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Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

NCT ID: NCT01190553

Last Updated: 2010-10-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

IV amantadine treatment

Group Type EXPERIMENTAL

Amantadine

Intervention Type DRUG

Initiation: IV amantadine 200mg/500ml \* 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months

Interventions

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Amantadine

Initiation: IV amantadine 200mg/500ml \* 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months

Intervention Type DRUG

Other Intervention Names

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PK-Merz

Eligibility Criteria

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Inclusion Criteria

* Patients with idiopathic Parkinson disease
* Age\<80
* Patients with no motor improvement under optimal treatment with anti parkinson medications
* Patients with moderate to severe dyskinesias
* Patients with PD with side effects who can not tolerate anti parkinson medications

Exclusion Criteria

* Age\>80
* Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism
* Patients with PD who developed adverse reactions to oral amantadine
* Contraindication of amantadine treatment
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rabin Medical Center

Other Identifiers

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0166-10-RMC

Identifier Type: -

Identifier Source: org_study_id