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Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600093
Recruitment Status : Terminated (PI leaving the institute for a fellowship.)
First Posted : January 24, 2008
Last Update Posted : July 26, 2011
Information provided by:
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Perioperative Care Drug: Amantadine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
Study Start Date : January 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A Drug: Amantadine
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
Other Name: PK MERZ

Primary Outcome Measures :
  1. Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA). [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. UPDRS score [ Time Frame: 2,28 days ]
  2. Pain (vas score), Analgetic drugs requirement [ Time Frame: 2 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600093

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Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
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Principal Investigator: Aeyal Raz, MD,PhD Rabin Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Aeyal Raz, MD, PhD, Rabin Medical Center Identifier: NCT00600093     History of Changes
Other Study ID Numbers: 4332
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Keywords provided by Rabin Medical Center:
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents