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

This study has been withdrawn prior to enrollment.
(The sponsor decided to postpone the performance of this study to after phase 3)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947037
First Posted: July 27, 2009
Last Update Posted: November 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Intec Pharma Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects

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)

Secondary Outcome Measures:
  • Quality of Life questionnaires
  • Daytime sleepiness
  • Efficacy measures of motor symptoms

Enrollment: 0
Study Start Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extension
Open label extension, 1 arm
Drug: AP-CD/LD

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947037


Locations
Israel
Rambam Medical Center
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
TASMC
Tel Aviv, Israel
Sponsors and Collaborators
Intec Pharma Ltd.
  More Information

Responsible Party: Intec Pharma Ltd.
ClinicalTrials.gov Identifier: NCT00947037     History of Changes
Other Study ID Numbers: IN 12 005
First Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: November 24, 2015
Last Verified: September 2012

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