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

Freezing of Gait Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01313819
• Other study ID #: H-1012-044-344
• Status: Unknown status
• Phase: Phase 4
• First received: March 10, 2011
• Last updated: November 9, 2011
• Start date: April 2011
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: Seoul National University Hospital
• Contact: Beom S Jeon, MD, PhD
• Phone: 82-2-2072-2876
• Email: brain[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease
• Parkinson`s Disease

Intervention

Drug:
• PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj
IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of FOGQ score		2 days for each drug
Secondary	UPDRS and HY stage		2 days for each drug
Secondary	side effect		2 days, 2 weeks after discharge
Secondary	Patient global impression		2 days, 2 weeks after discharge
Secondary	4*10m walk test		2 days for each drug