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

This study has been completed.
Sponsor:
Collaborators:
Seoul National University Boramae Hospital
Samsung Medical Center
Seoul National University Bundang Hospital
Hanyang University
Information provided by (Responsible Party):
Jee-Young Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01313845
First received: March 10, 2011
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Parkinson's Disease
 Drug: amantadine sulfate
Drug: 0.9% sodium chloride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • changes in scores on Freezing of Gait Questionnaire [ Time Frame: after completion of 5-day schedule of IV amantadine treatment compared with baseline status ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in scores on Freezing of Gait Questionnaire [ Time Frame: after 4-weeks of follow-up compared with baseline status ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • changes of scores on the Unified Parkinson Disease Rating Scale Part III [ Time Frame: after 4- weeks of follow-up compared with baseline status ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amantadine
administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days
 Drug: amantadine sulfate
infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day
Other Name: PK-merz
Placebo Comparator: placebo
administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days
 Drug: 0.9% sodium chloride
infusion of normal saline 500ml/bottle over 3 hours twice a day
Other Name: normal saline

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01313845

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Hanyang University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Jee-Young Lee
Seoul National University Boramae Hospital
Samsung Medical Center
Seoul National University Bundang Hospital
Hanyang University
Investigators
Principal Investigator: Jinwhan Cho, M.D.,Ph.D. Department of Neurology, Samsung Medical Center
  More Information

No publications provided

Responsible Party: Jee-Young Lee, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01313845     History of Changes
Other Study ID Numbers: SB11F001
Study First Received: March 10, 2011
Last Updated: August 8, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013