Continuation Treatment Protocol for Patients Who Particip... | NCT01709461

Studies
Continuation Treatment Protocol for Patients Who Participated in the Adagio TVP 1012/501 Clinical Trial

NCT01709461

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Oct 18, 2012Estimated

Enrollment

12Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 14, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2012

Last Update Posted Date

Oct 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

the purpose of the study is to extend the use of Rasagelin Mesylate 1mg per day by subjects who participated in the Adagio TVP 1012/501 according to form 4a for additional three years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects who are willing to contiue this treatment.
subjects who took part in the TVP 1012/501 clinical trail.

Exclusion Criteria:

subjects who didn't take part in the TVP 1012/501 clinical trail.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

subjects who took part in the TVP 1012/501 clinical trial and willing to contiue receiving Rasgiline Mesylate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ruth Djaldetti, Professor	Contact	972-9378218/9		ruthdjal@clalit.org.il
Yaniv roditi, Msc	Contact	972-39236843		yar@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center Beilinson Campus		Petach Tiqva	Central District	49100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided