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

Phase 3

• Conditions: Parkinson's Disease
• Interventions: Drug: Accordion Pill™ Carbidopa/Levodopa

• Registration Number: NCT02615873
• Lead Sponsor: Intec Pharma Ltd.

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).

Detailed Description

This will be a multi-center, global, open-label study in adult suffering from fluctuating Parkinson's disease subjects who have successfully completed the core study IN 11 004.

After signing informed consent and meeting inclusion/exclusion criteria, eligible subjects will be enrolled into a 12-month open-label extension and receive the AP-CD/LD as needed.

Efficacy and safety will be assessed throughout the study period.

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-11-26
• Study Start: 2016-07
• Status Verified: 2017-12
• Last Update Submitted: 2018-08-12
• Last Update Posted: 2018-08-14
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AP CD/LD	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 Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS)	base line ( week 1) to end of study ( week 53)	Change from Baseline to End of Study (Week 53) in Parts I-IV

Secondary Outcome Measures

Name	Time	Method
Safety (Adverse Events, Safety laboratory, Vital signs)	One Year	Adverse Events, Safety laboratory, Vital signs
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).	Base line to end of study ( week 53)	Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).

Trial Locations

Locations (84)

University Alabama Hospital Neurology; 🇺🇸 Birmingham, Alabama, United States

Saint Joseph's Hospital and Medical Center Muhammad Ali Parkinson Research Center; 🇺🇸 Phoenix, Arizona, United States

Banner Sun Health Research Institute; 🇺🇸 Sun City, Arizona, United States

Parkinson's Disease & Movement Disorders Center; 🇺🇸 Fountain Valley, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

SC3 Research; 🇺🇸 Reseda, California, United States

University of Colorado Dept. of Neurology; 🇺🇸 Aurora, Colorado, United States

Hartford HealthCare; 🇺🇸 Vernon, Connecticut, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

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