Brooklyn, New York 11203

  • Parkinson's Disease

Purpose:

The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.


Criteria:

Main Inclusion Criteria: - Idiopathic Parkinson's disease for at least 5 years - Presence of motor fluctuations and dyskinesia - Stable regimen of levodopa/carbidopa for 30 days - At least 25% response/improvement in UPDRS part III scores after dosing with regular PD medications - MMSE score of 25 or higher Main Exclusion Criteria: - Atypical or secondary parkinsonism. - Prior use of neuroleptic agents. - History of intracranial procedures for PD. - Active psychosis. - History of drug or alcohol abuse in past 12 months. - Cardiac conduction system abnormality. - Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.


Study is Available At:


Original ID:

ASBI-501


NCT ID:

NCT00623363


Secondary ID:


Study Acronym:


Brief Title:

Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

40 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Asubio Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Study Dates

Start Date:April 2007
Completion Date:July 2008
Completion Type:Actual
Primary Completion Date:July 2008
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 4, 2011
First Received Date:January 2, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:"on" time without dyskinesia
Time Frame:48 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Safety and tolerability data as measured by adverse events, electrocardiograms, physical exams, clinical laboratories tests, and vital signs
Time Frame:48 hours
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:pharmacokinetic data for investigational study drug
Time Frame:48 hours
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:piclozotan
Description:piclozotan, IV
Arm Name:piclozotan
Intervention Type:Drug
Name:0.9% sodium chloride (normal saline)
Description:0.9% sodium chloride (normal saline)
Arm Name:0.9 % sodium chloride (normal saline)

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:0.9 % sodium chloride (normal saline)
Study Arm Type:Active Comparator
Arm Name:piclozotan

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Asubio Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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