Idiopathic HypersomniaPhase 1NCT04091438
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
A Phase 1 study testing TAK-925 in people with Idiopathic Hypersomnia, run by Millennium Pharmaceuticals, Inc. at 22 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Hypersomnia
- What is being tested?
- TAK-925
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 26 Jan 2020to 23 Nov 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3 (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep latency test (MSLT) study performed within the last 10 years.
- Onset of hypersomnia between 10 and 30 years of age.
- Seven consecutive days of actigraphy supported by a sleep diary obtained prior to the nPSG (Study Day -2) shows an average nightly sleep duration of greater than or equal to (>=) 420 minutes during the participant's normal nocturnal sleep period.
- nPSG (Study Day -2) demonstrates that participant does not have other comorbid sleep disorders or clinically significant nocturnal hypoxemia (oxygen saturation ≤80% for ≥5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or equal to (<=) 10 per hour, their periodic limb movement arousal index (PLMAI) <=15/hour, and that their total sleep time is >=6.5 hours.
- Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
- Body mass index (BMI) of 18 through 33 kilogram per square meter (kg/m^2) inclusive.
- Epworth Sleepiness Scale (ESS) score >=11 at screening and on Day -2.
- Blood pressure (BP) must be <140 mmHg (systolic) and <90 mmHg (diastolic) at screening and Study Day -2.
Who cannot join
- Average nightly sleep duration is <=8 hours (480 minutes) and has insufficient sleep syndrome as evidenced by sleeping >2 hours/night more on "off-days" relative to "work days" as determined by actigraphy and sleep diary obtained prior to the nPSG (Study Day -2).
- Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
- Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off stimulants.
- Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method >450 ms (men) or >470 ms (women).
- Usual bedtime later than 24:00 (midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months, or travel with significant jet lag within 14 days before Study Day -2.
- History of a sleep disorder other than IH, based on interviews at the screening visit, such as obstructive sleep apnea (OSA), restless legs syndrome, or periodic limb movements of sleep (PLMS) associated with arousals.
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- Use of any over-the-counter (OTC) or prescription medications with stimulating properties within 7 days prior to dosing or 5 half-lives (whichever is longer) that could affect the evaluation of EDS or use of sodium oxybate within 3 months of screening.
- Nicotine dependence that is likely to have an effect on sleep (e.g., a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portion of the study (Day -2 to Day 4).
- Caffeine consumption of more than 600 mg/day for 7 days before Study Day 1 (1 serving of coffee is approximately equivalent to 120 mg of caffeine) and/or unwilling to discontinue all caffeine during the confinement portion of the study (Day -2 to Day 4).
- Alcohol use that is likely to have an effect on sleep and/or an unwillingness to discontinue all alcohol use from 72 hours before check-in through discharge on Study Day 4.
- History of epilepsy or seizures, including having had a single seizure or a history of childhood febrile seizures or has a clinically significant history of head trauma.
- Answered "YES" on Questions 4 or 5 on the Suicidal Ideation subscale of the Columbia Suicide Severity Rating Scale (C-SSRS) at screening (defined period as 3 months prior to screening) or evidence of suicidal behavior within 6 months of screening as measured by the Suicidal Behavior subscale of the C-SSRS.
- Diagnosis of major depressive disorder (DSM-5), within the past 6 months or Beck Depression Inventory II (BDI-II) total score of >16 at the screening visit.
- History of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
- Known coronary artery disease, a history of myocardial infarction, angina, cardiac rhythm abnormality, or heart failure.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States20 sites
Wright Clinical Research
Alabaster, Alabama, 35007
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342
Alpine Clinical Research Center
Boulder, Colorado, 80301
Helene A. Emsellem, MD PC trading as "The Center for Sleep & Wake Disorders"
Chevy Chase, Maryland, 20815
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
St Francis Medical Institute
Clearwater, Florida, 33765
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Pulmonary Associates Clinical Trials
Glendale, Arizona, 85306
MD Clinical
Hallandale, Florida, 33009
Research Centers of America
Hollywood, Florida, 33024
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, 34741
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Stanford School of Medicine
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Pacific Research Network, Inc
San Diego, California, 92103
Global Research Associates
Stockbridge, Georgia, 30281
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, 32789
Japan2 sites
SOUSEIKAI PS Clinic
Hakata-ku, Fukuoka, 812-0025
Sumida Hospital
Sumida-ku, Tokyo-To, 130-0004
About this study
Official title: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia
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).
Read the detailed description
The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH.
The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below:
- TAK-925 + Placebo
- Placebo + TAK-925
On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.
The multicenter study will be conducted in the United States and Japan. The overall duration of treatment in this study is approximately 41 days including screening up to 28 days, confinement for 6 days and end of study follow up telephone call on Study Day 11.
- Conditions
- Idiopathic Hypersomnia
- Being tested
- TAK-925, TAK-925 Placebo
- Keywords
- Drug therapy
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-925Drug
TAK-925 IV infusion.
TAK-925 PlaceboDrug
TAK-925 placebo-matching IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| TAK-925 Dose A + Placebo | Experimental | 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. Receives: Drug: TAK-925; Drug: TAK-925 Placebo |
| Placebo + TAK-925 Dose A | Placebo comparator | 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. Receives: Drug: TAK-925; Drug: TAK-925 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Measured: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests
Measured: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Measured: From Predose up to Study Day 4
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
Measured: Study Day 1 up to Study Day 4
Secondary outcomes (3)
Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
Measured: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925
Measured: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925
Measured: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start26 Jan 2020
- Primary completion19 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic HypersomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091438
- Sponsor's protocol ID
- TAK-925-2002
- Other IDs
- U1111-1238-3314, JapicCTI-195087
- Status last verified
- Nov 2022
- First submitted
- 13 Sep 2019
- Last updated
- 26 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Mignot E, Bogan RK, Emsellem H, Foldvary-Schaefer N, Naylor M, Neuwirth R, Faessel H, Swick T, Olsson T. Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia. Sleep. 2023 Sep 8;46(9):zsad049. doi: 10.1093/sleep/zsad049.
PubMed 36883238
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia
- ClinicalTrials.gov ID
- NCT04091438
- Acronym / sponsor ID
- TAK-925-2002
- Conditions
- Idiopathic Hypersomnia
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 26 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH.
The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below:
- TAK-925 + Placebo
- Placebo + TAK-925
On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion.
The multicenter study will be conducted in the United States and Japan. The overall duration of treatment in this study is approximately 41 days including screening up to 28 days, confinement for 6 days and end of study follow up telephone call on Study Day 11.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-925 Dose A + Placebo | Experimental | Drug: TAK-925, Drug: TAK-925 PlaceboTAK-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. |
| Placebo + TAK-925 Dose A | Placebo comparator | Drug: TAK-925, Drug: TAK-925 PlaceboTAK-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of IH, as defined by the International Classification of Sleep Disorders-3 (ICSD-3) as verified by a previous nocturnal polysomnography (nPSG) and multiple sleep latency test (MSLT) study performed within the last 10 years.
- Onset of hypersomnia between 10 and 30 years of age.
- Seven consecutive days of actigraphy supported by a sleep diary obtained prior to the nPSG (Study Day -2) shows an average nightly sleep duration of greater than or equal to (>=) 420 minutes during the participant's normal nocturnal sleep period.
- nPSG (Study Day -2) demonstrates that participant does not have other comorbid sleep disorders or clinically significant nocturnal hypoxemia (oxygen saturation ≤80% for ≥5% of total sleep time) and that their Apnea-Hypopnea Index (AHI) is less than or equal to (<=) 10 per hour, their periodic limb movement arousal index (PLMAI) <=15/hour, and that their total sleep time is >=6.5 hours.
- Participants taking medication for treatment of excessive daytime sleepiness (EDS) must be willing to discontinue medication prior to randomization into the study.
Key exclusion criteria (15 listed)
- Average nightly sleep duration is <=8 hours (480 minutes) and has insufficient sleep syndrome as evidenced by sleeping >2 hours/night more on "off-days" relative to "work days" as determined by actigraphy and sleep diary obtained prior to the nPSG (Study Day -2).
- Positive urine screen for drugs of abuse and/or positive alcohol test at screening and Study Day -2.
- Resting heart rate (HR) outside of the range of 40 to 90 beats pper minute (bpm) off stimulants.
- Screening electrocardiogram (ECG) reveals a QT interval with Fridericia correction method >450 ms (men) or >470 ms (women).
- Usual bedtime later than 24:00 (midnight) or an occupation requiring nighttime shift work or variable shift work within the past 6 months, or travel with significant jet lag within 14 days before Study Day -2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-925TAK-925 IV infusion. | Drug | Placebo + TAK-925 Dose A, TAK-925 Dose A + Placebo |
| TAK-925 PlaceboTAK-925 placebo-matching IV infusion. | Drug | Placebo + TAK-925 Dose A, TAK-925 Dose A + Placebo |
Primary outcome
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests
Time frame: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Time frame: From Predose up to Study Day 4
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
Time frame: Study Day 1 up to Study Day 4
3 secondary outcomes
Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36883238Mignot E, Bogan RK, Emsellem H, Foldvary-Schaefer N, Naylor M, Neuwirth R, Faessel H, Swick T, Olsson T. Safety and pharmacodynamics of a single infusion of danavorexton in adults with idiopathic hypersomnia. Sleep. 2023 Sep 8;46(9):zsad049. doi: 10.1093/sleep/zsad049.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-925 in people with Idiopathic Hypersomnia, run by Millennium Pharmaceuticals, Inc. at 22 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) (time frame: Study Day 1 up to Study Day 11). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091438, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.