Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 10, 2011
August 8, 2012
February 2011
June 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01313845 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease
Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With 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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • Drug: amantadine sulfate
    infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day
    Other Name: PK-merz
  • Drug: 0.9% sodium chloride
    infusion of normal saline 500ml/bottle over 3 hours twice a day
    Other Name: normal saline
  • Active Comparator: amantadine
    administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days
    Intervention: Drug: amantadine sulfate
  • Placebo Comparator: placebo
    administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days
    Intervention: Drug: 0.9% sodium chloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01313845
SB11F001
Yes
Jee-Young Lee, Seoul National University Hospital
Jee-Young Lee
  • Seoul National University Boramae Hospital
  • Samsung Medical Center
  • Seoul National University Bundang Hospital
  • Hanyang University
Principal Investigator: Jinwhan Cho, M.D.,Ph.D. Department of Neurology, Samsung Medical Center
Seoul National University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP