Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

July 24, 2011 updated by: Rabin Medical Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Amantadine
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
Other Names:
  • PK MERZ

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Aeyal Raz, MD,PhD, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 13, 2008

First Submitted That Met QC Criteria

January 13, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 24, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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