A Study to Test the Safety and Effectiveness of TAK-360 in People with Narcolepsy without Cataplexy

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What is this study about?

This study is looking at a condition called Narcolepsy without Cataplexy, also known as NT2. This is a sleep disorder where people experience excessive daytime sleepiness and may suddenly fall asleep during the day, but they do not have sudden muscle weakness or loss of muscle control that can occur in other forms of narcolepsy. The treatment being tested is called TAK-360, which is an experimental medication given as a tablet by mouth. Some participants will receive TAK-360 while others will receive placebo. The purpose of this study is to evaluate the safety and tolerability of TAK-360.

During the study, participants will take TAK-360 or placebo for a period of 4 weeks. The study will look at whether any unwanted effects occur during treatment. The study will also measure changes in daytime sleepiness using a questionnaire called the Epworth Sleepiness Scale, which asks about how likely someone is to fall asleep in different situations. Additionally, a test called the Maintenance of Wakefulness Test will be used, which measures how well someone can stay awake in a quiet, comfortable setting. These measurements will be compared between the group taking TAK-360 and the group taking placebo to see if there are any differences.

Participants in this study will be adults between 18 and 70 years old who have been diagnosed with NT2. The study uses a design where neither the participants nor the doctors know who is receiving the actual medication and who is receiving placebo until the study is completed. This helps ensure that the results are measured fairly and without bias. The study will continue for several weeks and will involve regular visits to check on safety and how well the treatment is working.

1 Treatment period with study medication

During this phase, you will receive either TAK-360 or placebo (a tablet that looks identical but contains no active medication). The assignment will be random, and neither you nor the medical staff will know which one you are receiving.

You will take the medication by mouth in the form of tablets.

This treatment period will last for 4 weeks.

2 Baseline assessments

At the beginning of the study, measurements will be taken to establish your starting point. These baseline values will be used for comparison with later results.

Your level of daytime sleepiness will be assessed using the Epworth Sleepiness Scale, which is a questionnaire that measures how likely you are to fall asleep in different situations.

Your ability to stay awake will be measured using the Maintenance of Wakefulness Test, which records how long you can remain awake in a quiet, comfortable setting.

3 Week 4 assessments

After 4 weeks of treatment, the same assessments will be repeated.

The Epworth Sleepiness Scale will be completed again to measure any changes in your daytime sleepiness compared to the baseline.

The Maintenance of Wakefulness Test will be performed again to measure any changes in your ability to stay awake compared to the baseline.

4 Safety monitoring throughout the study

Throughout the entire study period, you will be monitored for any side effects or adverse events.

Any health problems or symptoms that occur during the trial will be recorded and evaluated by the medical team.

This monitoring is done to assess the safety and tolerability of the study medication.

Who Can Join the Study?

  • You must be between 18 and 70 years old at the time of signing the consent form
  • You must weigh at least 40 kilograms
  • Your body mass index (a number calculated from your weight and height) must be between 16 and 38
  • You must have a confirmed current diagnosis of narcolepsy without cataplexy, which is a sleep disorder that causes excessive daytime sleepiness without sudden muscle weakness

Who Cannot Join the Study?

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria listed, it is not possible to specify which medical conditions, medications, or other factors would prevent someone from joining this clinical trial
  • Typically, exclusion criteria may include things like other serious health problems, use of certain medications, pregnancy, or recent participation in other studies, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Hopital Beaujon Clichy France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
11.12.2025
Italy Italy
Recruiting
11.12.2025
Spain Spain
Recruiting
11.12.2025

Trial locations

TAK-360 is an investigational medication being studied for the treatment of narcolepsy without cataplexy. This is an experimental drug that is being tested to see if it is safe and effective for people who have narcolepsy but do not experience cataplexy, which is a sudden loss of muscle control. The trial will look at different amounts of this medication to find the best dose that works well and is safe for patients to take.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against TAK-360 to help researchers understand if the actual medication is working better than no treatment at all.

Investigated diseases:

Narcolepsy without Cataplexy – This is a chronic sleep disorder characterized by excessive daytime sleepiness and sudden, uncontrollable episodes of falling asleep during the day. People with this condition experience overwhelming drowsiness and may fall asleep at inappropriate times, such as during work or conversations. Unlike narcolepsy with cataplexy, individuals with this form do not experience sudden loss of muscle tone triggered by emotions. The disorder disrupts the normal sleep-wake cycle, making it difficult to maintain alertness throughout the day. Nighttime sleep is often fragmented and disturbed, though the person sleeps for normal or extended periods. This condition significantly impacts daily functioning, work performance, and social activities.

Trial ID:
2024-517711-70-01
Protocol code:
TAK-360-2001
NCT ID:
NCT06952699
Trial Phase:
Therapeutic exploratory (Phase II)

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