Your session is about to expire
← Back to Search
Dopamine Agonist
AP CD/LD for Parkinson's Disease
Phase 3
Waitlist Available
Led By Peter LeWitt, MD
Research Sponsored by Intec Pharma Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study 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).
Eligible Conditions
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Unified Parkinson's Disease Rating Scale (UPDRS)
Secondary outcome measures
Change in Parkinson's disease Questionnaire - 39 items (PDQ39).
Safety (Adverse Events, Safety laboratory, Vital signs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: AP CD/LDExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Intec Pharma Ltd.Lead Sponsor
6 Previous Clinical Trials
611 Total Patients Enrolled
Peter LeWitt, MDPrincipal InvestigatorHenry Ford Hospital - West Bloomfield
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger