The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

November 9, 2011 updated by: BS Jeon, Seoul National University Hospital

A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy

Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson's disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson's disease.

    We experienced that severe FOG was markedly improved by IV amantadine in the patients who had Parkinson's disease. But IV drug may have placebo effect. Therefore, We designed double blind, placebo controlled study to know whether IV amantadine is effective in the patient with dopaminergic-drug-resistant freezing of gait(FOG).

  2. Cross over study design

    • Compare the change of FOGQ(freezing of gait questionaire) score from the baseline to IV amantadine and placebo drug
    • randomized assigned order of amantadine and placebo drug.
    • investigator of FOG: blinded to the order of drugs
    • each patient has IV drug for 2 days for each drug

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Beom S Jeon, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • age: 30-80 years
  • idiopathic Parkinson's disease
  • The patient must be taking optimised levodopa/DDI therapy (based on investigator's judgement) during OPD observation period, though the patient have FOG-Q score ≥ 10 points even though On-state.

Exclusion Criteria:

  • "Off" freezing:The patient has improved FOG in "On" state
  • clinically significant or unstable medical or surgical condition
  • The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
  • history of seizure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
Give IV amantadine first then IV placebo(normal saline) drug
Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication
ACTIVE_COMPARATOR: Group 2
Give IV placebo drug first then IV amantadine
Drug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of FOGQ score
Time Frame: 2 days for each drug
2 days for each drug

Secondary Outcome Measures

Outcome Measure
Time Frame
UPDRS and HY stage
Time Frame: 2 days for each drug
2 days for each drug
side effect
Time Frame: 2 days, 2 weeks after discharge
2 days, 2 weeks after discharge
Patient global impression
Time Frame: 2 days, 2 weeks after discharge
2 days, 2 weeks after discharge
4*10m walk test
Time Frame: 2 days for each drug
2 days for each drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 10, 2011

First Posted (ESTIMATE)

March 14, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 11, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1012-044-344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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