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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 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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

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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.
~53 spots leftby Apr 2025