A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

NCT01968031 | Completed Phase 3 Results

• 2 other identifiers: 6002-0142013-002254-70
• Study Type: interventional
• Target: 613
• Locations: 8 countries
• Sites: 89

Brief 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 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

Keywords

Parkinson's disease; Moderate to Severe Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 2, Week 6, Week 10 and Week 12.

Secondary Outcomes (11)

• Total Hours of ON Time Per Day Without Troublesome Dyskinesia

  Baseline, Week 2, Week 6, Week 10 and Week 12.

• Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);

  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)

  Baseline, Week 2, Week 6, Week 10 and Week 12.

• Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)

  Baseline, Week 2, Week 6, Week 10 and Week 12.

• Total UPDRS (Parts I + II + III);

  Baseline, Week 2, Week 6, Week 10 and Week 12.

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

Istradefylline 40 mg DRUG

Istradefylline 40 mg and placebo

Also known as: KW-6002

Istradefylline 40 mg/day

Istradefylline 20 mg DRUG

Istradefylline 20 mg and placebo

Also known as: KW-6002

Istradefylline 20 mg/day

Placebo DRUG

Placebo

Istradefylline 20 mg/day; Istradefylline 40 mg/day; Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead
• Kyowa Hakko Kirin Pharma, Inc.: collaborator

Study Sites (89)

Kyowa PD Site

Phoenix, Arizona, 85004, United States

Location

Kyowa PD Site

Sun City, Arizona, 85351, United States

Location

Kyowa PD Site

Tucson, Arizona, 85724, United States

Location

Kyowa PD Site

Fountain Valley, California, 92708, United States

Location

Kyowa PD Site

Irvine, California, 92697, United States

Location

Kyowa PD Site

Los Angeles, California, 90048, United States

Location

Kyowa PD Site

Oxnard, California, 93030, United States

Location

Kyowa PD Site

Pasadena, California, 91105, United States

Location

Kyowa PD Site

Reseda, California, 91335, United States

Location

Kyowa PD Site

Sunnyvale, California, 94085, United States

Location

Kyowa PD Site

Torrance, California, 90505, United States

Location

Kyowa PD Site

Englewood, Colorado, 80113, United States

Location

Kyowa PD Site

Danbury, Connecticut, 06810, United States

Location

Kyowa PD Site

Boca Raton, Florida, 33486, United States

Location

Kyowa PD Site

Jacksonville, Florida, 32209, United States

Location

Kyowa PD Site

Panama City, Florida, 32405, United States

Location

Kyowa PD Site

Port Charlotte, Florida, 33980, United States

Location

Kyowa PD Site

Tampa, Florida, 33647, United States

Location

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Atlanta, Georgia, 30329, United States

Location

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Augusta, Georgia, 29841, United States

Location

Kyowa PD Site

Chicago, Illinois, 60611, United States

Location

Kyowa PD Site

Chicago, Illinois, 60612, United States

Location

Kyowa PD Site

Des Moines, Iowa, 50309, United States

Location

Kyowa PD Site

Kansas City, Kansas, 66160, United States

Location

Kyowa PD Site

Baltimore, Maryland, 21201, United States

Location

Kyowa PD Site

Boston, Massachusetts, 02215, United States

Location

Kyowa PD Site

West Bloomfield, Michigan, 48322, United States

Location

Kyowa PD Site

Minneapolis, Minnesota, 55414, United States

Location

Kyowa PD Site

St Louis, Missouri, 63110, United States

Location

Kyowa PD Site

Albany, New York, 12208, United States

Location

Kyowa PD Site

New York, New York, 10016, United States

Location

Kyowa PD Site

New York, New York, 10032, United States

Location

Kyowa PD Site

Asheville, North Carolina, 28806, United States

Location

Kyowa PD Site

Durham, North Carolina, 27705, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

Kyowa PD Site

Cleveland, Ohio, 44195, United States

Location

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Toledo, Ohio, 43614, United States

Location

Kyowa PD Site

Philadelphia, Pennsylvania, 19107, United States

Location

Kyowa PD Site

Charleston, South Carolina, 29401, United States

Location

Kyowa PD Site

Dallas, Texas, 75390-9036, United States

Location

Kyowa PD Site

Houston, Texas, 77030, United States

Location

Kyowa PD Site

Calgary, Alberta, AB T2N, Canada

Location

Kyowa PD Site

Kingston, Ontario, K7L 2V7, Canada

Location

Kyowa PD Site

Toronto, Ontario, M5T 2S8, Canada

Location

Kyowa PD Site

Gatineau, Quebec, J9J 0A5, Canada

Location

Kyowa PD Site

Québec, Quebec, G1S 2L6, Canada

Location

Kyowa PD Site

Brno, 656 91, Czechia

Location

Kyowa PD Site

Litomyšl, 570 01, Czechia

Location

Kyowa PD Site

Olomouc, 775 20, Czechia

Location

Kyowa PD Site

Prague, 12 000, Czechia

Location

Kyowa PD Site

Prague, 140 00, Czechia

Location

Kyowa PD Site

Prague, 150 06, Czechia

Location

Kyowa PD Site

Beelitz-Heilstätten, 14547, Germany

Location

Kyowa PD Site

Berlin, 12203, Germany

Location

Kyowa PD Site

Berlin, 13088, Germany

Location

Kyowa PD Site

Bremerhaven, 27574, Germany

Location

Kyowa PD Site

Dresden, 01307, Germany

Location

Kyowa PD Site

Göttingen, 37075, Germany

Location

Kyowa PD Site

Haag, 83527, Germany

Location

Kyowa PD Site

Kassel, 34128, Germany

Location

Kyowa PD Site

Marburg, 35043, Germany

Location

Kyowa PD Site

Munich, 80804, Germany

Location

Kyowa PD Site

Tübingen, 72076, Germany

Location

Kyowa PD Site

Ulm, 89081, Germany

Location

Kyowa PD Site

Haifa, 39106, Israel

Location

Kyowa PD Site

Jerusalem, 91120, Israel

Location

Kyowa PD Site

Petach Tiqva, 49372, Israel

Location

Kyowa PD Site

Ramat Gan, 52621, Israel

Location

Kyowa PD Site

Tel Aviv, 64239, Israel

Location

Kyowa PD Site

Cassino, 03043, Italy

Location

Kyowa PD Site

Chieti, 66013, Italy

Location

Kyowa PD Site

Grosseto, 58100, Italy

Location

Kyowa PD Site

Pavia, 27100, Italy

Location

Kyowa PD Site

Pisa, 56126, Italy

Location

Kyowa PD Site

Rome, 00133, Italy

Location

Kyowa PD Site

Rome, 00163, Italy

Location

Kyowa PD Site

Venezia, 30126, Italy

Location

Kyowa PD Site

Vicenza, 36057, Italy

Location

Kyowa PD Site

Bydgoszcz, 85-796, Poland

Location

Kyowa PD Site

Kielce, 25-103, Poland

Location

Kyowa PD Site

Krakow, 31-505, Poland

Location

Kyowa PD Site

Lublin, 20-093, Poland

Location

Kyowa PD Site

Poznan, 61-853, Poland

Location

Kyowa PD Site

Warsaw, 01-697, Poland

Location

Kyowa PD Site

Warsaw, 04-364, Poland

Location

Kyowa PD Site 1

Belgrade, 11000, Serbia

Location

Kyowa PD Site 2

Belgrade, 11000, Serbia

Location

Kyowa PD Site 4

Belgrade, 11000, Serbia

Location

Kyowa PD Site

Novi Sad, 21000, Serbia

Location

Related Links

• 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.

MeSH Terms

Conditions

Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Kyowa Kirin Pharmaceutical Development
• Organization: Kyowa Kirin Pharmaceutical Development

kkd.clintrial.82@kyowakirin.com

609-919-1100

Study Officials

• Kyowa Hakko Kirin Pharma, Inc.

  Kyowa Hakko Kirin Pharma, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 25, 2024
• Results First Posted: November 20, 2020

Record last verified: 2024-04

Locations

IL (5); CA (5); IT (9); DE (12); US (41); SE (4); PL (7); CZ (6)