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Trial record 4 of 23 for:    istradefylline

A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)

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ClinicalTrials.gov Identifier: NCT01968031
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Kyowa Kirin, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )

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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: Istradefylline 40 mg Drug: Istradefylline 20 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Istradefylline 20 mg/day

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
Istradefylline 20 mg and placebo
Other Name: KW-6002

Drug: Placebo
Placebo

Experimental: Istradefylline 40 mg/day

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
Istradefylline 40 mg and placebo
Other Name: KW-6002

Drug: Placebo
Placebo

Placebo Comparator: Placebo

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
Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total Hours of ON Time Per Day Without Troublesome Dyskinesia [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
    Based on Patient's ON/OFF Diary

  2. Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III); [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
    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.

  3. 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. ]
    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.

  4. 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. ]
    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.

  5. Total UPDRS (Parts I + II + III); [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
    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.

  6. Patient Global Impression - Improvement (PGI-I) Scale [ Time Frame: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit ]

    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.


  7. Sleep Time in Hours Per Day Based Upon 24-hour Diaries. [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
  8. Percentage of Awake Time Per Day Spent in the OFF State [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
  9. Percentage of ON Time Per Day Without Troublesome Dyskinesia. [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ]
  10. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and Week 12. ]

    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.


  11. Beck Depression Inventory (BDI) [ Time Frame: Baseline and Week 12. ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968031


Locations
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Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Kirin Co., Ltd.
Investigators
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Study Chair: Kyowa Hakko Kirin Pharma, Inc. Kyowa Hakko Kirin Pharma, Inc.
Additional Information:
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Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01968031    
Other Study ID Numbers: 6002-014
2013-002254-70 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: November 20, 2020
Last Update Posted: November 20, 2020
Last Verified: September 2020
Keywords provided by Kyowa Kirin, Inc. ( Kyowa Hakko Kirin Pharma, Inc. ):
Parkinson's disease
Moderate to Severe Parkinson's Disease
Additional relevant MeSH terms:
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Istradefylline
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Adenosine A2 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs