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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
amantadine sulfate
0.9% sodium chloride
Sponsored by
Jee-Young Lee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Hanyang University Medical Center
  • Samsung Medical Center
  • Seoul National University Boramae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

amantadine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes in scores on Freezing of Gait Questionnaire

Secondary Outcome Measures

changes in scores on Freezing of Gait Questionnaire
changes of scores on the Unified Parkinson's disease Rating Scale Part III
changes of scores on the Unified Parkinson Disease Rating Scale Part III

Full Information

First Posted
March 10, 2011
Last Updated
August 8, 2012
Sponsor
Jee-Young Lee
Collaborators
Seoul National University Boramae Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Hanyang University
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1. Study Identification

Unique Protocol Identification Number
NCT01313845
Brief Title
Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease
Official Title
Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jee-Young Lee
Collaborators
Seoul National University Boramae Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Hanyang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
amantadine
Arm Type
Active Comparator
Arm Description
administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days
Intervention Type
Drug
Intervention Name(s)
amantadine sulfate
Other Intervention Name(s)
PK-merz
Intervention Description
infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
normal saline
Intervention Description
infusion of normal saline 500ml/bottle over 3 hours twice a day
Primary Outcome Measure Information:
Title
changes in scores on Freezing of Gait Questionnaire
Time Frame
after completion of 5-day schedule of IV amantadine treatment compared with baseline status
Secondary Outcome Measure Information:
Title
changes in scores on Freezing of Gait Questionnaire
Time Frame
after 4-weeks of follow-up compared with baseline status
Title
changes of scores on the Unified Parkinson's disease Rating Scale Part III
Time Frame
after completion of IV amantadine treatment compared with baseline status
Title
changes of scores on the Unified Parkinson Disease Rating Scale Part III
Time Frame
after 4- weeks of follow-up compared with baseline status

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinwhan Cho, M.D.,Ph.D.
Organizational Affiliation
Department of Neurology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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