Idiopathic Parkinson's DiseasePhase 3KW-6002NCT01968031
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
A Phase 3 study testing Istradefylline 40 mg and Istradefylline 20 mg in people with Idiopathic Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 89 sites in 8 countries.
Trial summary
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Istradefylline 40 mg and Istradefylline 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 613 participants
- Where
- 89 sitesin 8 countries
- Study dates
- Oct 2013to Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 30 years of age or older.
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
- On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
- Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
- Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
- Documented end-of-dose wearing-off and levodopa-induced dyskinesia
- Have an average of two hours of OFF time per day
Who cannot join
- Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
- Subject who have had neurosurgical operation for PD
- Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
- Subjects who smoke > 5 cigarettes/day
Trial locations and contacts
89 sites in 8 countries.
89 sites in 8 countries
United States41 sites
Kyowa PD Site
Albany, New York, 12208
Kyowa PD Site
Asheville, North Carolina, 28806
Kyowa PD Site
Atlanta, Georgia, 30329
Kyowa PD Site
Augusta, Georgia, 29841
Kyowa PD Site
Baltimore, Maryland, 21201
Kyowa PD Site
Boca Raton, Florida, 33486
Kyowa PD Site
Boston, Massachusetts, 02215
Kyowa PD Site
Charleston, South Carolina, 29401
Kyowa PD Site
Chicago, Illinois, 60611
Kyowa PD Site
Chicago, Illinois, 60612
Kyowa PD Site
Cincinnati, Ohio, 45219
Kyowa PD Site
Cleveland, Ohio, 44195
Kyowa PD Site
Dallas, Texas, 75390-9036
Kyowa PD Site
Danbury, Connecticut, 06810
Kyowa PD Site
Des Moines, Iowa, 50309
Kyowa PD Site
Durham, North Carolina, 27705
Kyowa PD Site
Englewood, Colorado, 80113
Kyowa PD Site
Fountain Valley, California, 92708
Kyowa PD Site
Houston, Texas, 77030
Kyowa PD Site
Irvine, California, 92697
Kyowa PD Site
Jacksonville, Florida, 32209
Kyowa PD Site
Kansas City, Kansas, 66160
Kyowa PD Site
Los Angeles, California, 90048
Kyowa PD Site
Minneapolis, Minnesota, 55414
Kyowa PD Site
New York, New York, 10016
Kyowa PD Site
New York, New York, 10032
Kyowa PD Site
Oxnard, California, 93030
Kyowa PD Site
Panama City, Florida, 32405
Kyowa PD Site
Pasadena, California, 91105
Kyowa PD Site
Philadelphia, Pennsylvania, 19107
Kyowa PD Site
Phoenix, Arizona, 85004
Kyowa PD Site
Port Charlotte, Florida, 33980
Kyowa PD Site
Reseda, California, 91335
Kyowa PD Site
St Louis, Missouri, 63110
Kyowa PD Site
Sun City, Arizona, 85351
Kyowa PD Site
Sunnyvale, California, 94085
Kyowa PD Site
Tampa, Florida, 33647
Kyowa PD Site
Toledo, Ohio, 43614
Kyowa PD Site
Torrance, California, 90505
Kyowa PD Site
Tucson, Arizona, 85724
Kyowa PD Site
West Bloomfield, Michigan, 48322
Germany12 sites
Kyowa PD Site
Beelitz-Heilstätten, 14547
Kyowa PD Site
Berlin, 12203
Kyowa PD Site
Berlin, 13088
Kyowa PD Site
Bremerhaven, 27574
Kyowa PD Site
Dresden, 01307
Kyowa PD Site
Göttingen, 37075
Kyowa PD Site
Haag, 83527
Kyowa PD Site
Kassel, 34128
Kyowa PD Site
Marburg, 35043
Kyowa PD Site
Munich, 80804
Kyowa PD Site
Tübingen, 72076
Kyowa PD Site
Ulm, 89081
Italy9 sites
Kyowa PD Site
Cassino, 03043
Kyowa PD Site
Chieti, 66013
Kyowa PD Site
Grosseto, 58100
Kyowa PD Site
Pavia, 27100
Kyowa PD Site
Pisa, 56126
Kyowa PD Site
Rome, 00133
Kyowa PD Site
Rome, 00163
Kyowa PD Site
Venezia, 30126
Kyowa PD Site
Vicenza, 36057
Poland7 sites
Kyowa PD Site
Bydgoszcz, 85-796
Kyowa PD Site
Kielce, 25-103
Kyowa PD Site
Krakow, 31-505
Kyowa PD Site
Lublin, 20-093
Kyowa PD Site
Poznan, 61-853
Kyowa PD Site
Warsaw, 01-697
Kyowa PD Site
Warsaw, 04-364
Czechia6 sites
Kyowa PD Site
Brno, 656 91
Kyowa PD Site
Litomyšl, 570 01
Kyowa PD Site
Olomouc, 775 20
Kyowa PD Site
Prague, 12 000
Kyowa PD Site
Prague, 140 00
Kyowa PD Site
Prague, 150 06
Canada5 sites
Kyowa PD Site
Calgary, Alberta, AB T2N
Kyowa PD Site
Gatineau, Quebec, J9J 0A5
Kyowa PD Site
Kingston, Ontario, K7L 2V7
Kyowa PD Site
Québec, Quebec, G1S 2L6
Kyowa PD Site
Toronto, Ontario, M5T 2S8
Israel5 sites
Kyowa PD Site
Haifa, 39106
Kyowa PD Site
Jerusalem, 91120
Kyowa PD Site
Petach Tiqva, 49372
Kyowa PD Site
Ramat Gan, 52621
Kyowa PD Site
Tel Aviv, 64239
Serbia4 sites
Kyowa PD Site 1
Belgrade, 11000
Kyowa PD Site 2
Belgrade, 11000
Kyowa PD Site 4
Belgrade, 11000
Kyowa PD Site
Novi Sad, 21000
About this study
Official title: A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Istradefylline 40 mg, Istradefylline 20 mg, Placebo
- Keywords
- Parkinson's disease, Moderate to Severe Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istradefylline 40 mgDrug
Also called KW-6002
Istradefylline 40 mg and placebo
Istradefylline 20 mgDrug
Also called KW-6002
Istradefylline 20 mg and placebo
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Istradefylline 20 mg/day | Experimental | Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Receives: Drug: Istradefylline 20 mg; Drug: Placebo |
| Istradefylline 40 mg/day | Experimental | Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. Receives: Drug: Istradefylline 40 mg; Drug: Placebo |
| Placebo | Placebo comparator | Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. 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 Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Based on the 24-hour ON/OFF patient diary data.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Secondary outcomes (11)
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Based on Patient's ON/OFF Diary
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part III assesses the motor signs of Parkinson's Disease with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part III is 0 to 68. The lower the score, the more favorable the response.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part II is a self-evaluation of the activities of daily life (ADL) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part II is 0 to 52. The lower the score, the more favorable the response.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications. Part I is the evaluation of mentation, behavior, and mood with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The possible score range of Part I is 0 to 16. The lower the score, the more favorable the response.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Total UPDRS (Parts I + II + III);
The Unified Parkinson's Disease Rating Scale (UPDRS) evaluates various aspects of Parkinson's disease including non-motor and motor experiences of daily living and motor complications with a rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The total possible score range for all parts combined is 0 to 136. The lower the score, the more favorable the response.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Patient Global Impression - Improvement (PGI-I) Scale
The "key symptom" on the PGI-I was evaluated at baseline and subsequent post-baseline visits for the subject's overall condition and the symptoms of fatigue, sleep, motivation to get things done, and each subject's key symptom. Subjects rated each on a scale of 1 to 5 for change from baseline utilizing the following scale:
- 1 = Moderate improvement (or greater)
- 2 = Mild improvement
- 3 = No change from baseline
- 4 = Mild deterioration
- 5 = Moderate deterioration (or greater)
A lower number is a better outcome. Overall condition is presented below.
Measured: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of Awake Time Per Day Spent in the OFF State
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Measured: Baseline, Week 2, Week 6, Week 10 and Week 12.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) assesses different cognitive domains, broken down as follows:
Visuospatial and executive functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed recall (short-term memory): 5 points Orientation: 6 points
Scores can range from 0 to 30. A score of 26 or above is considered normal.
Measured: Baseline and Week 12.
Beck Depression Inventory (BDI)
The Beck Depression Inventory is a 21-question test that measures the severity of depression. Subjects rated each on a scale of 0 to 3 for change from baseline utilizing the following scale:
- 0 = I do not feel sad
- 1 = I feel sad
- 2 = I am sad all the time and I can't snap out of it
- 3 = I am so sad or unhappy that I can't stand it
The test is scored for each question using the above scale to determine the severity of depression. Scoring is as shown below:
- 0 to 9: minimal depression
- 10 to 18: mild depression
- 19 to 29: moderate depression
- 30 to 63: severe depression
Measured: Baseline and Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Responsible party
- Sponsor
- Investigators
- Kyowa Hakko Kirin Pharma, Inc., Study chair, Kyowa Hakko Kirin Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01968031
- Sponsor's protocol ID
- 6002-014
- Other IDs
- 2013-002254-70
- Acronym
- KW-6002
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2013
- Last updated
- 25 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01968031
- Acronym / sponsor ID
- KW-6002 / 6002-014
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Moderate to Severe Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyowa Hakko Kirin Pharma, Inc.
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Oct 2013 (estimated)
- Results
- Posted 20 Nov 2020
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 study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Istradefylline 20 mg/day | Experimental | Drug: Istradefylline 20 mg, Drug: PlaceboIstradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. |
| Istradefylline 40 mg/day | Experimental | Drug: Istradefylline 40 mg, Drug: PlaceboIstradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 30 years of age or older.
- UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
- On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
- Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
Key exclusion criteria (4 listed)
- Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
- Subject who have had neurosurgical operation for PD
- Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
- Subjects who smoke > 5 cigarettes/day
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 |
|---|---|---|
| Istradefylline 40 mgAlso: KW-6002Istradefylline 40 mg and placebo | Drug | Istradefylline 40 mg/day |
| Istradefylline 20 mgAlso: KW-6002Istradefylline 20 mg and placebo | Drug | Istradefylline 20 mg/day |
| PlaceboPlacebo | Drug | Istradefylline 20 mg/day, Istradefylline 40 mg/day, Placebo |
Primary outcome
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Based on the 24-hour ON/OFF patient diary data.
11 secondary outcomes
Total Hours of ON Time Per Day Without Troublesome Dyskinesia
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Total UPDRS (Parts I + II + III);
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Patient Global Impression - Improvement (PGI-I) Scale
Time frame: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit
Sleep Time in Hours Per Day Based Upon 24-hour Diaries.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of Awake Time Per Day Spent in the OFF State
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of ON Time Per Day Without Troublesome Dyskinesia.
Time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and Week 12.
Beck Depression Inventory (BDI)
Time frame: Baseline and Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Fox Trial Finder is a clinical trial matching tool that helps a Parkinson's patient connect with research sites. Volunteers who sign up will receive a list of trials in their area.Link provided by the sponsor.
Related trials for Idiopathic Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
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.
Kyowa Hakko Kirin Pharma, Inc. study chair
Kyowa Hakko Kirin Pharma, Inc.
89 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Istradefylline 40 mg and Istradefylline 20 mg in people with Idiopathic Parkinson's Disease, run by Kyowa Kirin Co., Ltd. at 89 sites in 8 countries.
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 4 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in United States, Germany, Italy, Poland, Czechia and 3 more countries. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Total Hours of Awake Time/Day Spent in the OFF State at Week 12 (time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.). 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 25 Apr 2024.