Pilot Study of Maintenance Therapy With Intravenous AMANT... | NCT01190553

Studies
Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

NCT01190553

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Oct 13, 2010Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Parkinson Disease

Interventions

Amantadine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Jun 2012Estimated

First Submitted Date

Aug 26, 2010

First Submission Date that Met QC Criteria

Aug 26, 2010

First Posted Date

Aug 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2010

Last Update Posted Date

Oct 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	IV amantadine treatment	Drug: Amantadine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug	Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of UPDRS scores after 6 months of treatment		6 months
Improvement of dyskinesias score.		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000547	Amantadine

Ancestor Terms

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided