Clincosm LogoSign in Get a demo

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

Sponsor
Jee-Young Lee (Other)
Overall Status
Completed
CT.gov ID
NCT01313845
Collaborator
Seoul National University Boramae Hospital (Other), Samsung Medical Center (Other), Seoul National University Bundang Hospital (Other), Hanyang University (Other)
46
Enrollment
4
Locations
2
Arms
16
Duration (Months)
11.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: amantadine sulfate
  • Drug: 0.9% sodium chloride
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • normal saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. changes in scores on Freezing of Gait Questionnaire [after completion of 5-day schedule of IV amantadine treatment compared with baseline status]

    Secondary Outcome Measures

    1. changes in scores on Freezing of Gait Questionnaire [after 4-weeks of follow-up compared with baseline status]

    2. changes of scores on the Unified Parkinson's disease Rating Scale Part III [after completion of IV amantadine treatment compared with baseline status]

    3. changes of scores on the Unified Parkinson Disease Rating Scale Part III [after 4- weeks of follow-up compared with baseline status]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Korea, Republic of
    2 Hanyang University Medical Center Seoul Korea, Republic of
    3 Samsung Medical Center Seoul Korea, Republic of
    4 Seoul National University Boramae Hospital 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jee-Young Lee, assistant professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT01313845
    Other Study ID Numbers:
    • SB11F001
    First Posted:
    Mar 14, 2011
    Last Update Posted:
    Aug 9, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Parkinson Disease
    Amantadine

    Study Results

    No Results Posted as of Aug 9, 2012