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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intec Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00918177
First received: June 1, 2009
Last updated: May 25, 2014
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: AP09004
Drug: Carbidopa/Levodopa, immediate release
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients

Resource links provided by NLM:


Further study details as provided by Intec Pharma Ltd.:

Primary Outcome Measures:
  • To evaluate blood level profiles and safety of the AP09004 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of AP09004 on motor scores in Parkinson's patients

Estimated Enrollment: 72
Study Start Date: July 2009
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early patients Drug: AP09004 Drug: Carbidopa/Levodopa, immediate release
Experimental: Moderate Patients Drug: AP09004 Drug: Carbidopa/Levodopa, immediate release

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918177

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

No publications provided

Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT00918177     History of Changes
Other Study ID Numbers: IN 09 004
Study First Received: June 1, 2009
Last Updated: May 25, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 30, 2014