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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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24 April 2023 |
Main ID: |
NCT02579473 |
Date of registration:
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13/10/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214
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Scientific title:
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A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose Titration |
Date of first enrolment:
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January 2016 |
Target sample size:
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20 |
Recruitment status: |
Active, not recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02579473 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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David G Standaert, MD, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Univeristy of Alabama-Birmingham School of Medicine, Division of Neurology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Female or male subjects 40-80 years of age inclusive
2. A diagnosis of idiopathic Parkinson's disease (PD) consistent with UK brain bank
criteria
3. De novo PD patients and those on a stable regimen of anti-Parkinson's drugs for at
least 4weeks prior to screening including anticholingerics, amantadine, MAO-B
inhibitors, COMT inhibitors or levodopa, but not dopamine agonists
4. Free of clinically significant motor complications as determined by the investigator
5. Ability to complete up to four weeks of dosing once per week with two weeks of
terminal "wash-out" PK
6. Ability to return to the clinic for blood sampling, clinical and laboratory assessment
on scheduled days, based upon cohort
7. Mini Mental State Exam (MMSE) > 26
8. Women of child-bearing potential (WOCBP) must use a reliable method of contraception
(e.g., oral contraceptive or long-term injectable or implantable hormonal
contraceptive, double-barrier methods [such as condom plus diaphragm, condom plus
spermicidal foam, condom plus sponge], or intra-uterine devices), and must have a
negative serum pregnancy test at Screening and negative urine pregnancy test at
baseline
9. Willing and able to comply with the study requirements including follow-up
10. Provide written informed consent
11. Cognitively intact sufficient to understand and provide informed consent
12. Approved by a central Eligibility Monitoring Committee (EMC) confirmed by EMC
signature on the Enrollment Authorization Form (EAF)
Exclusion Criteria:
1. Subject has previously participated in this study.
2. Myocardial infarction within the past six months from screening
3. Ischemic stroke or transient ischemic event within the past two years from screening
4. Known sensitivity to dopamine agonists including nausea/vomiting, orthostatic
hypotension, excessive sleep or impulse control disorder
5. Any major organ disease that substantially impairs life expectancy
6. History of cancer, other than basal cell carcinoma, within the past 10 years or
subjects with any laboratory or physical exam or diagnostic procedure finding
suggestive of current malignancy
7. Subjects who are known to be immunosuppressed or are receiving chronic treatment with
immunosuppressive drugs
8. Subject with an atypical or secondary Parkinsonian (e.g., due to drugs, metabolic
neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease)
9. Any clinically significant medical, surgical, or psychiatric condition, laboratory
value, or concomitant medication which, in the opinion of the Investigator, makes the
subject unsuitable for study entry or potentially unable to complete all aspects of
the study.
10. Subject has moderate renal impairment (creatine > 2.5)
11. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh
categorization C, score 10-15) hepatic impairment.
12. Subject has a lifetime history of suicide attempt (including an active attempt,
interrupted attempt or aborted attempt), or has suicidal ideation in the past 6 months
as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the
Columbia-Suicide Severity Rating Scale (CSSRS) at Screening
13. Subject has known hypersensitivity to rotigotine or to any components or excipients of
the study drug
14. Subject has a history of psychosis or hallucinations within the previous 12 months
15. Subject has received an investigational drug within 30 days of screening or is
currently participating in an investigational drug or investigational device trial
16. Subject, who, for any reason, is judged by the Investigator to be inappropriate for
this study, including a subject who is unable to communicate or cooperate with the
Investigator or who has/had a clinically significant illness or abnormal physical
examination that may compromise safety of the subject during the trial or affect
ability of the subject to adhere to study procedures
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Drug: SER-214
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Primary Outcome(s)
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Safety - ECG Changes
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Safety - Treatment-Emergent Adverse Events
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Safety - Vital Signs
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Safety - Abnormal Laboratory Results
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability}
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Safety - Adverse Events and Serious Adverse Events
[Time Frame: From initial sc dose of SER-214 up to six weeks of follow-up]
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Secondary Outcome(s)
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Unified Parkinson's Disease Rating Scale
[Time Frame: From Screening up to six weeks of follow-up]
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Unified Parkinson's Disease Rating Scale - Motor Part III Only
[Time Frame: From Screening up to six weeks of follow-up]
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Dose-adjusted area under the curve (AUC)
[Time Frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours]
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Epworth Sleepiness Scale (ESS)
[Time Frame: From Screening up to six weeks of follow-up]
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Maximum plasma concentration [C(max)]
[Time Frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours]
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Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease (QUIP)
[Time Frame: From screening up to six weeks of follow-up]
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Columbia Suicide Severity Rating Scale (C-SSRS)
[Time Frame: From Screening up to six weeks of follow-up]
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Time to maximum concentration [T(max)]
[Time Frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours]
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Fluctuation index
[Time Frame: On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours]
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Secondary ID(s)
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SER-214 Ia
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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