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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Amantadine
Analgesics
Analgesics, Non-Narcotic
Anti-Dyskinesia Agents
Anti-Infective Agents
Antiparkinson Agents
Antiviral Agents
Central Nervous System Agents
Dopamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014