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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00947037
• Other study ID #: IN 12 005
• Status: Withdrawn
• Phase: Phase 2
• First received: July 24, 2009
• Last updated: November 23, 2015
• Start date: August 2012

Study information

• Verified date: September 2012
• Source: Intec Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 95 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• AP-CD/LD

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Intec Pharma Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess patient and investigator global evaluation of, and degree of satisfaction with, AP-CD/LD (CGI, GSS)			Yes
Secondary	Quality of Life questionnaires			No
Secondary	Daytime sleepiness			Yes
Secondary	Efficacy measures of motor symptoms