NCT01190553

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2010

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 13, 2010

Status Verified

August 1, 2010

Enrollment Period

1.1 years

First QC Date

August 26, 2010

Last Update Submit

October 10, 2010

Conditions

Parkinson Disease

Keywords

amantadineparkinson diseasedyskinesia

Outcome Measures

Primary Outcomes (2)

  • Improvement of UPDRS scores after 6 months of treatment

    6 months

  • Improvement of dyskinesias score.

    6 months

Study Arms (1)

Treatment

EXPERIMENTAL

IV amantadine treatment

Drug: Amantadine

Interventions

AmantadineDRUG

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

Also known as: PK-Merz
Treatment

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson DiseaseDyskinesias

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2010

First Posted

August 27, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

October 13, 2010

Record last verified: 2010-08