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Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease

NCT ID: NCT01313845

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-06-30

Brief Summary

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A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease.

* administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged
* follow-up after administration of IV amantadine for 4 weeks
* allocation ratio of amantadine:normal saline is 2:1

Detailed Description

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Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with Parkinson's disease. The study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with Parkinson's disease, but not in patients with parkinson-plus syndromes.

This study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with Parkinson's disease.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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amantadine

administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days

Group Type ACTIVE_COMPARATOR

amantadine sulfate

Intervention Type DRUG

infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day

placebo

administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

infusion of normal saline 500ml/bottle over 3 hours twice a day

Interventions

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amantadine sulfate

infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day

Intervention Type DRUG

0.9% sodium chloride

infusion of normal saline 500ml/bottle over 3 hours twice a day

Intervention Type DRUG

Other Intervention Names

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PK-merz normal saline

Eligibility Criteria

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Inclusion Criteria

* the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's Disease Brain Bank criteria
* presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or more
* having been treated with oral dopamine replacement therapy for 6 months or more
* score of Korean version of mini-mental status examination is 20 or more

Exclusion Criteria

* presence of significant cognitive dysfunction, behavioral or psychiatric disorders
* presence of severe cardiac disease
* presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy
* participation to other clinical trial within 4 weeks
* pregnancy or lactating women
* hypersensitivity to study drugs
* history of intoxication to heavy metals
Minimum Eligible Age

30 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Boramae Hospital

OTHER

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Jee-Young Lee

OTHER

Sponsor Role lead

Responsible Party

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Jee-Young Lee

assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jinwhan Cho, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Samsung Medical Center

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Hanyang University Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Seoul National University Boramae Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SB11F001

Identifier Type: -

Identifier Source: org_study_id