NCT01313819

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Parkinson's Disease
• Freezing of Gait

Interventions

Type	Name	Description
DRUG	PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj	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

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-03-14
• Last updated: 2011-11-11

Locations

1 site across 1 country: South Korea