A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Takeda
Study ID
NCT05816382
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Narcolepsy Type 1

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TAK-861 — DRUG
    TAK-861 tablets

Study Details

The main aim is to evaluate the safety and tolerability of TAK-861 in participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.

Key Dates

Start date
Apr 5, 2023
Status verified
Mar 2026
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAK-861
    In this trial, all participants are on TAK-861 treatment and they can switch to one of the available doses as needed.

Primary Outcome Measure

Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years) ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Sleep Disorders Center of AlabamaBirminghamAlabama35213-
Stanford Center for Sleep Sciences and MedicineRedwood CityCalifornia94063-
SDS Clinical Trials, Inc.Santa AnaCalifornia92705-
Delta Waves LLC - Hunt - PPDSColorado SpringsColorado80918-
Florida Pediatric Research InstituteOrlandoFlorida32803-
Neurotrials ResearchAtlantaGeorgia30342-
Georgia Neuro CenterGainesvilleGeorgia30501-
Neurocare IncNewtonMassachusetts02459-
Henry Ford Medical Center - ColumbusNoviMichigan48377-
Research Carolina EliteDenverNorth Carolina28037-
ARSM Research, LLCHuntersvilleNorth Carolina28078-
CTI Research CenterCincinnatiOhio45212-
Intrepid ResearchCincinnatiOhio45227-
The Cleveland Clinic FoundationClevelandOhio44195-
Ohio Sleep Medicine InstituteDublinOhio43017-
Medical University of South Carolina - PPDSCharlestonSouth Carolina29425-
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201-
Sleep Therapy and Research CenterSan AntonioTexas78229-
Children's Specialty GroupNorfolkVirginia23510-

Find similar trials in Birmingham, AL

By research site
Sleep Disorders Center of Alabama· Birmingham, ALStanford Center for Sleep Sciences and Medicine· Redwood City, CASDS Clinical Trials, Inc.· Santa Ana, CADelta Waves LLC - Hunt - PPDS· Colorado Springs, COFlorida Pediatric Research Institute· Orlando, FLNeurotrials Research· Atlanta, GA

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