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

July 24, 2009
May 25, 2014
Not Provided
Not Provided
To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS) [ Designated as safety issue: Yes ]
Patient and Investigator's clinical global improvement scales [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00947037 on ClinicalTrials.gov Archive Site
  • Quality of Life questionnaires [ Designated as safety issue: No ]
  • Daytime sleepiness [ Designated as safety issue: Yes ]
  • Efficacy measures of motor symptoms
Tolerability and safety [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study
Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension Study

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Drug: AP-CD/LD
Experimental: Extension
Open label extension, 1 arm
Intervention: Drug: AP-CD/LD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
36
Not Provided
Not Provided

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
Both
30 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00947037
IN 12 005
Yes
Intec Pharma Ltd.
Intec Pharma Ltd.
Not Provided
Not Provided
Intec Pharma Ltd.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP