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

Phase 4

• Conditions: Parkinson's Disease; Freezing of Gait
• Interventions: Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj

• Registration Number: NCT01313819
• Lead Sponsor: Seoul National University Hospital

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

1. 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).

2. 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

Study Timeline

• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-14
• Study Start: 2011-04
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-09
• Last Update Posted: 2011-11-11
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj	Give IV amantadine first then IV placebo(normal saline) drug
Group 2	PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj	Give IV placebo drug first then IV amantadine

Primary Outcome Measures

Name	Time	Method
change of FOGQ score	2 days for each drug

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of