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Extended Long-Term Safety Study of KW-6500 (6500-005)

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ClinicalTrials.gov Identifier: NCT01063621
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: KW-6500 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)
Study Start Date : January 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: KW-6500 Drug: KW-6500
Subcutaneous injection of 1 to 6 mg for the OFF state during 52 weeks
Other Name: Apomorphine hydroshloride (USAN)



Primary Outcome Measures :
  1. Adverse events and related adverse events [ Time Frame: From first administration of study drug through Study Week 52 ]

Secondary Outcome Measures :
  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 [ Time Frame: From first administration of study drug through Study Week 52 ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063621


Locations
Japan
Toon, Ehime, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01063621     History of Changes
Other Study ID Numbers: 6500-005
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases