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

Jee-Young Lee

Status and phase: Completed; Phase 4

Conditions: Parkinson's Disease

Treatments: Drug: amantadine sulfate; Drug: 0.9% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01313845

SB11F001

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups, including a placebo group

amantadine

Active Comparator group

Description:

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

Treatment:

Drug: amantadine sulfate

placebo

Placebo Comparator group

Description:

administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days

Treatment:

Drug: 0.9% sodium chloride