Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

This study is not yet open for participant recruitment.
Verified August 2012 by Intec Pharma Ltd.
Sponsor:
Information provided by (Responsible Party):
Intec Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00947037
First received: July 24, 2009
Last updated: December 6, 2012
Last verified: August 2012
  Purpose

An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)


Condition Intervention Phase
Parkinson's Disease
Drug: AP-CD/LD
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

Resource links provided by NLM:


Further study details as provided by Intec Pharma Ltd.:

Primary Outcome Measures:
  • To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life questionnaires [ Designated as safety issue: No ]
  • Daytime sleepiness [ Designated as safety issue: Yes ]
  • Efficacy measures of motor symptoms

Estimated Enrollment: 36
Study Start Date: February 2013
Arms Assigned Interventions
Experimental: Extension
Open label extension, 1 arm
Drug: AP-CD/LD

  Eligibility

Ages Eligible for Study:   30 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject satisfactorily completed study IN 09 004 and, in the opinion of the investigator, will benefit from participation in the extension study
  • 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 hours OFF a day at the discretion of the PI (does not include early morning akinesia or nocturnal akinesia)
  • Subject that has been treated for at least 3 months prior to the study with 500-1000 mg Levodopa + DDCI, in 4 or more divided doses per day
  • Hoehn and Yahr stages I-III
  • Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study
  • Prepared and able to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study.

Exclusion Criteria

  • Subject has undergone Deep brain stimulation (DBS) or any other neurological surgical procedure that affects neurological symptoms (e.g tremor, rigidity, stiffness, slowed movement, and walking problem)
  • Subjects with any gastrointestinal surgery other than appendectomy or herniotomy, recent history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, intestinal obstruction, or frequent nausea or emesis or diarrhea which, in the opinion of the investigator, contraindicates his/her participation
  • Subjects with a recent history of clinically defined GERD, peptic ulcer or any gastrointestinal disorder likely to influence drug absorption which, in the opinion of the investigator, contraindicates his/her participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947037

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: I Arik    972-4-854-2830      
Principal Investigator: I Schlesinger, MD         
Wolfson Medical Center Not yet recruiting
Holon, Israel
Contact: M Israelson    972-3-5028513      
Principal Investigator: M. Anca, MD         
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel
Contact: Y Ordetti    972-3-937-8219      
Principal Investigator: R. Djaldetti, Prof. MD.         
Sheba Medical Center Not yet recruiting
Ramat Gan, Israel
Contact: E. Kozlova    03-530 4931      
Principal Investigator: O. Cohen, MD         
TASMC Not yet recruiting
Tel Aviv, Israel
Contact: Y. Knaani    972-3-6973061      
Principal Investigator: T. Gurevich, MD         
Sponsors and Collaborators
Intec Pharma Ltd.
  More Information

No publications provided

Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT00947037     History of Changes
Other Study ID Numbers: IN 12 005
Study First Received: July 24, 2009
Last Updated: December 6, 2012
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
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014