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Dopamine Agonist

AP-CD/LD for Parkinson's Disease (Accordance Trial)

Phase 3
Waitlist Available
Led By Peter A 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 baseline through study completion, an average of 27 weeks
Awards & highlights

Summary

The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 27 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 27 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline through study completion, an average of 27 weeks, in the percentage of daily "Off time" during waking hours

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AP-CD/LDExperimental Treatment2 Interventions
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 and Placebo IR Carbidopa/ levodopa
Group II: SINEMET®Active Control2 Interventions
IR Carbidopa/ levodopa tablets 25/100 mg at least 4 times a day and placebo AP-CD/LD

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Who is running the clinical trial?

Intec Pharma Ltd.Lead Sponsor
6 Previous Clinical Trials
651 Total Patients Enrolled
Peter A LeWitt, MDPrincipal InvestigatorHenry Ford Hospital - West Bloomfield
1 Previous Clinical Trials
~44 spots leftby Sep 2025
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