An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients

The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ashkelon,, Israel
    • Barzilai Medical Center, Department of Neurology, Movement disorders unit,
  • Beer-Sheva, Israel
    • Department of Neurology, Clalit University Medical Center
  • Haifa, Israel
    • Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease
  • Holon, Israel
    • Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.
  • Petah Tikva, Israel
    • Rabin Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
  • Tel Aviv, Israel
    • TASMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Subjects between the ages of 18 and 75 years of age inclusive;
• For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per day.
• For group 3 only: Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2-3 hours OFF a day at the discretion of the PI (does not include early morning akinesia). Only patients with end of dose wearing off for at least 3 months will be included.
• For moderate patients only: patients who are currently treated with IR-Carbidopa/Levodopa containing 600-900mg Levodopa, in divided dose, per day.
• Subject has been stable at current CD/LD dose for at least 1 months
• Hoehn and Yahr stages I-III
• If subject is taking dopamine agonists, the dose has been stable for at least 1 month
• Other then Parkinson's disease, the subject is in satisfactory health, as assessed by physical examination, blood test (biochemistry and hematology). No abnormality on clinical examination and blood tests that in the opinion of the Physician responsible will compromise safety or interfere with study procedures.

Exclusion Criteria:

• Subjects who have participated in another clinical trial within the last 30 days;
• Subjects with atypical Parkinsonism
• Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
• Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
• Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
• Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
• History of drug or alcohol abuse.
• Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
• Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early patients	Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release
Experimental: Moderate Patients	Drug: AP09004; Drug: Carbidopa/Levodopa, immediate release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate blood level profiles and safety of the AP09004

Secondary Outcome Measures

Outcome Measure
Efficacy of AP09004 on motor scores in Parkinson's patients

Collaborators and Investigators

• Sponsor: Intec Pharma Ltd.
• Investigators: Principal Investigator: T Gurevich, MD, Tel-Aviv Sourasky Medical Center; Principal Investigator: R. Djaldetti, Prof. MD, Rabin Medical Center; Principal Investigator: O. Cohen, MD, Sheba Medical Center; Principal Investigator: Ilana Schlesinger Schlesinger, MD, Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease; Principal Investigator: Ron Milo, M.D, Barzilai Medical Center, Department of Neurology, Movement disorders unit, Ashkelon, Israel; Principal Investigator: Peter Farkas, M.D, Department of Neurology, Clalit University Medical Center; Principal Investigator: Marieta Anca-Herschkovitsch, M.D, Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: June 1, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 25, 2014
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunologic Factors; Dopamine Agonists; Dopamine Agents; Adjuvants, Immunologic; Antiparkinson Agents; Anti-Dyskinesia Agents; Aromatic Amino Acid Decarboxylase Inhibitors; Levodopa; Carbidopa; Carbidopa, levodopa drug combination
• Other Study ID Numbers: IN 09 004