Clinical trial NCT01313819: The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
Official title: A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Parkinson's Disease
Freezing of Gait
Keywords: Freezing
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: change of FOGQ score
timeFrame: 2 days for each drug
Secondary outcomes:
measure: UPDRS and HY stage
timeFrame: 2 days for each drug
measure: side effect
timeFrame: 2 days, 2 weeks after discharge
measure: Patient global impression
timeFrame: 2 days, 2 weeks after discharge
measure: 4*10m walk test
timeFrame: 2 days for each drug
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Beom S Jeon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.
citation: Giladi N. Medical treatment of freezing of gait. Mov Disord. 2008;23 Suppl 2:S482-8. doi: 10.1002/mds.21914.
citation: Kim YE, Yun JY, Yang HJ, Kim HJ, Gu N, Yoon SH, Cho JY, Jeon BS. Intravenous amantadine for freezing of gait resistant to dopaminergic therapy: a randomized, double-blind, placebo-controlled, cross-over clinical trial. PLoS One. 2012;7(11):e48890. doi: 10.1371/journal.pone.0048890. Epub 2012 Nov 19.