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Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Sponsor
Rabin Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00600093
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
42
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
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 :
Jan 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA). [28 days]

    Secondary Outcome Measures

    1. UPDRS score [2,28 days]

    2. Pain (vas score), Analgetic drugs requirement [2 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rabin Medical Center Petah Tikva Israel

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00600093
    Other Study ID Numbers:
    • 4332
    First Posted:
    Jan 24, 2008
    Last Update Posted:
    Jul 26, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Amantadine
    Additional relevant MeSH terms:
    Parkinson Disease
    Amantadine

    Study Results

    No Results Posted as of Jul 26, 2011