Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
Primary Purpose
Parkinson's Disease
Status
Withdrawn
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
AP-CD/LD
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility 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
Sites / Locations
- Rambam Medical Center
- Wolfson Medical Center
- Rabin Medical Center
- Sheba Medical Center
- TASMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Extension
Arm Description
Open label extension, 1 arm
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00947037
Brief Title
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor decided to postpone the performance of this study to after phase 3
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intec Pharma Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An extension of study IN 09 004 testing the long term safety of the Accordion Pill Carbidopa/Levodopa (AP-CD/LD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extension
Arm Type
Experimental
Arm Description
Open label extension, 1 arm
Intervention Type
Drug
Intervention Name(s)
AP-CD/LD
Primary Outcome Measure Information:
Title
To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)
Secondary Outcome Measure Information:
Title
Quality of Life questionnaires
Title
Daytime sleepiness
Title
Efficacy measures of motor symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Facility Name
TASMC
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
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