Trials Sponsors Conditions Drugs Pricing

Conditions

Parkinson's Disease

Keywords

dyskinesiamovement disordersbasal ganglia diseasesJP-1730Parkinsonend-of-dose wearing offfluctuations

Outcome Measures

Primary Outcomes (1)

To compare the efficacy of 3 different doses of fipamezole with that of placebo on dyskinesia as assessed by a dyskinesia assessment scale.
28-days treatment

Secondary Outcomes (1)

To compare efficacy of 3 different doses of fipamezole with that of placebo on the mean daily 'Off' time, as recorded in the patient diary.
28-days treatment

Study Arms (4)

1

PLACEBO COMPARATOR

One placebo tablet administered tid from Day 1 to 28

Drug: fipamezole

2

ACTIVE COMPARATOR

One 30-mg tablet of Fipamezole tid from Day 1 to 28

Drug: fipamezole

3

ACTIVE COMPARATOR

One 30-mg tablet of Fipamezole tid from Day 1 to 7; and one 60-mg tablet of Fipamezole tid from Day 8 to 28

Drug: fipamezole

Interventions

fipamezoleDrug

Fipamezole in Zydis formulation three times per day for up to 28 days

Also known as: JP-1730

1234

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Idiopathic Parkinson's disease.
Levodopa/DDI associated peak-dose dyskinesia which is at least moderately disabling and present for ≥25% of the waking day (UPDRS part IV, items 32 and 33, each ≥ 2).

Sponsors & Collaborators

Juvantia Pharma Ltd
Industrylead
Santhera Pharmaceuticals
Industrycollaborator

Study Sites (36)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Neurology Clinic PC

Northport, Alabama, 35476, United States

University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5023, United States

Parkinson and Movement Disorder Institute

Fountain Valley, California, 92708, United States

University of California Irvine

Irvine, California, 92697, United States

Coastal Neurological Medicine Group

La Jolla, California, 92037, United States

Colorado Neurological Institute

MeSH Terms

Conditions

Parkinson DiseaseDyskinesiasMovement DisordersBasal Ganglia Diseases

Interventions

fipamezole

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Peter A. LeWitt, M.D.
Henry Ford Health Systems, Franklin Pointe Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

180 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's Disease

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (36)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (36)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

4

You may not qualify if:

Source record

Locations