Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01190553
First received: August 26, 2010
Last updated: October 10, 2010
Last verified: August 2010
  Purpose

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 Intervention
Parkinson Disease
Drug: Amantadine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Improvement of UPDRS scores after 6 months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement of dyskinesias score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Ruth Djaldetti, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01190553     History of Changes
Other Study ID Numbers: 0166-10-RMC
Study First Received: August 26, 2010
Last Updated: October 10, 2010
Health Authority: Israel: Ministery of Health

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
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 27, 2014