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TAK-925 for Idiopathic Hypersomnia

Phase 1
Waitlist Available
Research Sponsored by Millennium Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).

Eligible Conditions
  • Idiopathic Hypersomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TAK-925 Dose A + PlaceboExperimental Treatment2 Interventions
TAK-925 112 milligram (mg), 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by TAK-925 placebo-matching 9-hour intravenous infusion once on Day 3, Treatment Period 2.
Group II: Placebo + TAK-925 Dose APlacebo Group2 Interventions
TAK-925 placebo-matching 9-hour intravenous infusion once on Day 1, Treatment Period 1 followed by 24 hours wash-out period, followed by, TAK-925 112 mg, 9-hour intravenous infusion once on Day 3, Treatment Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-925
2017
Completed Phase 1
~190
TAK-925 Placebo
2020
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Millennium Pharmaceuticals, Inc.Lead Sponsor
404 Previous Clinical Trials
46,886 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,266 Previous Clinical Trials
503,888 Total Patients Enrolled
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
63,201 Total Patients Enrolled
~5 spots leftby Oct 2025
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