NCT01063621

Brief Summary

This is a extended long-term safety study in Parkinson's disease patients who have motor response complications on levodopa therapy and completed 12 weeks administrations of KW-6500 in 6500-004 study. The safety and efficacy of long-term subcutaneous self-injections of KW-6500 are evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.6 years

First QC Date

February 4, 2010

Last Update Submit

March 14, 2017

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Adverse events and related adverse events

    From first administration of study drug through Study Week 52

Secondary Outcomes (1)

  • Time to expression of the ON state, continuous time of the ON state, raw score change and percent score change in UPDRS part III, response ratio, and UPDRS part II score

    From first administration of study drug through Study Week 52

Study Arms (1)

KW-6500

EXPERIMENTAL
Drug: KW-6500

Interventions

KW-6500DRUG

Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks

Also known as: Apomorphine hydroshloride (USAN)
KW-6500

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have given written informed consent
  • Patients who have completed the 6500-004 study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tōon, Ehime, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 5, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

March 1, 2012

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

JP(1)