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NCT Number: NCT01313845

Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease

A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease.

* administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged * follow-up after administration of IV amantadine for 4 weeks * allocation ratio of amantadine:normal saline is 2:1

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with Parkinson's disease. The study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with Parkinson's disease, but not in patients with parkinson-plus syndromes.

This study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with Parkinson's disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's Disease Brain Bank criteria
  • presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or more
  • having been treated with oral dopamine replacement therapy for 6 months or more
  • score of Korean version of mini-mental status examination is 20 or more

Exclusion criteria

  • presence of significant cognitive dysfunction, behavioral or psychiatric disorders
  • presence of severe cardiac disease
  • presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy
  • participation to other clinical trial within 4 weeks
  • pregnancy or lactating women
  • hypersensitivity to study drugs
  • history of intoxication to heavy metals

Treatment and study plan

amantadine sulfate

Drug

infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day

Other names: PK-merz

0.9% Sodium Chloride

Drug

infusion of normal saline 500ml/bottle over 3 hours twice a day

Other names: normal saline

Primary outcomes

  1. changes in scores on Freezing of Gait Questionnaire

    Time frame: after completion of 5-day schedule of IV amantadine treatment compared with baseline status

Secondary outcomes

  1. changes in scores on Freezing of Gait Questionnaire

    Time frame: after 4-weeks of follow-up compared with baseline status

  2. changes of scores on the Unified Parkinson's disease Rating Scale Part III

    Time frame: after completion of IV amantadine treatment compared with baseline status

  3. changes of scores on the Unified Parkinson Disease Rating Scale Part III

    Time frame: after 4- weeks of follow-up compared with baseline status

Sponsors and collaborators

Lead sponsor

Jee-Young Lee

Other

Collaborators

  • Hanyang University
  • Samsung Medical Center
  • Seoul National University Boramae Hospital
  • Seoul National University Bundang Hospital

Registry information

Official study title

Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 14, 2011
Registry last updated
Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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