Recruiting
Phase 3

AP-CD/LD

Sponsor:

Intec Pharma Ltd.

Code:

NCT02615873

Conditions

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Accordion Pill™ Carbidopa/Levodopa

Study Details

Brief summary:

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).

Conditions

Parkinson's Disease

Study ID

NCT02615873

Start date

Jul, 2016

Status verified date

Dec, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

460 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AP CD/LD

Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d

Interventions

Accordion Pill™ Carbidopa/Levodopa

Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d

Primary outcome measure

  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: base line ( week 1) to end of study ( week 53) ]

Central Contacts and Locations

Locations

University Alabama Hospital Neurology

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

University of Colorado Dept. of Neurology

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Hartford HealthCare

Recruiting

Vernon, Connecticut, United States, 06066

Contacts

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Parkinson's Disease and Movement Disorders Center

Recruiting

Tampa, Florida, United States, 33613

Contacts

Leigh Harrell

813-396-0768

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

The University of Kansas Hospital

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Boston University School of Medicine

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Marie-Helene Saint-Hilaire, MD

617-638-8456neuromsh@bu.edu

Michigan State University

Recruiting

East Lansing, Michigan, United States, 48824

Contacts

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Henry Ford Hospital

Recruiting

West Bloomfield, Michigan, United States, 48322

Contacts

Dartmouth Hitchcock Neurology

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

David L. Kreitzman, MD., PC

Recruiting

Commack, New York, United States, 11725

Contacts

David Kreitzman, MD

631-462-7774pdmdcli@aol.com

The Movement Disorder Clinic of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Thyagarajan Subramanian, MD

717-531-3828tsubram@yahoo.com

Vanderbilt University Medical Center Vanderbilt Clinical Neurosciences

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Baylor College of Medicine Department of Neurology

Recruiting

Houston, Texas, United States, 77030

Contacts

Joseph Jancovic, MD

713-798-6556josephj@bcm.edu

Booth Garner Parkinson's Care Center

Recruiting

Kirkland, Washington, United States, 98034

Contacts

More Information

Sponsor

Intec Pharma Ltd.

Last update posted

Aug 14, 2018

Last verified

Dec, 2017

Keywords

  • Parkinson's Disease
  • Fluctuating Parkinson's Disease
  • Carbidopa
  • Levodopa
  • Accordion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intec Pharma Ltd. on 2018-08-14.