Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Idiopathic Parkinson's Disease Clinical Trial

Official title:

A Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610231
• Other study ID #: 6002-018
• Status: Completed
• Phase: Phase 3
• Start date: December 2015
• Est. completion date: December 20, 2017

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 20, 2017
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

Drug:
• Istradefylline 20 mg or 40 mg
Istradefylline 20 or 40 mg

Locations

Country	Name	City	State
Canada	Kyowa PD Site	Calgary	Alberta
Canada	Kyowa PD Site	Toronto	Ontario
Czechia	Kwoya PD Site	Brno
Czechia	Kyowa PD Site	Litomysl
Czechia	Kyowa PD Site	Prague
Czechia	Kyowa PD Site	Praha
Germany	Kyowa PD Site	Beelitz-Heilstatten
Germany	Kyowa PD Site	Bremerhaven
Germany	Kyowa PD Site	Dresden
Germany	Kyowa PD Site	Haag
Germany	Kyowa PD Site	Kassel
Germany	Kyowa PD Site	Munchen
Israel	Kyowa PD Site	Haifa
Israel	Kyowa PD Site	Jerusalem
Israel	Kyowa PD Site	Ramat Gan
Israel	Kyowa PD Site	Tel Aviv
Italy	Kyowa PD Site	Grosseto
Italy	Kyowa PD Site	Pavia
Italy	Kyowa PD Site	Pisa
Italy	Kyowa PD Site	Roma
Italy	Kyowa PD Site	Rome
Italy	Kyowa PD Site	Venezia
Italy	Kyowa PD Site	Vicenza
Poland	Kyowa PD Site	Bydgoszcz
Poland	Kyowa PD Site	Krakow
Poland	Kyowa PD Site	Lublin
Poland	Kyowa PD Site	Poznan
Poland	Kyowa PD Site	Warszawa
Poland	Kyowa PD Site	Warszawa
Serbia	Kyowa PD Site 1	Belgrade
Serbia	Kyowa PD Site 4	Belgrade
Serbia	Kyowa PD Site	Novi Sad
United States	Kyowa PD Site	Albany	New York
United States	Kyowa PD Site	Asheville	North Carolina
United States	Kyowa PD Site	Atlanta	Georgia
United States	Kyowa PD Site	Augusta	Georgia
United States	Kyowa PD Site	Boca Raton	Florida
United States	Kyowa PD Site	Boston	Massachusetts
United States	Kyowa PD Site	Danbury	Connecticut
United States	Kyowa PD Site	Des Moines	Iowa
United States	Kyowa PD Site	Durham	North Carolina
United States	Kyowa PD Site	Englewood	Colorado
United States	Kyowa PD Site	Fountain Valley	California
United States	Kyowa PD Site	Kansas City	Kansas
United States	Kyowa PD Site	Los Angeles	California
United States	Kyowa PD Site	New York	New York
United States	Kyowa PD Site	Oxnard	California
United States	Kyowa PD Site	Phoenix	Arizona
United States	Kyowa PD Site	Port Charlotte	Florida
United States	Kyowa PD Site	Sun City	Arizona
United States	Kyowa PD Site	Tampa	Florida
United States	Kyowa PD Site	Toledo	Ohio
United States	Kyowa PD Site	Torrance	California
United States	Kyowa PD Site	Tucson	Arizona
United States	Kyowa PD Site	West Bloomfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.	Kyowa Hakko Kirin Pharma, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Israel,  Italy,  Poland,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Long-term Safety and Tolerability of Oral Istradefylline (20mg or 40mg/Day [mg/d])	The number of subjects experiencing an adverse event as well as clinical laboratory tests (chemistry, haematology and urinalysis) were collected to evaluate the safety profile of istradefylline (20mg or 40mg/day [mg/d]).	From screening through to study completion, an average of 52 weeks
Secondary	Patient Global Impression - Overall Condition (Improvement by Study Visit) (ITT Analysis Set).	The number and percentage of subjects showing improvement (moderate or mild) on PGI-I scores with Istradefylline 20 mg or 40 mg. Each subjects 'key symptom' (the symptom they had most trouble with) on the PGI-I was identified and evaluated at baseline and at Week 12, 26 and 52. In addition, the subject's overall condition and symptoms of fatigue, sleep and motivation to get things done were also evaluated at week 12, 26 and 52. Subjects rated each on a scale 1 to 5 for change from baseline status 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).	From baseline through to study completion at week 52, plus 30 days post last dose