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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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ClinicalTrials.gov Identifier: NCT02615873
Recruitment Status : Recruiting
First Posted : November 26, 2015
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Accordion Pill™ Carbidopa/Levodopa Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: 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
Other Name: AP CD/LD




Primary Outcome Measures :
  1. Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 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 :
  1. Safety (Adverse Events, Safety laboratory, Vital signs) [ Time Frame: One Year ]
    Adverse Events, Safety laboratory, Vital signs

  2. Change in Parkinson's disease Questionnaire - 39 items (PDQ39). [ Time Frame: Base line to end of study ( week 53) ]
    Change from baseline to End of Study in Parkinson's disease Questionnaire - 39 items (PDQ39).



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02615873


  Show 85 Study Locations
Sponsors and Collaborators
Intec Pharma Ltd.
Investigators
Principal Investigator: Peter LeWitt, MD Henry Ford Hospital - West Bloomfield

Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02615873     History of Changes
Other Study ID Numbers: IN 11 004 OLE
First Posted: November 26, 2015    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: December 2017

Keywords provided by Intec Pharma Ltd.:
Parkinson's Disease
Fluctuating Parkinson's Disease
Carbidopa
Levodopa
Accordion

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists