Effect of Intravenous Amantadine on Gait Freezing in Park... | NCT01313845

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

NCT01313845

Sponsor

Jee-Young Lee

Status

Completed

Last Update Posted

Aug 9, 2012Estimated

Enrollment

46Actual

Phase

Phase 4

Conditions

Parkinson's Disease

Interventions

amantadine sulfate
0.9% sodium chloride

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Mar 10, 2011

First Submission Date that Met QC Criteria

Mar 10, 2011

First Posted Date

Mar 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2012

Last Update Posted Date

Aug 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jee-Young Lee, assistant professor, Seoul National University HospitalSponsor-Investigator

Lead Sponsor

Jee-Young LeeOTHER

Collaborators

Name	Class
Seoul National University Boramae Hospital	OTHER
Samsung Medical Center	OTHER
Seoul National University Bundang Hospital	OTHER
Hanyang University

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
amantadine	Active Comparator	administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days	Drug: amantadine sulfate
placebo	Placebo Comparator	administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days	Drug: 0.9% sodium chloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amantadine sulfate	Drug	infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day	amantadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in scores on Freezing of Gait Questionnaire		after completion of 5-day schedule of IV amantadine treatment compared with baseline status

Secondary Outcomes

Measure	Description	Time Frame
changes in scores on Freezing of Gait Questionnaire		after 4-weeks of follow-up compared with baseline status
changes of scores on the Unified Parkinson's disease Rating Scale Part III		after completion of IV amantadine treatment compared with baseline status

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jinwhan Cho, M.D.,Ph.D.	Department of Neurology, Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam			South Korea
Hanyang University Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000547	Amantadine
D012965	Sodium Chloride
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided