Parkinson's DiseasePhase 36500-004NCT01058291
Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500
A Phase 3 study testing KW-6500 in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 1 site in Japan.
Trial summary
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- KW-6500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Oct 2010
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given written informed consent
- Patients who have Parkinson's disease
- Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
- Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
- Patients who have experienced a 30% or more improvement in Unified Parkinson's Disease Rating Scale (UPDRS) partⅢ score when tested for responsiveness to levodopa during the baseline period
- Patients who have at least one OFF state per day
- Patients who can understand the expression of OFF state, ON state, and dyskinesia
- Patients or their families have a desire for self-injection of KW-6500
Who cannot join
- Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
- Patients with orthostatic hypotension
- Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
- Patients with a history of malignant syndrome
- Patients with a diagnosis of cancer or evidence of continued disease
- Patients who do not test negative in the direct Coombs' test
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- Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
- Patients who have received MAO inhibitors except selegiline
- Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
- Patients with a Mini-Mental State Examination score of 23 or less
- Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
- Patients who are receiving methyldopa or 5-HT3 receptor antagonists
- Patients who are receiving reserpine or papaverine
- Patients who have had a neurosurgical operation for Parkinson's disease
- Patients who have had transcranial magnetic stimulation
- Patients with a history of drug or alcohol abuse or dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.
- Conditions
- Parkinson's Disease
- Being tested
- KW-6500, KW-6500 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-6500Drug
Also called Apomorphine hydroshloride (USAN)
Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state
KW-6500 PlaceboDrug
Twelve weeks subcutaneous injection for the OFF state
| Study group | Role | What they receive |
|---|---|---|
| KW-6500 | Experimental | Not described Receives: Drug: KW-6500 |
| KW-6500 Placebo | Placebo comparator | Not described Receives: Drug: KW-6500 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The raw score change in UPDRS part III score
Measured: At the double blind period
Secondary outcomes (1)
The percent score change in UPDRS part III score and response ratio
Measured: At the double blind period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2010
- Study completionOct 2010
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 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
- NCT01058291
- Sponsor's protocol ID
- 6500-004
- Acronym
- 6500-004
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 2010
- Last updated
- 3 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)
- ClinicalTrials.gov ID
- NCT01058291
- Acronym / sponsor ID
- 6500-004 / 6500-004
- Conditions
- Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Jan 2010 (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.
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KW-6500 | Experimental | Drug: KW-6500 |
| KW-6500 Placebo | Placebo comparator | Drug: KW-6500 Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who have given written informed consent
- Patients who have Parkinson's disease
- Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
- Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
- Patients who have experienced a 30% or more improvement in Unified Parkinson's Disease Rating Scale (UPDRS) partⅢ score when tested for responsiveness to levodopa during the baseline period
Key exclusion criteria (16 listed)
- Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
- Patients with orthostatic hypotension
- Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
- Patients with a history of malignant syndrome
- Patients with a diagnosis of cancer or evidence of continued disease
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-6500Also: Apomorphine hydroshloride (USAN)Twelve weeks subcutaneous injection of 1 to 6 mg for the OFF state | Drug | KW-6500 |
| KW-6500 PlaceboTwelve weeks subcutaneous injection for the OFF state | Drug | KW-6500 Placebo |
Primary outcome
The raw score change in UPDRS part III score
Time frame: At the double blind period
1 secondary outcome
The percent score change in UPDRS part III score and response ratio
Time frame: At the double blind period
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 3 Mar 2017.
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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.
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 3 study testing KW-6500 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 8 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: finished, as of the sponsor's last update on 3 Mar 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The raw score change in UPDRS part III score (time frame: At the double blind period). 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 3 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.