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

Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients with Parkinson's Disease)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220981
Enrollment
Unknown
Registered
2010-01-27
Start date
2010-01-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

investigational material(s) Generic name etc : KW-6500 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients who have given written informed consent - Patients who have completed the 6500-004 study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Safety: adverse events and related adverse events Efficacy: 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—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026