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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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12 December 2020 |
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Main ID: |
NCT02615873 |
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Date of registration:
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23/11/2015 |
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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 of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004
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Scientific title:
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An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004 |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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460 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02615873 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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Germany
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Israel
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Italy
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Poland
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Slovakia
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Peter LeWitt, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Henry Ford Hospital - West Bloomfield |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects who successfully completed the core study IN 11 004 and, in the opinion of
the Investigator, would benefit from long-term treatment with AP-CD/LD
2. Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank
criteria
3. Has a good response to Levodopa in the opinion of the investigator
4. Subjects able and willing to give written (signed and dated) informed consent to
participate in the study
Exclusion Criteria:
1. Participation in another clinical trial other than IN 11 004 and receipt of an
investigational medication other than that administered in the context of IN 11 004
within 28 days prior to the planned start of treatment
2. Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g.,
procedures including ablation or deep brain stimulation)
3. Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline
Visit or planned administration during study participation
4. If, in the opinion of the Investigator, subject should not participate in the study
5. Women who are pregnant or nursing. Women of childbearing potential who are not willing
to use a medically acceptable method of contraception.
Age minimum:
30 Years
Age maximum:
100 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: Accordion Pill™ Carbidopa/Levodopa
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Primary Outcome(s)
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Unified Parkinson's Disease Rating Scale (UPDRS)
[Time Frame: base line ( week 1) to end of study ( week 53)]
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Secondary Outcome(s)
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Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
[Time Frame: Base line to end of study ( week 53)]
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Safety (Adverse Events, Safety laboratory, Vital signs)
[Time Frame: One Year]
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Secondary ID(s)
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IN 11 004 OLE
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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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