Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

Parkinson Disease Clinical Trial

Official title:

Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01190553
• Other study ID #: 0166-10-RMC
• Status: Not yet recruiting
• Phase: N/A
• First received: August 26, 2010
• Last updated: October 10, 2010
• Start date: November 2010
• Est. completion date: June 2012

Study information

• Verified date: August 2010
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministery of Health
• Study type: Interventional

Clinical Trial Summary

This is a pilot study for Maintenance Intravenous Treatment with AMANTADINE in patient with PARKINSON'S Disease who are not well balanced with medical treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with idiopathic Parkinson disease

• Age<80

• Patients with no motor improvement under optimal treatment with anti parkinson medications

• Patients with moderate to severe dyskinesias

• Patients with PD with side effects who can not tolerate anti parkinson medications

Exclusion Criteria:

• Age>80

• Patients with Parkinson syndromes, vascular parkinsonism or drug-induced parkinsonism

• Patients with PD who developed adverse reactions to oral amantadine

• Contraindication of amantadine treatment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Amantadine
Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of UPDRS scores after 6 months of treatment		6 months	No
Primary	Improvement of dyskinesias score.		6 months	No