The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
Primary Purpose
Parkinson's Disease, Freezing of Gait
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Freezing
Eligibility Criteria
Inclusion Criteria
- age: 30-80 years
- idiopathic Parkinson's disease
- The patient must be taking optimised levodopa/DDI therapy (based on investigator's judgement) during OPD observation period, though the patient have FOG-Q score ≥ 10 points even though On-state.
Exclusion Criteria:
- "Off" freezing:The patient has improved FOG in "On" state
- clinically significant or unstable medical or surgical condition
- The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
- history of seizure.
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Give IV amantadine first then IV placebo(normal saline) drug
Give IV placebo drug first then IV amantadine
Outcomes
Primary Outcome Measures
change of FOGQ score
Secondary Outcome Measures
UPDRS and HY stage
side effect
Patient global impression
4*10m walk test
Full Information
NCT ID
NCT01313819
First Posted
March 10, 2011
Last Updated
November 9, 2011
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01313819
Brief Title
The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
Official Title
A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson's disease
Detailed Description
Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson's disease.
We experienced that severe FOG was markedly improved by IV amantadine in the patients who had Parkinson's disease. But IV drug may have placebo effect. Therefore, We designed double blind, placebo controlled study to know whether IV amantadine is effective in the patient with dopaminergic-drug-resistant freezing of gait(FOG).
Cross over study design
Compare the change of FOGQ(freezing of gait questionaire) score from the baseline to IV amantadine and placebo drug
randomized assigned order of amantadine and placebo drug.
investigator of FOG: blinded to the order of drugs
each patient has IV drug for 2 days for each drug
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Freezing of Gait
Keywords
Freezing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Give IV amantadine first then IV placebo(normal saline) drug
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Give IV placebo drug first then IV amantadine
Intervention Type
Drug
Intervention Name(s)
PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
Intervention Description
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication
Primary Outcome Measure Information:
Title
change of FOGQ score
Time Frame
2 days for each drug
Secondary Outcome Measure Information:
Title
UPDRS and HY stage
Time Frame
2 days for each drug
Title
side effect
Time Frame
2 days, 2 weeks after discharge
Title
Patient global impression
Time Frame
2 days, 2 weeks after discharge
Title
4*10m walk test
Time Frame
2 days for each drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
age: 30-80 years
idiopathic Parkinson's disease
The patient must be taking optimised levodopa/DDI therapy (based on investigator's judgement) during OPD observation period, though the patient have FOG-Q score ≥ 10 points even though On-state.
Exclusion Criteria:
"Off" freezing:The patient has improved FOG in "On" state
clinically significant or unstable medical or surgical condition
The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
history of seizure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beom S Jeon, MD, PhD
Phone
82-2-2072-2876
Email
brain@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
Phone
82-2-2072-2876
Email
brain@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Beom S Jeon, MD, PhD
First Name & Middle Initial & Last Name & Degree
Young Eun Kim, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
9159723
Citation
Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
Results Reference
background
PubMed Identifier
18668620
Citation
Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914. Erratum In: Mov Disord. 2008 Aug 15;23(11):1639-40.
Results Reference
background
PubMed Identifier
23185280
Citation
Kim YE, Yun JY, Yang HJ, Kim HJ, Gu N, Yoon SH, Cho JY, Jeon BS. Intravenous amantadine for freezing of gait resistant to dopaminergic therapy: a randomized, double-blind, placebo-controlled, cross-over clinical trial. PLoS One. 2012;7(11):e48890. doi: 10.1371/journal.pone.0048890. Epub 2012 Nov 19.
Results Reference
derived
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The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
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