Clinical trial NCT02610231: Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Official title: A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease
Moderate to Severe Parkinson's Disease
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Hakko Kirin Pharma, Inc.
First posted: 2015-11-20
Enrollment: 239
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, 52-week, open-label, flexible-dose, multinational, multicenter study to evaluate the safety and tolerability of istradefylline 20 or 40 mg/d in subjects with moderate to severe PD with motor fluctuations and dyskinesia on levodopa combination (levodopa/carbidopa or levodopa/benserazide) therapy plus at least one adjunctive PD medication. Subjects who completed 12 weeks of double-blind treatment and the 30-day follow-up period in Study No. 6002-014 will undergo Screening and Baseline evaluations for eligibility for the study. Eligible subjects will be treated with istradefylline at a starting dose of 20 mg/d with an option for a dose adjustment to 40 mg/d at Week 12 based on the Investigator's judgment of each subject's response and tolerability. If deemed necessary, one unscheduled dose adjustment visit between Week 2 to Week 12 is allowed in accordance with clinical judgment of the Investigator. Subjects who had a dose adjustment to 40 mg/d can have their dose decreased to 20 mg/d by the Investigator at a second unscheduled dose adjustment visit if there are tolerability issues. The istradefylline dose should remain fixed between Week 26 to Week 52. Consultation with the Sponsor's Medical Monitor is required prior to any unscheduled dose adjustment visits. A subject may discontinue from the study at any time.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent;
2. Subjects who completed Study No. 6002-014 inclusive of the 30-day follow-up period;
3. Currently taking levodopa combination (carbidopa/levodopa or benserazide/levodopa) therapy plus at least one adjunctive PD medication;
4. Women of child-bearing potential (WOCBP) must use a reliable method of contraception and have a negative serum pregnancy test at Screening;

Exclusion Criteria:

1. Subjects with less than 70% treatment compliance throughout their enrollment on Study No 6002-014 and or with major protocol deviations in Study No. 6002-014 (subjects who failed to meet any of the inclusion criteria, subjects who met any of the exclusion criteria or subjects who met the criteria for subject withdrawal but who were not withdrawn);
2. Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion;
3. Subject who have had neurosurgical operation for PD;
4. Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers;
5. Subjects who have had a diagnosis of cancer or evidence of continued malignancy within the past three years (with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).

Primary outcomes:
measure: Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])
timeFrame: From screening through to study completion, an average of 52 weeks
Secondary outcomes:
measure: Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).
timeFrame: From baseline through to study completion at week 52, plus 30 days post last dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Kyowa PD Site
state: Arizona
city: Sun City
country: United States
facility: Kyowa PD Site
state: Arizona
city: Tucson
country: United States
facility: Kyowa PD Site
state: Arizona
city: Fountain Valley
country: United States
facility: Kyowa PD Site
state: California
city: Los Angeles
country: United States
facility: Kyowa PD Site
state: California
city: Oxnard
country: United States
facility: Kyowa PD Site
state: California
city: Torrance
country: United States
facility: Kyowa PD Site
state: California
city: Englewood
country: United States
facility: Kyowa PD Site
state: Colorado
city: Danbury
country: United States
facility: Kyowa PD Site
state: Connecticut
city: Boca Raton
country: United States
facility: Kyowa PD Site
state: Florida
city: Port Charlotte
country: United States
facility: Kyowa PD Site
state: Florida
city: Tampa
country: United States
facility: Kyowa PD Site
state: Florida
city: Atlanta
country: United States
facility: Kyowa PD Site
state: Georgia
city: Augusta
country: United States
facility: Kyowa PD Site
state: Georgia
city: Des Moines
country: United States
facility: Kyowa PD Site
state: Iowa
city: Kansas City
country: United States
facility: Kyowa PD Site
state: Kansas
city: Boston
country: United States
facility: Kyowa PD Site
state: Massachusetts
city: West Bloomfield
country: United States
facility: Kyowa PD Site
state: Michigan
city: Albany
country: United States
facility: Kyowa PD Site
state: New York
city: New York
country: United States
facility: Kyowa PD Site
state: New York
city: Asheville
country: United States
facility: Kyowa PD Site
state: North Carolina
city: Durham
country: United States
facility: Kyowa PD Site
state: North Carolina
city: Toledo
country: United States
facility: Kyowa PD Site
state: Ohio
city: Calgary
country: Canada
facility: Kyowa PD Site
state: Alberta
city: Toronto
country: Canada
facility: Kyowa PD Site
state: Ontario
city: Brno
country: Czechia
facility: Kwoya PD Site
city: Litomysl
country: Czechia
facility: Kyowa PD Site
city: Prague
country: Czechia
facility: Kyowa PD Site
city: Praha
country: Czechia
facility: Kyowa PD Site
city: Beelitz-Heilstatten
country: Germany
facility: Kyowa PD Site
city: Bremerhaven
country: Germany
facility: Kyowa PD Site
city: Dresden
country: Germany
facility: Kyowa PD Site
city: Haag
country: Germany
facility: Kyowa PD Site
city: Kassel
country: Germany
facility: Kyowa PD Site
city: Munchen
country: Germany
facility: Kyowa PD Site
city: Haifa
country: Israel
facility: Kyowa PD Site
city: Jerusalem
country: Israel
facility: Kyowa PD Site
city: Ramat Gan
country: Israel
facility: Kyowa PD Site
city: Tel Aviv
country: Israel
facility: Kyowa PD Site
city: Grosseto
country: Italy
facility: Kyowa PD Site
city: Pavia
country: Italy
facility: Kyowa PD Site
city: Pisa
country: Italy
facility: Kyowa PD Site
city: Roma
country: Italy
facility: Kyowa PD Site
city: Rome
country: Italy
facility: Kyowa PD Site
city: Venezia
country: Italy
facility: Kyowa PD Site
city: Vicenza
country: Italy
facility: Kyowa PD Site
city: Bydgoszcz
country: Poland
facility: Kyowa PD Site
city: Krakow
country: Poland
facility: Kyowa PD Site
city: Lublin
country: Poland
facility: Kyowa PD Site
city: Poznan
country: Poland
facility: Kyowa PD Site
city: Warszawa
country: Poland
facility: Kyowa PD Site
city: Warszawa
country: Poland
facility: Kyowa PD Site
city: Belgrade
country: Serbia
facility: Kyowa PD Site 1
city: Belgrade
country: Serbia
facility: Kyowa PD Site 4
city: Novi Sad
country: Serbia
facility: Kyowa PD Site
Study officials:
affiliation: Kyowa Hakko Kirin Pharma, Inc.
name: Kyowa Hakko Kirin Pharma, Inc.
role: STUDY_DIRECTOR
References: