Parkinson's DiseasePhase 2NCT02939391
A Study of KW-6356 in Subjects With Early Parkinson's Disease
A Phase 2 study testing KW-6356 in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 7 sites in Japan.
Trial summary
The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- KW-6356
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 7 sitesJapan
- Study dates
- Sep 2016to 8 Dec 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
- Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
- MDS-UPDRS part III score of ≥ 15
Who cannot join
- Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
- Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period.
- Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more.
- Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS).
- Either of the following criteria consecutively at screening and enrollment;
- Resting Pulse > 100 bpm
Show all 10Show fewer
- Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg
- Significant dementia or a Mini-Mental State Examination (MMSE) score of ≤ 23.
- Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
- Anyone otherwise considered unsuitable for the study by the investigator or sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Study site
Akashi, Hyōgo
Study site
Asahikawa, Hokkaido
Study site
Fujisawa, Kanagawa
Study site
Kyoto
Study site
Nakano City, Tokyo
Study site
Setagaya City, Tokyo
Study site
Suita, Osaka
About this study
Official title: An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
- Conditions
- Parkinson's Disease
- Being tested
- KW-6356, 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.
KW-6356Drug
Oral administration
KW-6356Drug
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| KW-6356 Low Dose | Experimental | Oral administration Receives: Drug: KW-6356 |
| KW-6356 High Dose | Experimental | Oral administration Receives: Drug: KW-6356 |
| Placebo | Placebo comparator | Oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
Measured: Up to 12 weeks after dosing
Secondary outcomes (6)
Clinical global impression-improvement(CGI-I) score
Measured: Week 12
Patient global impression-improvement(PGI-I) score
Measured: Week 12
Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Measured: Up to 12 weeks after dosing
Number and percentage of subjects with treatment-emergent adverse events
Measured: Up to 14 weeks after dosing
Profiles of pharmacokinetics of plasma KHK6356 concentration
Measured: 2, 4, 8 and 12 weeks after dosing
Change from baseline in the MDS-UPDRS subitem and total scores
Measured: Up to 12 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion22 Nov 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939391
- Sponsor's protocol ID
- 6356-002
- Status last verified
- Mar 2018
- First submitted
- 17 Oct 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maeda T, Kimura T, Sugiyama K, Yamada K, Hiraiwa R, Nishi M, Hattori N; 6356-002 study group. Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease. Parkinsonism Relat Disord. 2023 Dec;117:105907. doi: 10.1016/j.parkreldis.2023.105907. Epub 2023 Oct 31.
PubMed 37948832
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02939391
- Acronym / sponsor ID
- 6356-002
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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 primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KW-6356 Low Dose | Experimental | Drug: KW-6356Oral administration |
| KW-6356 High Dose | Experimental | Drug: KW-6356Oral administration |
| Placebo | Placebo comparator | Drug: PlaceboOral administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
- Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
- MDS-UPDRS part III score of ≥ 15
Key exclusion criteria (10 listed)
- Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
- Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period.
- Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more.
- Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS).
- Either of the following criteria consecutively at screening and enrollment;
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 |
|---|---|---|
| KW-6356Oral administration | Drug | KW-6356 Low Dose |
| KW-6356Oral administration | Drug | KW-6356 High Dose |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
Time frame: Up to 12 weeks after dosing
6 secondary outcomes
Clinical global impression-improvement(CGI-I) score
Time frame: Week 12
Patient global impression-improvement(PGI-I) score
Time frame: Week 12
Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores
Time frame: Up to 12 weeks after dosing
Number and percentage of subjects with treatment-emergent adverse events
Time frame: Up to 14 weeks after dosing
Profiles of pharmacokinetics of plasma KHK6356 concentration
Time frame: 2, 4, 8 and 12 weeks after dosing
Change from baseline in the MDS-UPDRS subitem and total scores
Time frame: Up to 12 weeks after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Derived from this study: PubMed 37948832Maeda T, Kimura T, Sugiyama K, Yamada K, Hiraiwa R, Nishi M, Hattori N; 6356-002 study group. Randomized controlled trial of KW-6356 monotherapy in patients with early untreated Parkinson's disease. Parkinsonism Relat Disord. 2023 Dec;117:105907. doi: 10.1016/j.parkreldis.2023.105907. Epub 2023 Oct 31.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KW-6356 in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 7 sites in Japan.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score (time frame: Up to 12 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02939391, which also lists 1 linked publication.
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 20 Mar 2018.