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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Intec Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT00947037
First received: July 24, 2009
Last updated: May 25, 2014
Last verified: September 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
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
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: 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

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: 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 October 01, 2014