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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01313845

Enrollment

Registered

2011-03-14

Start date

2011-02-28

Completion date

2012-06-30

Last updated

2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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

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.

Interventions

DRUGamantadine sulfate

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

DRUG0.9% sodium chloride

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
changes in scores on Freezing of Gait Questionnaire	after completion of 5-day schedule of IV amantadine treatment compared with baseline status

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026