeks
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. MDS-UPDRS Part III measures motor examination. Part III consists of 33 scores based on 18 items, and each question is anchored with five response scale from 0(normal) to 4(severe).
8 secondary outcomes
Change in the MDS UPDRS Part Ⅲ
Time frame: After administration of the investigational product for 4 and 8 weeks
Change in the MDS UPDRS Part Ⅰ
Time frame: After administration of the investigational product for 4, 8, and 12 weeks
Change in the MDS UPDRS Part Ⅱ
Time frame: After administration of the investigational product for 4, 8, and 12 weeks
Change in the MDS UPDRS Part Ⅰ+Part Ⅱ+Part Ⅲ
Time frame: After administration of the investigational product for 4, 8, and 12 weeks
Change in the Modified Hoehn and Yahr scale
Time frame: After administration of the investigational product for 4, 8, and 12 weeks
Changes in each and total scores of K-NMSS
Time frame: After administration of the investigational product for 4 and 12 weeks
Change in the K-MoCA
Time frame: After administration of the investigational product for 4 and 12 weeks
Changes in the summary index and total scores of the K-PDQ-39
Time frame: After administration of the investigational product for 4 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ok Nam Park study director
Medihelpline Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WIN-1001X in people with Parkinson Disease, run by Medi Help Line at 1 site in South Korea.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joong-Seok Kim (+82-1588-1511, neuronet@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS UPDRS Part Ⅲ (time frame: From baseline (0d) after administration of the investigational product for 12 weeks). 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 24 Feb 2021.