- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01190553
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE
October 10, 2010 updated by: Rabin Medical Center
Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
IV amantadine treatment
|
Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement of UPDRS scores after 6 months of treatment
Time Frame: 6 months
|
6 months
|
Improvement of dyskinesias score.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
August 26, 2010
First Submitted That Met QC Criteria
August 26, 2010
First Posted (Estimate)
August 27, 2010
Study Record Updates
Last Update Posted (Estimate)
October 13, 2010
Last Update Submitted That Met QC Criteria
October 10, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Amantadine
Other Study ID Numbers
- 0166-10-RMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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