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Completed

NCT Number: NCT01968031

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

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.

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Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kyowa PD Site, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Istradefylline 40 mg

Drug

Istradefylline 40 mg and placebo

Other names: KW-6002

Istradefylline 20 mg

Drug

Istradefylline 20 mg and placebo

Other names: KW-6002

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Collaborators

  • Kyowa Hakko Kirin Pharma, Inc.

Registry information

Official study 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

Acronym: KW-6002

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2013
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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