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Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

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ClinicalTrials.gov Identifier: NCT01190553
Recruitment Status : Unknown
Verified August 2010 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 27, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Amantadine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson Medications
Study Start Date : November 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
IV amantadine treatment
Drug: Amantadine
Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months
Other Name: PK-Merz




Primary Outcome Measures :
  1. Improvement of UPDRS scores after 6 months of treatment [ Time Frame: 6 months ]
  2. Improvement of dyskinesias score. [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Responsible Party: Prof. Ruth Djaldetti, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01190553     History of Changes
Other Study ID Numbers: 0166-10-RMC
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: August 2010

Keywords provided by Rabin Medical Center:
amantadine
parkinson disease
dyskinesia

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents