The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

Study Overview
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Brief Summary
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Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson's disease

Detailed Description
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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

Official Title
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A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

Conditions
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Parkinson's Disease, Freezing of Gait

Intervention / Treatment
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* Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Give IV amantadine first then IV placebo(normal saline) drug | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj<br>* 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<br>|
| Active Comparator: Group 2<br>Give IV placebo drug first then IV amantadine | Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of FOGQ score |  | 2 days for each drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS and HY stage |  | 2 days for each drug | 
| side effect |  | 2 days, 2 weeks after discharge | 
| Patient global impression |  | 2 days, 2 weeks after discharge | 
| 4*10m walk test |  | 2 days for each drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Freezing