Chula Vista, CANCT07646678Now EnrollingIRB Ready

Idiopathic Hypersomnia Clinical Trial in Chula Vista, CA

Access cutting-edge idiopathic hypersomnia treatment through this phase 2/3 clinical trial at a research site in Chula Vista. Study-provided care at no cost to qualified participants.

Sponsored by Takeda

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Expert Care in Chula Vista

Access idiopathic hypersomnia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related idiopathic hypersomnia treatment provided free

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Check if you qualify for this idiopathic hypersomnia clinical trial in Chula Vista, CA

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Why Participate?

  • No-Cost Study Care

  • Local to Chula Vista

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Chula Vista site if eligible
  4. 4Begin participation

About This Idiopathic Hypersomnia Study in Chula Vista

Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps. The study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety). Participants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing. The participants will have to visit the clinic multiple times during this study.

Sponsor: Takeda

Who Can Participate

Inclusion Criteria

Participant is willing and able to understand and fully comply with trial procedures and requirements.
Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures. Key

Exclusion Criteria

Participant has a positive pregnancy test or is lactating/breastfeeding.
Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
Participant has developed a new history of seizures.
Participant has experienced clinically significant head injury, per investigator opinion.
Participant has developed a history of cerebral ischemia, transient ischemic attack (less than \[\<\] 5 years ago), or cerebral haemorrhage.
Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
Participant has developed a history of cancer in the past 5 years.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Chula Vista?

Yes, this clinical trial (NCT07646678) has an active research site in Chula Vista, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Idiopathic Hypersomnia Treatment Options in Chula Vista, CA

If you're searching for idiopathic hypersomnia treatment options in Chula Vista, CA, this clinical trial (NCT07646678) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Chula Vista research site is actively enrolling participants for this phase 2/3 clinical trial. You'll receive care from experienced idiopathic hypersomnia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all idiopathic hypersomnia clinical trials near you to find additional studies recruiting in your area.

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