Back to resultsPerioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
Primary Purpose
Parkinson Disease, Perioperative Care
Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Amantadine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Amantadine
Eligibility 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.
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
Secondary Outcome Measures
UPDRS score
Pain (vas score), Analgetic drugs requirement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00600093
Brief Title
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
Official Title
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Terminated
Why Stopped
PI leaving the institute for a fellowship.
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Perioperative Care
Keywords
Amantadine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Amantadine
Other Intervention Name(s)
PK MERZ
Intervention Description
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery
Primary Outcome Measure Information:
Title
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
UPDRS score
Time Frame
2,28 days
Title
Pain (vas score), Analgetic drugs requirement
Time Frame
2 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aeyal Raz, MD,PhD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
24045608
Citation
Raz A, Lev N, Orbach-Zinger S, Djaldetti R. Safety of perioperative treatment with intravenous amantadine in patients with Parkinson disease. Clin Neuropharmacol. 2013 Sep-Oct;36(5):166-9. doi: 10.1097/WNF.0b013e31829bd066.
Results Reference
derived
Learn more about this trial
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
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