The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
NCT ID: NCT01313819
Last Updated: 2011-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2011-04-30
2011-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Group 1
Give IV amantadine first then IV placebo(normal saline) 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
Group 2
Give IV placebo drug first then IV amantadine
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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BS Jeon
Professor
Principal Investigators
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Beom S Jeon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914.
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.
Other Identifiers
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H-1012-044-344
Identifier Type: -
Identifier Source: org_study_id