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283PD201 (LUMA): A Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of BIIB122 in participants with Parkinson’s Disease

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505645-12-00
Acronym
283PD201
Enrollment
311
Registered
2024-06-12
Start date
2022-11-28
Completion date
Unknown
Last updated
2026-01-09

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

Conditions

Parkinson's Disease

Brief summary

Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.

Detailed description

Incidence of AEs and SAEs during the treatment period, Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period, Change in MDS-UPDRS Parts II and III combined score, Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period, Change in MDS-UPDRS Parts I, II, and III combined score

Interventions

Sponsors

Biogen Idec Research Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time to confirmed worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III combined score over the treatment period.

Secondary

MeasureTime frame
Incidence of AEs and SAEs during the treatment period, Time to confirmed worsening in MDS-UPDRS Part II score over the treatment period, Change in MDS-UPDRS Parts II and III combined score, Time to confirmed worsening in Schwab and England Activities of Daily Living Scale (SEADL) over the treatment period, Change in MDS-UPDRS Parts I, II, and III combined score

Countries

Austria, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026