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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Give IV amantadine first then IV placebo(normal saline) drug |
|
| Group 2 | Active Comparator | Give IV placebo drug first then IV amantadine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change of FOGQ score | 2 days for each drug |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS and HY stage | 2 days for each drug | |
| side effect | 2 days, 2 weeks after discharge | |
| Patient global impression |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beom S Jeon, MD, PhD | Contact | 82-2-2072-2876 | brain@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Beom S Jeon, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9159723 | Background | 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. | |
| 18668620 | Background | Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 3, 2012 | |
| Reset | Feb 2, 2012 | |
| Release | May 5, 2017 | |
| Reset | Nov 2, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 3, 2012 | Feb 2, 2012 | |||
| May 5, 2017 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| 2 days, 2 weeks after discharge |
| 4*10m walk test | 2 days for each drug |
| 23185280 | Derived | 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. |
| Nov 2, 2017 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |