Perioperative Treatment of Parkinsonian Patients With Par... | NCT00600093

Studies
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

NCT00600093

Sponsor

Rabin Medical Center

Status

Terminated

Last Update Posted

Jul 26, 2011Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Parkinson Disease
Perioperative Care

Interventions

Amantadine

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

Jul 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI leaving the institute for a fellowship.

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Jan 13, 2008

First Submission Date that Met QC Criteria

Jan 13, 2008

First Posted Date

Jan 24, 2008Estimated

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

Jul 24, 2011

Last Update Posted Date

Jul 26, 2011Estimated

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 this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Drug: Amantadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug	IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).		28 days

Secondary Outcomes

Measure	Description	Time Frame
UPDRS score		2,28 days
Pain (vas score), Analgetic drugs requirement		2 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.

Exclusion Criteria:

Cardiac and neurosurgical procedures
Inability to sign informed Consent
allergy to Amantadine
Congestive heart failure
Arrythmia (including bradycardia below 55 bpm)
renal failure (creatinin above 1.5)
If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aeyal Raz, MD,PhD	Rabin Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rabin Medical Center		Petah Tikva			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24045608	Derived	Raz A, Lev N, Orbach-Zinger S, Djaldetti R. Safety of perioperative treatment with intravenous amantadine in patients with Parkinson disease. Clin Neuropharmacol. 2013 Sep-Oct;36(5):166-9. doi: 10.1097/WNF.0b013e31829bd066.

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

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons