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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Parkinson`s Disease; Freezing of Gait

Intervention: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Beom S Jeon, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr

Summary

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

Clinical Details

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

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

Primary outcome: change of FOGQ score

Secondary outcome:

UPDRS and HY stage

side effect

Patient global impression

4*10m walk test

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

Eligibility

Minimum age: 30 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr

Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting
Beom S Jeon, MD, PhD, Phone: 82-2-2072-2876, Email: brain@snu.ac.kr
Beom S Jeon, MD, PhD, Principal Investigator
Young Eun Kim, MD, Sub-Investigator
Additional Information

Related publications:

Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5.

Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914. Review. Erratum in: Mov Disord. 2008 Aug 15;23(11):1639-40.

Starting date: April 2011
Last updated: November 9, 2011

Page last updated: August 23, 2015

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