Back to resultsPilot Study of Maintenance Therapy With Intravenous AMANTADINE
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Amantadine
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring amantadine, parkinson disease, dyskinesia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
IV amantadine treatment
Outcomes
Primary Outcome Measures
Improvement of UPDRS scores after 6 months of treatment
Improvement of dyskinesias score.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01190553
Brief Title
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE
Official Title
Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
amantadine, parkinson disease, dyskinesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
IV amantadine treatment
Intervention Type
Drug
Intervention Name(s)
Amantadine
Other Intervention Name(s)
PK-Merz
Intervention Description
Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months
Primary Outcome Measure Information:
Title
Improvement of UPDRS scores after 6 months of treatment
Time Frame
6 months
Title
Improvement of dyskinesias score.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE
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