NCT01313845

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

March 10, 2011

Last Update Submit

August 8, 2012

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • changes in scores on Freezing of Gait Questionnaire

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

Secondary Outcomes (3)

  • changes in scores on Freezing of Gait Questionnaire

    after 4-weeks of follow-up compared with baseline status

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

    after completion of IV amantadine treatment compared with baseline status

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

    after 4- weeks of follow-up compared with baseline status

Study Arms (2)

amantadine

ACTIVE COMPARATOR

administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days

Drug: amantadine sulfate

placebo

PLACEBO COMPARATOR

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

Interventions

amantadine sulfateDRUG

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

Also known as: PK-merz
amantadine
0.9% sodium chlorideDRUG

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

Also known as: normal saline
placebo

Eligibility Criteria

Age30 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Boramae Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

AmantadineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Jinwhan Cho, M.D.,Ph.D.

    Department of Neurology, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 14, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

KR(4)