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Narcolepsy clinical trials

View clinical trials related to Narcolepsy.

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NCT ID: NCT05914194 Not yet recruiting - Narcolepsy Type 1 Clinical Trials

A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1

AMAZE
Start date: January 15, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to see how NLS-2 (mazindol extended-release) works on symptoms of narcolepsy, including cataplexy and excessive daytime sleepiness. Approximately 48 participants will take part in the study across the United States. The study treatment (NLS-2 or placebo) will be administered for 8 weeks. After this treatment period, the participant may have the option to participate in a separate long-term extension study during which all participants will be treated with NLS-2.

NCT ID: NCT05884112 Recruiting - Narcolepsy Clinical Trials

Treating Comorbid Depression of Patients With Narcolepsy by Intermittent Theta Burst Stimulation

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

Narcolepsy is a chronic brain disorder. The mechanism is the impairment of brain controlling of sleep and wakefulness. The cause of this disease is still unclear, but common symptoms include excessive day time sleepiness, cataplexy, hypnogogic hallucination, sleep paralysis, and sleep disturbance. Because these symptoms are easily confused together in many situations, it is difficult for doctors to make the diagnosis. Therefore, medical treatment for patients is always delayed. According to previous research report, narcoleptic patients are often delay diagnosis for 10 to 15 years after the onset of the disease. Clearly, to make the diagnosis of narcolepsy is very difficult. Another cause for the delay is the method for diagnosing narcolepsy, which mainly rely on sleep examination instruments and the testing of hypocretin concentration in the cerebrospinal fluid. However, these tests are difficult to carry out in many areas, and diagnosing narcolepsy is still difficult in many countries. To the patients and their families, developing a fast and accurate method or tool for diagnosing narcolepsy is of the utmost importance.

NCT ID: NCT05875974 Recruiting - Narcolepsy Clinical Trials

Ph4 PSG Combined JZP258-407

Start date: July 27, 2023
Phase: Phase 4
Study type: Interventional

This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.

NCT ID: NCT05870735 Not yet recruiting - Narcolepsy Clinical Trials

Discovering Factors in Narcolepsy Patients' Clinical Research Experiences

Start date: June 2024
Phase:
Study type: Observational

An observational trial can provide a platform for patients to share experiences and perspectives on living with narcolepsy, which can inform the development of new treatments and support programs. Overall, an observational clinical trial is an important tool for advancing the understanding of narcolepsy and improving outcomes for patients.

NCT ID: NCT05869773 Recruiting - Narcolepsy Clinical Trials

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Start date: June 26, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.

NCT ID: NCT05816382 Recruiting - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Start date: April 5, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

NCT ID: NCT05773872 Recruiting - Narcolepsy Clinical Trials

Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia

COGNAR
Start date: March 7, 2023
Phase: N/A
Study type: Interventional

Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group. In a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved. A better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy. The protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.

NCT ID: NCT05709873 Active, not recruiting - Narcolepsy Clinical Trials

Narcolepsy Nightmare Study

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are: - Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares? - Does adding targeted dream control (TDC) to IRT make it more effective? Participants will be randomized to one of two treatment groups and will be asked to: - Complete a daily log of sleep symptoms for up to 13 weeks. - Attend 7 sessions of treatment. - Complete questionnaires before and after treatment. - Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).

NCT ID: NCT05687916 Active, not recruiting - Narcolepsy Type 2 Clinical Trials

A Study of TAK-861 in Participants With Narcolepsy Type 2

Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT). The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.

NCT ID: NCT05687903 Completed - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 in Participants With Narcolepsy Type 1

Start date: January 9, 2023
Phase: Phase 2
Study type: Interventional

The main aim of this study is to see how TAK-861 works on symptoms of narcolepsy, including excessive daytime sleepiness and cataplexy. Approximately 100 participants will take part in the study across North America, Europe and Asia Pacific. The treatment (TAK-861 or placebo) will be administered for 8 or 12 weeks. After this treatment period the participant will have the option to participate in a separate, long- term extension study during which all participants will be treated with TAK-861.