A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Annovis Bio Inc.
Study ID
NCT05357989
Phase
PHASE3
Status
Completed

Conditions

  • Parkinson's Disease, Idiopathic

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • buntanetap/posiphen — DRUG
    HPMC (vegetarian source) capsule shells
  • Placebo — DRUG
    HPMC (vegetarian source) capsule shells

Study Details

The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD. Study details include: * The study duration will be up to 7-8 months. * The double-blind treatment duration will be up to 6 months. * There will be 5 in-clinic visits and 7 phone calls

Key Dates

Start date
Aug 3, 2022
Status verified
Feb 2025
Primary completion
Dec 4, 2023
Completion
Dec 4, 2023

Study Design

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

Arms

  • Experimental: 10 mg buntanetap/posiphen
    Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months
  • Experimental: 20 mg buntanetap/posiphen
    Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months
  • Placebo Comparator: Placebo
    Placebo oral capsule with daily administration for a period of 6 months

Primary Outcome Measure

Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state) [ Time Frame: Baseline and 6 months visits ]

Locations (43)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB)- The Kirklin ClinicBirminghamAlabama35233-2110-
Banner Sun Health Research Institute - Cleo Roberts Center for Clinical ResearchSun CityArizona85351-3020-
Parkinson's & Movement Disorder Institue (PMDI) - Orange County OfficeFountain ValleyCalifornia92708-
UCSF Medical Center - Parkinson's Disease and Movement Disorders ClinicSan FranciscoCalifornia94143-2202-
Rocky Mountain Movement Disorder CenterEnglewoodColorado80113-
Ki Health Partners LLC D/B/A New England Institute for Clinical ResearchStamfordConnecticut06824-
Visionary Investigators NetworkAventuraFlorida33180-
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca RatonFlorida33486-2359-
The Neurology Institute - Coral SpringsCoral SpringsFlorida33067-4640-
Arrow Clinical trialDaytona BeachFlorida32114-
Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720-
Coral Clinic Reserach LLCHomesteadFlorida33032-
Ezy Medical Research Co.MiamiFlorida33175-
Homestead Associates in Research, IncMiamiFlorida33032-
Medical Professional Clinical Research Center, INCMiamiFlorida33165-
Reliant Medical ResearchMiamiFlorida33165-
Visionary Investigators NetworkMiamiFlorida33176-
Visionary Investigators NetworksMiamiFlorida33133-
Renstar Medical ResearchOcalaFlorida34470-
Visionary Investigators NetworkPembroke PinesFlorida33026-
Parkinsons Disease Treatment CenterPort CharlotteFlorida33952-6705-
University of South Florida (USF) - University of South Florida College of Medicine- Parkinson's Disease and Movement Disorders CenterTampaFlorida33613-4808-
ClinCloud, LLCVieraFlorida32940-
Conquest Research, LLCWinter ParkFlorida32789-
CenExel iResearch, LLCDecaturGeorgia30030-
Hawaii Pacific Neuroscience, LLCHonoluluHawaii96817-
Josephson Wallack Munshower Neurology, P.C.IndianapolisIndiana46256-
University of Kansas Medical CenterKansas CityKansas66160-
Michigan State University (MSU)- Health Team- Neurology and Ophthalmology ClinicEast LansingMichigan48824-7037-
Quest Research InstitueFarmington HillsMichigan48334-
Parkinson's Disease and Movement Disorders Center of Long IslandCommackNew York11725-3400-
Mount Sinai West (Mount Sinai Roosevelt)New YorkNew York10019-1147-
Ohio State University Wexner Medical Center (OSUWMC) - CarePoint GahannaColumbusOhio43211-
The Movement Disorder Clinic (MDC) of OklahomaTulsaOklahoma74136-6372-
Abington NeurologyAbingtonPennsylvania19001-
University of PennsylvaniaPhiladelphiaPennsylvania19107-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South Carolina (MUSC) - The Murray Center for Research on Parkinson's Disease and Related DisordersCharlestonSouth Carolina29401-1189-
Veracity Neuroscience, LLCMemphisTennessee38157-
Central Texas Neurology ConsultantsRound RockTexas78681-
University of Virginia Health System (UVAHS)- Adult Neurology ClinicCharlottesvilleVirginia22903-
Inland Northwest ResearchSpokaneWashington99202-1342-
Medical College of WisconsinMilwaukeeWisconsin53226-

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Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB)- The Kirklin Clinic· Birmingham, ALBanner Sun Health Research Institute - Cleo Roberts Center for Clinical Research· Sun City, AZParkinson's & Movement Disorder Institue (PMDI) - Orange County Office· Fountain Valley, CAUCSF Medical Center - Parkinson's Disease and Movement Disorders Clinic· San Francisco, CARocky Mountain Movement Disorder Center· Englewood, COKi Health Partners LLC D/B/A New England Institute for Clinical Research· Stamford, CT