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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT01063621
First received: February 4, 2010
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Parkinson's Disease
Drug: KW-6500
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063621

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

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT01063621     History of Changes
Other Study ID Numbers: 6500-005
Study First Received: February 4, 2010
Last Updated: March 14, 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

ClinicalTrials.gov processed this record on April 28, 2017