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Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

This study has been terminated.
(PI leaving the institute for a fellowship.)
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT00600093
First received: January 13, 2008
Last updated: July 24, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention Phase
Parkinson Disease
Perioperative Care
 Drug: Amantadine
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • UPDRS score [ Time Frame: 2,28 days ] [ Designated as safety issue: No ]
  • Pain (vas score), Analgetic drugs requirement [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Amantadine
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
Other Name: PK MERZ

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600093

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

No publications provided

Responsible Party: Aeyal Raz, MD, PhD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT00600093     History of Changes
Other Study ID Numbers: 4332
Study First Received: January 13, 2008
Last Updated: July 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Amantadine

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013