Recruitment

Recruitment Status
Completed
Estimated Enrollment
609

Inclusion Criterias

PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
Documented end-of-dose wearing-off and levodopa-induced dyskinesia
Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
...
PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
Documented end-of-dose wearing-off and levodopa-induced dyskinesia
Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
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
UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
30 years of age or older.
On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
Have an average of two hours of OFF time per day

Exclusion Criterias

Subject who have had neurosurgical operation for PD
Subjects who smoke > 5 cigarettes/day
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
...
Subject who have had neurosurgical operation for PD
Subjects who smoke > 5 cigarettes/day
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers

Summary

Conditions
Idiopathic Parkinson's Disease
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 30 years and 125 years
Gender
Both males and females

Inclusion Criterias

PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
Documented end-of-dose wearing-off and levodopa-induced dyskinesia
Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
...
PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
Documented end-of-dose wearing-off and levodopa-induced dyskinesia
Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
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
UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
30 years of age or older.
On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
Have an average of two hours of OFF time per day

Exclusion Criterias

Subject who have had neurosurgical operation for PD
Subjects who smoke > 5 cigarettes/day
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
...
Subject who have had neurosurgical operation for PD
Subjects who smoke > 5 cigarettes/day
Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers

Locations

Warsaw, 01-697
Saint Louis, Missouri, 63110
Chicago, Illinois, 60612
Jerusalem, 91120
Grosseto, 58100
...
Warsaw, 01-697
Saint Louis, Missouri, 63110
Chicago, Illinois, 60612
Jerusalem, 91120
Grosseto, 58100
Bydgoszcz, 85-796
Fountain Valley, California, 92708
Haag, 83527
Philadelphia, Pennsylvania, 19107
Augusta, Georgia, 29841
Venezia, 30126
Beelitz-Heilstätten, 14547
Los Angeles, California, 90048
Berlin, 12203
Baltimore, Maryland, 21201
Reseda, California, 91335
Tubingen, 72076
Cassino, 03043
Irvine, California, 92697
Durham, North Carolina, 27705
Ramat Gan, 52621
Houston, Texas, 77030
Kingston, Ontario, K7L 2V7
Prague, 150 06
Asheville, North Carolina, 28806
Novi Sad, 21000
Tucson, Arizona, 85724
Kansas City, Kansas, 66160
Pisa, 56126
Prague, 140 00
Bremerhaven, 27574
Englewood, Colorado, 80113
New York, New York, 10016
Tampa, Florida, 33647
Brno, 656 91
Quebec City, Quebec, G1S 2L6
Krakow, 31-505
Gatineau, Quebec, J9J 0A5
Rome, 00133
Sunnyvale, California, 94085
Pasadena, California, 91105
Boca Raton, Florida, 33486
Prague, 12 000
New York, New York, 10032
Cleveland, Ohio, 44195
Tel Aviv, 64239
Calgary, Alberta, AB T2N
Danbury, Connecticut, 06810
Berlin, 13088
Haifa, 39106
Port Charlotte, Florida, 33980
Kielce, 25-103
Gottingen, 37075
Warsaw, 04-364
Chicago, Illinois, 60611
Munich, 80804
Cincinnati, Ohio, 45219
Oxnard, California, 93030
Jacksonville, Florida, 32209
Pavia, 27100
Phoenix, Arizona, 85004
Litomysl, 570 01
Boston, Massachusetts, 02215
Belgrade, 11000
Minneapolis, Minnesota, 55414
Des Moines, Iowa, 50309
Chieti, 66013
Torrance, California, 90505
Charleston, South Carolina, 29401
Toronto, Ontario, M5T 2S8
Belgrade, 11000
Belgrade, 11000
Ulm, 89081
Rome, 00163
Atlanta, Georgia, 30329
Dresden, 01307
Marburg, 35043
Petach Tiqva, 49372
Toledo, Ohio, 43614
West Bloomfield, Michigan, 48322
Albany, New York, 12208
Vicenza, 36057
Panama City, Florida, 32405
Sun City, Arizona, 85351
Dallas, Texas, 75390-9036
Olomouc, 775 20
Lublin, 20-093
Kassel, 34128
Poznan, 61-853

Tracking Information

NCT #
NCT01968031
Collaborators
Kyowa Kirin Co., Ltd.
Investigators
Study Chair: Kyowa Hakko Kirin Pharma, Inc. Kyowa Hakko Kirin Pharma, Inc.