Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Parkinson Disease Clinical Trial

Official title:

Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00600093
• Other study ID #: 4332
• Status: Terminated
• Phase: Phase 2
• First received: January 13, 2008
• Last updated: July 24, 2011
• Start date: January 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Perioperative Care

Intervention

Drug:
• Amantadine
IV Amantadine 200mg *1/d at the beginning of surgery and 24 hours following surgery

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).		28 days	Yes
Secondary	UPDRS score		2,28 days	No
Secondary	Pain (vas score), Analgetic drugs requirement		2 days	No