Parkinson's DiseasePhase 2NCT00610103
Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa Therapy
A Phase 2 study testing apomorphine hydrochloride in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy. 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?
- apomorphine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 4 sitesJapan
- Study dates
- Nov 2007to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 20 years or older at the time of giving informed consent.
- Patients who have idiopathic Parkinson's disease.
- Patients who have been on a stable regimen of levodopa (at least three times daily) plus at least one other antiparkinsonian agent being administered or more frequently for at least 30 days before the preliminary evaluation and who have predictable end-of-dose wearing-off.
- Patients who meet both of the following criteria on the Modified Hoehn and Yahr Scale during the preliminary evaluation and on the day before starting study drug (Day -1).
- Stage IV or V while in the OFF state
- Stage II to III while in the ON state
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- Patients who have experienced a 30% or more improvement in UPDRS Part 3 score when tested for responsiveness to levodopa during the baseline period.
- Patients who have at least one wearing-off episode per day and a daily average OFF time of at least two hours two days before starting study drug (Day -2) and on Day -1.
- Patients who can understand the OFF state or have a family member who can understand it.
- Patients who have given written informed consent. (Alternatively, the patient's legally acceptable representative may give written consent following the patient's oral consent, if his/her condition makes handwriting difficult.)
Who cannot join
- Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study.
- Patients with orthostatic hypotension.
- Patients with a history of drug allergies.
- 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 within five years before starting study drug.
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- Patients who have been taking domperidone at a dose level of more than 30 mg/day since before the preliminary evaluation.
- Patients who do not test negative in the direct Coombs' test as part of the preliminary evaluation.
- Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test during the preliminary evaluation or on Day -1, or women who cannot adhere to a reliable method of contraception throughout the study.
- Patients who have received MAO inhibitors except selegiline within three months before starting study drug.
- Patients with a current or past history of mental disease or dementia (excluding psychiatric symptoms associated with Parkinson's disease).
- Patients with a Mini-Mental State Examination (MMSE) score of 23 or less on or before Day -1.
- Patients who are taking antipsychotics or dopamine antagonists.
- Patients who are receiving methyldopa, 5-HT3 receptor antagonists, or reserpine.
- Patients who are receiving papaverine.
- Patients who have had a neurosurgical operation for Parkinson's disease.
- Patients who have had transcranial magnetic stimulation (TMS) within six months before starting study drug.
- Patients with a history of drug or alcohol abuse or dependence (DSM-IV criteria) within two years before starting study drug.
- Patients previously treated with apomorphine.
- Patients who have been treated with any other investigational product within four months before starting study drug.
- Patients who, for any reason, are judged by the investigator or subinvestigator to be inappropriate for this study.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Study site
Bunkyo-ku, Tokyo
Study site
Fukuoka
Study site
Tōon, Ehime
Study site
Tsukuba, Ibaraki
About this study
Official title: A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease
The purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy.
Read the detailed description
The efficacy of KW-6500 as a subcutaneous injection at the individualized maintenance dose level (1 mg to 6 mg per dose) when used in combination with domperidone (30 mg/day) will be evaluated in comparison with that of placebo in Parkinson's disease patients with motor response complications on levodopa therapy. The maintenance dose level for each subject will be determined using a titration scheme in 1 mg increments.
- Conditions
- Parkinson's Disease
- Being tested
- apomorphine hydrochloride
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apomorphine hydrochlorideDrug
Also called KW-6500
Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered.
| Study group | Role | What they receive |
|---|---|---|
| KW-6500 | Active comparator | Drug: KW-6500 (apomorphine hydrochloride (USAN)) Receives: Drug: apomorphine hydrochloride |
| Placebo | Placebo comparator | Placebo Receives: Drug: apomorphine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change (response ratio, raw score change, percent score change) in UPDRS (Unified Parkinson's Disease Rating Scale ) Part 3 score at the maintenance dose level
Measured: At 20 minutes after administering KW-6500 or placebo
Secondary outcomes (1)
The incidence of adverse events/adverse drug reactions and their nature
Measured: 1 week after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610103
- Sponsor's protocol ID
- 6500-0702
- Status last verified
- Aug 2020
- First submitted
- 22 Jan 2008
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00610103
- Acronym / sponsor ID
- 6500-0702
- Conditions
- Parkinson's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 Feb 2008 (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 purpose of this study is to evaluate the efficacy of KW-6500 versus placebo when administered as a subcutaneous injection at the individualized maintenance dose level in an OFF state in Parkinson's disease patients with motor response complications on levodopa therapy.
Detailed description
The efficacy of KW-6500 as a subcutaneous injection at the individualized maintenance dose level (1 mg to 6 mg per dose) when used in combination with domperidone (30 mg/day) will be evaluated in comparison with that of placebo in Parkinson's disease patients with motor response complications on levodopa therapy. The maintenance dose level for each subject will be determined using a titration scheme in 1 mg increments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KW-6500 | Active comparator | Drug: apomorphine hydrochlorideDrug: KW-6500 (apomorphine hydrochloride (USAN)) |
| Placebo | Placebo comparator | Drug: apomorphine hydrochloridePlacebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged 20 years or older at the time of giving informed consent.
- Patients who have idiopathic Parkinson's disease.
- Patients who have been on a stable regimen of levodopa (at least three times daily) plus at least one other antiparkinsonian agent being administered or more frequently for at least 30 days before the preliminary evaluation and who have predictable end-of-dose wearing-off.
- Patients who meet both of the following criteria on the Modified Hoehn and Yahr Scale during the preliminary evaluation and on the day before starting study drug (Day -1).
- Patients who have experienced a 30% or more improvement in UPDRS Part 3 score when tested for responsiveness to levodopa during the baseline period.
Key exclusion criteria (21 listed)
- Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study.
- Patients with orthostatic hypotension.
- Patients with a history of drug allergies.
- 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.
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 |
|---|---|---|
| apomorphine hydrochlorideAlso: KW-6500Apomorphine hydrochloride (started at 1 mg and titrated to a maximum of 6 mg) is subcutaneously administered. | Drug | KW-6500, Placebo |
Primary outcome
The change (response ratio, raw score change, percent score change) in UPDRS (Unified Parkinson's Disease Rating Scale ) Part 3 score at the maintenance dose level
Time frame: At 20 minutes after administering KW-6500 or placebo
1 secondary outcome
The incidence of adverse events/adverse drug reactions and their nature
Time frame: 1 week after starting treatment
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 28 Aug 2020.
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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.
Study Director study director
Kyowa Kirin Co., Ltd.
4 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 apomorphine hydrochloride in people with Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 4 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 10 inclusion and 21 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 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The change (response ratio, raw score change, percent score change) in UPDRS (Unified Parkinson's Disease Rating Scale ) Part 3 score at the maintenance dose level (time frame: At 20 minutes after administering KW-6500 or placebo). 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 28 Aug 2020.