Clinical Trial Details

Overview

Research Study Summary

A Phase III, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study Comparing the Efficacy and Safety of gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson's Disease Patients

Purpose

This research study will assess the safety, tolerability and effectiveness of Accordion Pill Carbidopa/Levodopa (AP-CD/LD) compared to Immediate Release Carbidopa/Levodopa (IR CD/LD) (Sinemet) in patients with fluctuating Parkinson’s Disease (PD).

To Learn more

CW ID: 214086
Date Last Changed: April 11, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
35 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Intec Pharma, Ltd.
Duration
32 Weeks
Facility Type
N/A

Eligibility

Inclusion Criteria
  • Diagnosed with idiopathic Parkinson's disease
  • Patient has a good response to Levodopa and is taking at least 4 doses of levodopa containing medication per day
  • Able to complete a Hauser home diary and can tell the difference between "On and Off" time
Exclusion Criteria:
  • Participation in another drug clinical trial within 28 days prior to initial screening assessment
  • Atypical Parkinsonism (subjects with Parkinsonian features caused by disorder such as multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies or multiple brain infarcts)
  • Significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which contradicts participation in this study
  • Unable to swallow large pills (e.g., large vitamin pills)
  • History of melanoma or suspicious skin lesion which could be a melanoma
  • Narrow-angle glaucoma
  • History of small bowel or gastric surgery (except for appendectomy or hernioplasty) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis.
  • Active peptic ulcer

Contact

Leigh Donharl
USF Health Byrd Alzheimer's Institute
4001 East Fletcher Avenue
Tampa, FL 33613
Phone: 813 396-0763

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