A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221162

Enrollment

360

Registered

2010-07-22

Start date

2010-07-22

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 : Zonisamide INN of investigational material : Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational mater

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Parkinson's disease who meet the following criteria - Patients who are effective in the treatment of L-DOPA single-agent or L-DOPA/DCI combination of drugs when initiated treatment - Patients who are taking L-DOPA/DCI combination of drugs continuously for more than 6 months - Patients who have developed the wearing-off phenomenon

Exclusion criteria

Exclusion criteria: - Patients with epilepsy - Patients who are taking L-DOPA single-agent - Patients with a history of treatment with zonisamide

Design outcomes

Primary

Measure	Time frame
Efficacy: Change from baseline in total daily "off" time	—

Secondary

Measure	Time frame
Efficacy: Change from baseline in UPDRS total score	—

Outcome results

None listed

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