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Narcolepsy – Trials in Disease

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Ongoing Clinical Trials for Narcolepsy

Currently, 8 clinical trials are underway across Europe to evaluate new treatments for narcolepsy, a chronic sleep disorder causing excessive daytime sleepiness and, in some cases, sudden muscle weakness (cataplexy). These studies investigate medications such as ALKS 2680, TAK-861, ORX750, pitolisant, and XYWAV, aiming to improve symptom management and quality of life for patients with narcolepsy Type 1 and Type 2.

Clinical trial locations

Long-Term Study on the Safety and Effects of ALKS 2680 for Patients with Narcolepsy Type 1 and Type 2

This study is evaluating the long-term safety and effectiveness of ALKS 2680 in patients with both Type 1 and Type 2 narcolepsy. ALKS 2680 is administered orally in tablet form.

Main inclusion criteria: To participate, patients must have a confirmed diagnosis of either Narcolepsy Type 1 or Type 2. They must have completed a previous study with ALKS 2680 and shown improvement in their symptoms. Participants need to be willing to provide informed consent and follow study requirements, including stopping other medications for excessive daytime sleepiness and cataplexy if required. Both male and female patients are eligible.

Main exclusion criteria: Patients with other sleep disorders besides narcolepsy cannot join. Those with severe allergic reactions to medications, significant heart problems, severe liver or kidney disease, or uncontrolled high blood pressure are excluded. Pregnant or breastfeeding women, individuals with recent drug or alcohol abuse, and those who participated in another trial within the last 30 days are not eligible.

Study focus: The trial monitors participants over several years to assess long-term safety, tolerability, and continued effectiveness. Regular assessments include vital signs, laboratory tests, electrocardiograms, and evaluations of sleepiness using the Epworth Sleepiness Scale and Maintenance of Wakefulness Test. For Type 1 participants, cataplexy frequency is also tracked. The study is expected to continue until December 2027.

Investigational drug: ALKS 2680 is being studied for its potential to reduce symptoms of excessive daytime sleepiness and improve quality of life in people with narcolepsy.

Study on the Long-term Safety of TAK-861 for Patients with Narcolepsy Type 1

This trial focuses specifically on Narcolepsy Type 1, evaluating the long-term safety and tolerability of TAK-861, an oral medication taken in tablet form.

Main inclusion criteria: Participants must have a diagnosis of Narcolepsy Type 1 with cataplexy and must have completed a previous controlled study with TAK-861. The study doctor must have no medical concerns about their participation. Both males and females across certain age groups are eligible.

Main exclusion criteria: The trial excludes patients with other sleep disorders, those currently taking interfering medications, and individuals with severe heart, liver, or kidney disease. Pregnant or breastfeeding women and those with recent substance abuse history are not eligible.

Study focus: The primary goal is to monitor treatment-emergent adverse events over an extended period, continuing until February 2028. Secondary evaluations include changes in sleep latency, scores on the Epworth Sleepiness Scale, and cataplexy occurrences recorded through patient diaries.

Investigational drug: TAK-861 is being tested to understand its safety profile and tolerability for long-term management of Narcolepsy Type 1 symptoms.

Study on the Safety and Effects of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia

This study evaluates ORX750, an oral capsule medication, for both narcolepsy and idiopathic hypersomnia, a related condition characterized by excessive sleepiness without a known cause.

Main inclusion criteria: Participants must be between 18 and 65 years old with a Body Mass Index between 17 and 37 kg/m². They must have a confirmed diagnosis of Narcolepsy Type 1, Type 2, or idiopathic hypersomnia according to medical guidelines. Participants need to be willing to stop all current medications for these conditions and follow additional study requirements.

Main exclusion criteria: People with other sleep disorders, those outside the specified age range, vulnerable populations unable to give informed consent, and those with medical conditions interfering with the study are excluded. Recent major surgery, pregnancy, breastfeeding, known allergies to the study medication, and current participation in another trial also disqualify candidates.

Study focus: The 28-day trial assesses safety and tolerability through regular check-ups, laboratory tests, and heart monitoring. The study measures medication effects on sleep patterns and daytime sleepiness. It is expected to conclude in November 2025.

Investigational drug: ORX750 is being investigated for its potential to improve alertness and reduce excessive sleepiness in patients with narcolepsy and idiopathic hypersomnia.

Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients

This is a randomized, double-blind study evaluating TAK-861 tablets for treating Narcolepsy Type 1 with cataplexy over a 12-week period.

Main inclusion criteria: Men and women aged 18-70 years with a Body Mass Index between 18 and 40 kg/m² can participate. They must have a confirmed diagnosis of Narcolepsy Type 1 and experience at least four cataplexy episodes per week. Participants must test positive for the HLA-DQB1*06:02 genetic marker or have low hypocretin-1 levels in their spinal fluid, and must be in good general health based on comprehensive medical evaluations.

Main exclusion criteria: Individuals with other sleep disorders, severe heart problems, or those taking medications affecting the central nervous system are excluded. Pregnant or breastfeeding women and those with recent substance abuse are not eligible.

Study focus: The trial measures how well TAK-861 reduces excessive daytime sleepiness using the Epworth Sleepiness Scale. It also evaluates changes in cataplexy frequency, sleep latency, and overall quality of life through regular assessments and monitoring.

Investigational drug: TAK-861 is designed to reduce daytime sleepiness by influencing specific neurotransmitters in the brain that regulate wakefulness.

Study on Blood Pressure Changes in Narcolepsy Patients Switching from High-Sodium Oxybate to JZP258 (Oxybate Mixed-Salt Formulation)

This trial examines how switching from high-sodium oxybate to XYWAV affects blood pressure in people with narcolepsy.

Main inclusion criteria: Participants aged 18-70 must have documented Narcolepsy Type 1 or Type 2 and have been taking high-sodium oxybate at 6-9 grams per night for at least six weeks. Their average systolic blood pressure should be between 130 and 155 mm Hg, with diastolic pressure not exceeding 95 mm Hg. Participants must maintain stable doses of any other medications, including stimulants and blood pressure treatments, unless advised otherwise by their doctor.

Main exclusion criteria: Those without a narcolepsy diagnosis, outside the age range, unable to switch medications, or with medical conditions interfering with the study cannot participate. Pregnant or breastfeeding women and those with substance abuse history are excluded.

Study focus: The study monitors blood pressure changes over 24 hours after switching to XYWAV, an oral solution containing a mix of sodium, calcium, magnesium, and potassium oxybate. Regular blood pressure monitoring helps determine if XYWAV offers benefits for blood pressure management while treating narcolepsy symptoms.

Investigational drug: XYWAV is being evaluated as an alternative formulation that may provide better blood pressure control compared to high-sodium oxybate while maintaining effectiveness for narcolepsy symptoms.

Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients

This is another 12-week randomized, double-blind trial of TAK-861 tablets for Narcolepsy Type 1 with cataplexy.

Main inclusion criteria: Male and female participants aged 18-70 with a BMI of 18-40 kg/m² are eligible. They must have confirmed Narcolepsy Type 1, experience at least four cataplexy episodes weekly, and test positive for HLA-DQB1*06:02 or have low hypocretin-1 levels. Good general health confirmed through medical evaluations is required.

Main exclusion criteria: Other sleep disorders, severe heart conditions, medications affecting the central nervous system, pregnancy, breastfeeding, and recent substance abuse disqualify participants.

Study focus: The trial evaluates TAK-861’s effectiveness in reducing excessive daytime sleepiness measured by the Epworth Sleepiness Scale. It also monitors cataplexy frequency, sleep latency, and quality of life through regular assessments throughout the 12-week period.

Investigational drug: TAK-861 is a central nervous system agent designed to promote wakefulness and reduce narcolepsy symptoms by modulating brain neurotransmitters.

Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 2

This eight-week trial specifically targets Narcolepsy Type 2, evaluating ALKS 2680 tablets through both double-blind and open-label periods.

Main inclusion criteria: Participants must be 18-70 years old with a BMI of 18-40 kg/m². They must have confirmed Narcolepsy Type 2 and be willing to stop current medications for narcolepsy symptoms for at least 14 days before starting the study. Participants must be able to follow study rules, including lifestyle guidelines, birth control use if needed, and maintaining a sleep diary. Those with obstructive sleep apnea must use their treatment regularly.

Main exclusion criteria: Individuals without Narcolepsy Type 2, those outside the age range, and vulnerable populations unable to give consent are excluded.

Study focus: The trial assesses safety and effectiveness of ALKS 2680 in managing excessive daytime sleepiness specific to Type 2 narcolepsy. The study uses a dose-range-finding approach, with participants randomly assigned to receive ALKS 2680 or placebo initially, followed by an open-label period where all receive the active medication. Monitoring includes Maintenance of Wakefulness Test scores, Epworth Sleepiness Scale assessments, and comprehensive safety evaluations.

Investigational drug: ALKS 2680 is being tested as a central nervous system stimulant to promote wakefulness and reduce sleepiness in Narcolepsy Type 2 patients.

Study on the Safety and Effectiveness of Pitolisant for Children Aged 6-17 with Narcolepsy, with or without Cataplexy

This eight-week trial is unique in focusing on children and adolescents, evaluating pitolisant film-coated tablets for narcolepsy with or without cataplexy.

Main inclusion criteria: Children aged 6 to less than 18 years with confirmed narcolepsy (with or without cataplexy) can participate. Diagnosis must be confirmed through polysomnography and Multiple Sleep Latency Test. Participants need a Pediatric Daytime Sleepiness Scale score of 15 or higher and must stop any non-approved medications, especially psychostimulants, from study start. Both the child and parents must provide informed consent, and participants need adequate support to follow study requirements. Female participants who have started puberty must use effective birth control during the study and for one month after treatment ends.

Main exclusion criteria: Children with other sleep disorders, severe allergic reactions to medications, significant heart problems, uncontrolled high blood pressure, severe liver or kidney disease, or recent trial participation are excluded. Pregnant or breastfeeding participants and those with drug or alcohol abuse history cannot join.

Study focus: The trial includes both double-blind and open-label periods, evaluating pitolisant’s ability to reduce daytime sleepiness and cataplexy episodes in children. Regular monitoring includes the Ullanlinna Narcolepsy Scale and Pediatric Daytime Sleepiness Scale assessments. The study tracks safety, tolerability, and symptom improvement throughout the treatment period.

Investigational drug: Pitolisant works by increasing histamine levels in the brain, which helps promote wakefulness and alertness. It is classified as a histamine H3 receptor antagonist/inverse agonist and represents an important treatment option being studied for pediatric narcolepsy.

Summary

These eight clinical trials represent a comprehensive effort to advance treatment options for narcolepsy across Europe. Several notable patterns emerge from this collection of studies. France, Italy, and Spain host the widest range of trials, with participation in nearly all available studies, indicating strong research infrastructure for sleep disorders in these countries. Belgium, the Netherlands, and Czechia also show significant involvement.

TAK-861 is the most frequently studied medication, appearing in four separate trials, all focusing on Narcolepsy Type 1 with cataplexy. This concentration of research suggests TAK-861 is a promising candidate for managing this specific form of the disorder. ALKS 2680 appears in three trials and is notable for being tested in both Type 1 and Type 2 narcolepsy, offering potential treatment options for a broader patient population.

The trials demonstrate diverse research approaches, from short 12-week efficacy studies to long-term safety evaluations extending to 2027-2028. One study takes a unique approach by examining the effects of switching from high-sodium oxybate to XYWAV, addressing both symptom management and blood pressure concerns. Particularly noteworthy is the pediatric trial of pitolisant, which specifically addresses the significant unmet need for safe, effective treatments for children and adolescents with narcolepsy.

These studies collectively aim to improve quality of life for people living with narcolepsy by exploring new medications, optimizing existing treatments, and establishing long-term safety profiles across different patient populations.

Ongoing Clinical Trials on Narcolepsy

  • Long-term Safety Study of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia Who Completed a Previous ORX750 Trial

    Recruiting

    1 1
    Investigated diseases:
    France Italy Spain

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

    Recruiting

    1
    Investigated diseases:
    France Italy Spain

  • Study on the Safety and Effects of ORX750 for Patients with Narcolepsy and Idiopathic Hypersomnia

    Recruiting

    1
    Investigated diseases:
    France Italy Spain

  • Long-Term Study on the Safety and Effects of ALKS 2680 for Patients with Narcolepsy Type 1 and Type 2

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy The Netherlands Spain

  • Study on the Long-term Safety of TAK-861 for Patients with Narcolepsy Type 1

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Finland France Germany Italy +5

  • Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark Finland France +5

  • Study on TAK-861 for Treating Narcolepsy with Cataplexy in Patients

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Norway Spain

  • A study testing the safety and how the body processes TAK-861 in children and teenagers aged 6 to 17 years with narcolepsy type 1

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study on the Safety and Effectiveness of ALKS 2680 for Patients with Narcolepsy Type 2

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy The Netherlands Spain

  • Study on Blood Pressure Changes in Narcolepsy Patients Switching from High-Sodium Oxybate to JZP258 (Oxybate Mixed-Salt Formulation)

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Italy Spain

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