NCT00600093

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

3.5 years

First QC Date

January 13, 2008

Last Update Submit

July 24, 2011

Conditions

Parkinson DiseasePerioperative Care

Keywords

Amantadine

Outcome Measures

Primary Outcomes (1)

  • Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).

    28 days

Secondary Outcomes (2)

  • UPDRS score

    2,28 days

  • Pain (vas score), Analgetic drugs requirement

    2 days

Study Arms (1)

A

EXPERIMENTAL
Drug: Amantadine

Interventions

AmantadineDRUG

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

Also known as: PK MERZ
A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (1)

  • 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.

    PMID: 24045608DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Aeyal Raz, MD,PhD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2008

First Posted

January 24, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

IL(1)