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

Parkinson's Disease Clinical Trial

Official title:

Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313845
• Other study ID #: SB11F001
• Status: Completed
• Phase: Phase 4
• First received: March 10, 2011
• Last updated: August 8, 2012
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• amantadine sulfate
infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day
• 0.9% sodium chloride
infusion of normal saline 500ml/bottle over 3 hours twice a day

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Boramae Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Jee-Young Lee	Hanyang University, Samsung Medical Center, Seoul National University Boramae Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in scores on Freezing of Gait Questionnaire		after completion of 5-day schedule of IV amantadine treatment compared with baseline status	No
Secondary	changes in scores on Freezing of Gait Questionnaire		after 4-weeks of follow-up compared with baseline status	No
Secondary	changes of scores on the Unified Parkinson's disease Rating Scale Part III		after completion of IV amantadine treatment compared with baseline status	No
Secondary	changes of scores on the Unified Parkinson Disease Rating Scale Part III		after 4- weeks of follow-up compared with baseline status	No