Freezing of Gait, Parkinson's Disease
Conditions
Keywords
Freezing
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
Interventions
DRUGPK-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
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of FOGQ score | 2 days for each drug |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactBeom S Jeon, MD, PhD
Outcome results
None listed