Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Intra-Cellular Therapies, Inc.
Study ID
NCT05766813
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenrispodun — DRUG
    Lenrispodun 30 mg tablets administered orally, once daily.
  • Placebo — DRUG
    Matching tablets administered orally, once daily.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.

Key Dates

First listed
Mar 13, 2023
Start date
Mar 13, 2023
Status verified
May 2026
Primary completion
Oct 28, 2025
Completion
Nov 4, 2025

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenrispodun 30 mg
    Lenrispodun 30 mg tablets administered orally, once-daily.
  • Placebo Comparator: Placebo
    Matching tablets administered orally, once daily.

Primary Outcome Measure

Hauser Diary [ Time Frame: Day 29 ]

Locations (35)

FacilityCityStateZIPSite coordinators
Clinical SitePhoenixArizona85013-
Clinical SiteScottsdaleArizona85251-
Clinical SiteIrvineCalifornia92697-
Clinical SiteLoma LindaCalifornia92354-
Clinical SiteAltamonte SpringsFlorida32714-
Clinical SiteBoca RatonFlorida33486-
Clinical SiteCoral SpringsFlorida33067-
Clinical SiteDoralFlorida33178-
Clinical SiteHallandaleFlorida33009-
Clinical SiteMaitlandFlorida32751-
Clinical SiteMiamiFlorida33136-
Clinical SiteOcalaFlorida34470-
Clinical SiteOrlandoFlorida32804-
Clinical SiteOrlandoFlorida32825-
Clinical SitePort OrangeFlorida32127-
Clinical SiteTampaFlorida33612-
Clinical SiteAugustaGeorgia30912-
Clinical SiteDecaturGeorgia30030-
Clinical SiteKansas CityKansas66160-
Clinical SiteFarmington HillsMichigan48334-
Clinical SiteGolden ValleyMinnesota55427-
Clinical SiteAlbanyNew York12208-
Clinical SiteRock HillSouth Carolina29732-
Clinical SiteFranklinTennessee37067-
Clinical SiteMemphisTennessee38157-
Clinical SiteAustinTexas78746-
Clinical SiteDallasTexas75243-
Clinical SiteGeorgetownTexas78628-
Clinical SiteAlexandriaVirginia22311-
Clinical SiteFalls ChurchVirginia22042-
Clinical SiteHenricoVirginia23233-
Clinical SiteKirklandWashington98034-
Clinical SiteSpokaneWashington99202-
Clinical SiteCrab OrchardWest Virginia25827-
Clinical SiteMilwaukeeWisconsin53226-

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