A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004

Status unconfirmed · Phase 3

Conditions studied: Parkinson's Disease

In brief

The purpose of this study is to allow evaluation of long-term clinical effect and safety outcome of treatment with AP-CD/LD, as well as to allow patients to benefit from extended treatment duration with AP-CD/LD after they have successfully completed the Phase 3 core study IN 11 004 ('core study', a phase III, multicenter, randomized, double-blind, double-dummy, active-controlled Phase 3 study to assess the safety and efficacy of AP CD/LD versus IR CD/LD in fluctuating PD patients).

Key facts

Study ID

NCT02615873

Run by

Intec Pharma Ltd.

People needed

460

Starts

2016-07-01

Expected to finish

2019-12-01

Last updated by the study team

2018-08-14

Who can join

Age: 30 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Continue to carry the diagnosis of Parkinson's disease consistent with UK brain bank criteria
• Has a good response to Levodopa in the opinion of the investigator
• Subjects able and willing to give written (signed and dated) informed consent to participate in the study

You may not qualify if…

• 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
• Previous or planned neurosurgical or Duodopa treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation)
• Non-selective monoamine oxidase (MAO) inhibitors within 28 days prior to Baseline Visit or planned administration during study participation
• If, in the opinion of the Investigator, subject should not participate in the study
• Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception.

Where it is running

• Baylor College of Medicine Department of Neurology — Houston, Texas, United States (enrolling)
• TASMC — Tel Aviv, Israel (enrolling)
• The Movement Disorder Clinic of Oklahoma — Tulsa, Oklahoma, United States (enrolling)
• Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences — Nashville, Tennessee, United States (enrolling)
• Chaim Sheba Medical Center at Tel Hashomer — Ramat Gan, Israel (enrolling)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)
• University Alabama Hospital Neurology — Birmingham, Alabama, United States (enrolling)
• University of Colorado Dept. of Neurology — Aurora, Colorado, United States (enrolling)
• Hartford HealthCare — Vernon, Connecticut, United States (enrolling)
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• Rambam Medical Center — Haifa, Israel (enrolling)
• Rabin Medical Center — Petah Tikva, Israel (enrolling)
• Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• The University of Kansas Hospital — Kansas City, Kansas, United States (enrolling)
• Boston University School of Medicine — Boston, Massachusetts, United States (enrolling)
• Michigan State University — East Lansing, Michigan, United States (enrolling)
• Quest Research Institute — Farmington Hills, Michigan, United States (enrolling)
• Henry Ford Hospital — West Bloomfield, Michigan, United States (enrolling)
• Dartmouth Hitchcock Neurology — Lebanon, New Hampshire, United States (enrolling)
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (enrolling)
• David L. Kreitzman, MD., PC — Commack, New York, United States (enrolling)
• Booth Garner Parkinson's Care Center — Kirkland, Washington, United States (enrolling)
• Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease — Haifa, Israel (enrolling)
• Centrum Medyczne Damiana Holding — Warsaw, Poland (enrolling)

Full record on ClinicalTrials.gov

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