A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations

A Phase 2 study testing KW-6356 in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to determine the recommended dose and evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partIII score between KW-6356 and… 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: 502 participants
Where: 1 siteJapan
Study dates: 29 Sep 2018to 15 Apr 2020
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 2 to 4 on the Modified Hoehn and Yahr Scale. (mH\&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
MDS-UPDRS partIII score of >= 15. (Evaluation at ON state)
Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Who cannot join

Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
Subject who have received administration of adenosine A2A receptor antagonist.
Either of the following criteria consecutively at screening and enrollment; Resting Pulse > 100 bpm Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg

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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 subinvestigator including those who are unable to communicate or to cooperate with the investigator or subinvestigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Iwamizawa Neurology Clinic
Iwamizawa, Hokkaido

Other trials in Japan

About this study

Official title: A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations

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
PlaceboDrug
Oral administration

Study groups in NCT03703570
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) part III score
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).
Measured: Up to 26 weeks after dosing

Secondary outcomes (1)

Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)
Measured: Up to 26 weeks after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 201815 Apr 2020

First posted12 Oct 2018
Study start29 Sep 2018
Primary completion15 Apr 2020
Study completion15 Apr 2020

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.
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
Model description: An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 502 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03703570
Sponsor's protocol ID: 6356-003
Status last verified: Sep 2020
First submitted: 5 Oct 2018
Last updated: 7 Sep 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing Preparations
ClinicalTrials.gov ID: NCT03703570
Acronym / sponsor ID: 6356-003
Conditions: Parkinson's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 502 participants (actual)
Lead sponsor: Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Sep 2018 (actual)
Primary completion: 15 Apr 2020 (actual)
Study completion: 15 Apr 2020 (actual)
First posted: 12 Oct 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: An interventional, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial

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 (5 listed)

Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria.
Parkinson's disease patients in Stages 2 to 4 on the Modified Hoehn and Yahr Scale. (mH\&Y, Evaluation at ON state for patients who experience Wearing-off phenomenon)
MDS-UPDRS partIII score of >= 15. (Evaluation at ON state)
Subject who are responsive to levodopa/DCI (carbidopa or benserazide) combination therapy and who have been on the therapy for 6 months or longer without interruption at enrollment.
Subject who have not started any new antiparkinsonian drugs and have been on a stable regimen of antiparkinsonian drugs in the 3 months before enrollment.

Key exclusion criteria (9 listed)

Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
Use of any of the following drugs within 3 months (or 6 month in case of depot preparations) prior to enrollment; Antipsychotics, tiapride, metoclopramide, amoxapine, reserpine, tetrabenazine, methyldopa, papaverine, Levodopa/carbidopa intestinal gel and apomorphine hydrochloride injection
Treatment by transcranial magnetic stimulation (TMS) within 6 months prior to enrollment.
Neurosurgical operation for Parkinson's disease. (stereotactic surgery, deep brain stimulation or gamma knife)
Subject who have received administration of adenosine A2A receptor antagonist.

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 High Dose, KW-6356 Low Dose
PlaceboOral administration	Drug	placebo

Primary outcome

Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) part III score
Time frame: Up to 26 weeks after dosing
MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) nonmotor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total score is the sum of the subscale scores for Parts III and ranges from 0 (no disability) to 136 (total dependence).

1 secondary outcome

Change from baseline in the total hours of awake time per day spent in the OFF state. (total hours per day spent in the OFF state)
Time frame: Up to 26 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 7 Sep 2020.

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.

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 KW-6356 in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site 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 5 inclusion and 9 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 7 Sep 2020. 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 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) part III score (time frame: Up to 26 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 NCT03703570.

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 7 Sep 2020.