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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT03881371 |
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Date of registration:
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18/03/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa
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Scientific title:
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A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of Levodopa |
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Date of first enrolment:
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August 1, 2019 |
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Target sample size:
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307 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03881371 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Male or female patients aged =18 years old.
2. Chinese ethnicity.
3. Able to understand and willing to provide written informed consent.
4. Able to maintain an accurate and complete 24-hour diary with the help of a caregiver.
5. Diagnosis of idiopathic Parkinson's Disease (IPD) using the United Kingdom Parkinson's
Disease Society Brain Bank criteria of more than 3 years duration.
6. Be levodopa responsive and receiving treatment with stable daily doses of oral L-dopa,
with or without benserazide/carbidopa, with or without addition of a
catechol-O-methyltransferase (COMT) inhibitor and may be receiving concomitant
treatment with stable doses of dopamine agonists, anticholinergics and/or amantadine
for at least 4 weeks prior to the screening visit.
7. A Hoehn and Yahr stage between 1-4 inclusive during the "ON" phase.
8. Experiencing motor fluctuations with a minimum of 1.5 hours/day of "OFF" time during
the day (excluding morning akinesia), based on historical data.
9. If female, be post-menopausal for at least one year or have undergone hysterectomy or,
if of child-bearing potential, must have a negative pregnancy test, must not be
breast-feeding nor become pregnant during the study and must use adequate
contraception for 1 month prior to randomisation and for up to 1 month after the last
dose of study drug. Adequate contraception is defined as:
1. Hormonal oral, implantable, transdermal, or injectable contraceptives or a
non-hormonal intrauterine device or female condom with spermicide or
contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap
with spermicide for at least 2 months before the screening visit;
2. a male sexual partner who agrees to use a male condom with spermicide or a
sterile sexual partner . For all women of child-bearing potential, urine
pregnancy test result at screening must be negative.
For all women of child-bearing potential, urine pregnancy test result at screening must be
negative.
Exclusion Criteria:
1. Any form of Parkinsonism other than IPD.
2. Diagnosis of chronic migraine (>15 days per month) or cancer pain.
3. L-dopa infusion.
4. Hoehn and Yahr stage 5 during the "ON" phase.
5. If female, pregnancy or breast-feeding.
6. Neurosurgical intervention of PD or stereotactic brain surgery.
7. Severe peak dose or biphasic dyskinesia, unpredictable or widely swinging
fluctuations.
8. History of major depression or other clinically significant psychotic disorder which
compromise the ability to provide the informed consent or to participate to the study.
9. Drug and/or alcohol abuse within 12 months prior to the screening visit.
10. History of dementia or severe cognitive dysfunction.
11. Use of any investigational drug or device within 30 days prior to screening or 5
half-lives, whichever is the longest, or during the study.
12. Allergy/sensitivity or contraindications to the investigational medicinal products
(IMPs) or their excipients, to anticonvulsants or to anti-Parkinson drugs.
13. Any clinically significant condition (including laboratory values) which, in the
opinion of the Investigator, would not be compatible with study participation or
represent a risk for patients while in the study.
14. Moderate or severe liver failure using the Child-Pugh classification score, or human
immunodeficiency virus (HIV) infection.
15. Treatment with monoamine oxidase inhibitors (MAOIs), pethidine, opiates, opioids,
fluoxetine, fluvoxamine in the 4 weeks prior to the screening visit. These drugs are
not allowed throughout the study and up 2 weeks after the last dose of study drug.
16. Ophthalmologic history including any of the following conditions: albinism, uveitis,
retinitis pigmentosa, retinal degeneration, active retinopathy, severe progressive
diabetic retinopathy, inherited retinopathy or family history of hereditary retinal
disease.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Other: Placebo
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Drug: Safinamide
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Primary Outcome(s)
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Change From Baseline to Week 16 in the Mean Total Daily "OFF" Time
[Time Frame: At baseline and Week 16]
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Secondary Outcome(s)
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Change From Baseline to Week 16 in the UPDRS Part II Activities of Daily Living (ADL) Score During the "ON" Phase
[Time Frame: At baseline and Week 16]
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Change From Baseline to Week 16 in Pain Severity, as Assessed by an 11 Point Numerical Rating Scale (NRS)
[Time Frame: At baseline and Week 16]
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Change From Baseline to Week 16 in the UPDRS Part III (Motor Function) Score During the "ON" Phase
[Time Frame: At baseline and Week 16]
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Clinical Global Impression of Severity (CGI-S) Score Assessed at Week 16
[Time Frame: At week 16]
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Change From Baseline to Week 16 in the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Score
[Time Frame: At baseline and Week 16]
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Clinical Global Impression of Change (CGI-C) Assessed at Week 16
[Time Frame: At baseline and Week 16]
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Change From Baseline to Week 16 in the Mean Daily "ON" Time With no/Non Troublesome Dyskinesia
[Time Frame: At baseline and Week 16]
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Change From Baseline to Week 16 in the Mean Total Daily "ON" Time
[Time Frame: At baseline and Week 16]
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Change From Baseline to Week 16 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score During the "ON" Phase
[Time Frame: At baseline and Week 16]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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