FindTrial
Sign In

A dose-finding study for SPM 962 in advanced Parkinson's disease patients with L-dopa adjunct therapy

A dose-finding study for SPM 962 in advanced Parkinson's disease patients with L-dopa adjunct therapy

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220282
Enrollment
Unknown
Registered
2006-07-27
Start date
2006-07-27
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

Idiopathic Parkinson's disease

Interventions

investigational material(s) Generic name etc : SPM 962 INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subject diagnosed as having Parkinson's disease in accordance with "Diagnostic Criteria established by the Research Committee of MHW-specified Intractable Neurodegenerative Diseases (1995)" 2. Aged over 30 years and less than 80 years at the time of informed consent 3. Hoehn & Yahr stage II - IV (on time) 4. Total UPDRS Part III score is over 10 at screening test (on time) 5. Subject is on a stable dose of L-dopa with no change in daily dose or dosing regimen for at least 28 days prior to the initial treatment of SPM 962 6. Subject has any of the following problematic symptoms 1) Wearing off phenomenon 2) On and off phenomenon 3) Delayed-on and/or No-on phenomenon 4) Not well controlled with L-dopa due to adverse effect 5) Weakening of L-dopa efficacy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy, Safety—

Outcome results

None listed

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