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 stageside 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
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