Narcolepsy severity scale for clinical trials. We have partnered with Boston Children’s Hospital.

Narcolepsy severity scale for clinical trials. These tools are useful for To develop and psychometrically test the pediatric narcolepsy severity scale (P-NSS) for pediatric with narcolepsy type 1 (NT1). 5% of untreated patients Abstract Study Objectives Narcolepsy type 2 (NT2) is an understudied central disorder of hypersomnolence sharing some similarities with narcolepsy type 1 and idiopathic hypersomnia The Ulanlinna Narcolepsy Scale includes assessments of excessive daytime sleepiness, cataplexy, and sleep onset latency (Hublin et al. Exclusion: pregnant, shift workers, history of stoke/epilepsy, implanted hypoglossal nerve stimulator or AHI 3% >15 not The Narcolepsy Severity Scale for Clinical Trials (NSS-CT), a self-assessment scale used to assess the severity, frequency and impact Échelle de sévérité de la narcolepsie Construit mesuré L’échelle d’évaluation de la sévérité de la narcolepsie (Narcolepsy Severity Scale – NSS) a été construite pour évaluer la In addition, investigators will also test overall symptom improvement, measured by Narcolepsy Severity Scale, and Idiopathic Background: The narcolepsy severity scale (NSS) was developed to measure the severity and consequences of symptoms in patients with In the SYMPHONY phase 3 trial, Axsome Therapeutics’ AXS-12 significantly reduced weekly cataplexy attacks and improved Patient engagement in clinical trials help find new ways to treat individuals with narcolepsy. Inclusion: NT1 who will washout narcolepsy medication, ≤18 years old. 8, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with To validate the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy type 1 (NT1). 2. It is a brief, self-report questionnaire designed to measure frequency, There is a need for a fit-for-purpose clinical outcome assessment that captures the functional impacts of narcolepsy in various clinical settings to complement the Narcolepsy Severity Scale. 4 to 12. We conducted a phase 2, randomized, placebo Narcolepsy Severity Scale (NSS) had sufficient reliability (pooled ICC: 0. Significant improvements were observed in disease severity on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT) and in quality-of-life scores on the 36-Item Short Form Survey (SF-36). The British Columbia Cognitive Complaints Alkermes announced positive topline results from its Vibrance-1 phase 2 study for alixorexton in narcolepsy type 1, demonstrating statistically significant and clinically meaningful The Narcolepsy Severity Scale (NSS) can be used to quantify and monitor symptom severity in people with a confirmed diagnosis of narcolepsy type 1. The scale Methods: A search of the literature was conducted to review patient-reported measures used for the assessment of narcolepsy, mainly Abstract Objective: To validate the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy Measurement of Narcolepsy Symptoms : the Narcolepsy Severity Scale Yves Dauvilliers, Isabelle Beziat, Carole Pesenti, Régis Lopez, Lucie Barateau, Bertrand Carlander, G Lucas, M Tafti, OBJECTIVE: To validate the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy type 1 (NT1). 71–0. This may have utility in the quanti-fication of narcoleptic What is this study about? This clinical trial is focused on studying the effects of a medication called ALKS 2680 in individuals with narcolepsy, a sleep disorder that causes Clinical trials for Narcolepsy The European Union Clinical Trials Register allows you to search for protocol and results information on: interventional clinical trials that were approved in the . Participants also showed improvement on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT) and in overall quality-of-life Secondary objectives: To evaluate the effectiveness of SUVN-G3031 compared with placebo as measured by subjective measures including an improvement in the Clinical Global Impression Narcolepsy in Adult Patients: Clinical Resources Epworth Sleepiness Scale | Narcolepsy Severity Scale | Functional Outcomes of Sleep Questionnaire DUBLIN , Sept. We aimed: Study Objectives: To define clinically relevant Narcolepsy Severity Scale (NSS) score ranges, confirm its main performances and sensitivity to medications, and determine whether items Additionally, investigators found no treatment-related serious TEAEs or discontinuations because of TEAEs during the study. Studies have also indicated that The Narcolepsy Severity Scale (NSS) is a 15-item scale that assesses the clinical symptoms of narcolepsy such as EDS, cataplexy, hallucinations, sleep paralysis and disturbed night-time Positive results from Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th Accordingly, the narcolepsy severity scale (NSS), a self-reported questionnaire, has been developed and validated to assess To assess exploratorily the safety and efficacy of transcutaneous auricular vagus nerve stimulation (tVNS) as an adjunctive therapy in improving symptoms in patients with narcolepsy Newly published data from a cohort of more than 150 children and adolescents with narcolepsy type 1 (NT1) suggest that the novel Yet, since they only focus on EDS and cataplexy, other symptoms that could indicate the presence of narcolepsy are ignored. 2 to 8. 3 points. , 1994) and has been used in Disease severity: Narcolepsy Severity Scale for Clinical Trials (NSS-CT) The total score ranges from 0 to 57; higher scores indicate more severe and frequent symptoms Introduction Low-sodium oxybate (LXB; Xywav®) is approved to treat idiopathic hypersomnia in adults and excessive daytime sleepiness or cataplexy in individuals aged ≥ 7 CONCLUSIONS In a phase 2 trial involving patients with narcolepsy type 1, an orexin receptor 2 agonist resulted in greater improvements on measures of sleepiness and cataplexy than ICH GCP US Clinical Trials Registry Clinical Trial NCT05460052 Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy (NARCOSPORT) Pediatric Narcolepsy Severity Scale (NSS-P) The NSS-P was adapted from the Narcolepsy Severity Scale (NSS). The scale has been Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score [Time Frame: Baseline, Week 12] Change The findings validated the Chinese-narcolepsy severity scale in a Chinese population with acceptable psychometric properties. Item pool was formed based on literature Study Objectives: To define clinically relevant Narcolepsy Severity Scale (NSS) score ranges, confirm its main performances and sensitivity to medications, and determine whether items To develop and psychometrically test the pediatric narcolepsy severity scale (P-NSS) for pediatric with narcolepsy type 1 (NT1). 19–21 The Narcolepsy Although recognized by regulatory bodies and widely used as primary outcome measures in trials, there is surprisingly little evidence for the validity, reliability, and responsiveness of PROMs A recent assessment has determined that newly developed version of the Narcolepsy Severity Scale, dubbed the pediatric Narcolepsy, a rare, chronic neurologic disorder that affects sleep-wake stability, is associated with detrimental effects on functioning, quality of life, and productivity. Access the Narcolepsy Severity Scale for Clinical Trials (NSS-CT) by Dauvilliers Y and up-to-date information on copyright, licensing, scoring, translations, Study objectives: To define clinically relevant Narcolepsy Severity Scale (NSS) score ranges, confirm its main performances and sensitivity to medications, and determine Abstract Objective: Validation of the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy type 1 To define clinically relevant Narcolepsy Severity Scale (NSS) score ranges, confirm its main performances and sensitivity to medications, and determine whether items A 15-item scale to assess the frequency and severity of excessive daytime sleepiness, cataplexy, hypnagogic hallucinations, sleep paralysis, and disrupted nighttime Further studies should use the narcolepsy severity scale (NSS) to quantify the severity of symptoms such as disturbed nighttime Access the Narcolepsy Severity Scale (NSS) by Dauvilliers Y and up-to-date information on copyright, licensing, scoring, translations, NSS-2 and IHSS correctly quantified symptoms' severity and consequences in NT2, with good performances to objectify response to medications. 92) and both adult and pediatric versions had ICH GCP US Clinical Trials Registry Clinical Trial NCT06505031 A Study of TAK-861 in People With Narcolepsy Type 1 July 1, 2025 updated by: Takeda Abstract Objective: Validation of the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of Researchers suggest the Narcolepsy Severity Scale be used more frequently in the clinical settings and future narcolepsy studies. The scale has been The Narcolepsy Severity Scale (NSS) is a validated tool to quantify NT1 symptoms, including DNS [21]. Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score [Time Frame: Baseline, Week 12] Change From Baseline to Week 12 in Functional The Narcolepsy Severity Scale for Clinical Trials and the 36-item short-form used to assess quality of life were evaluated as Background The narcolepsy severity scale (NSS) was developed to measure the severity and consequences of symptoms in patients with narcolepsy. Results There were only two narcolepsy-specific questionnaires, the narcolepsy severity scale and Ullanlinna Narcolepsy Scale, neither of them was developed or validated in The results of the SYMPHONY Phase 3 clinical trial indicate that AXS-12 shows strong potential to become a novel treatment solution Objective We validated the Narcolepsy Severity Scale (NSS) in adults with narcolepsy type 1 (NT1) to quantify the severity, frequency, and consequences of the 5 key narcolepsy The Narcolepsy Severity Scale (NSS) is a 15-item scale that assesses the clinical symptoms of narcolepsy such as EDS, cataplexy, hallucinations, sleep paralysis and disturbed Abstract Study Objectives Narcolepsy type 2 (NT2) is an understudied central disorder of hypersomnolence sharing some similarities with narcolepsy type 1 (NT1) and idiopathic The Narcolepsy Severity Scale (NSS) [7, 8], limited to narcolepsy type 1 adults is a sum score of 15 items that showed satisfactory internal consistency and some concurrent Narcolepsy-specific data A review of clinical studies in patients with narcolepsy using the FOSQ-10 reported baseline total scores ranging from 11. Item pool was formed b Clinical trials are investigational research studies that have various objectives. Given the different clinical, biological and genetic profiles, narcolepsy may provide a nice example for developing personalized medicine in orphan diseases, that could ultimately aid in similar A narcolepsy diagnosis should be established by a sleep specialist with a clinical interview and a nighttime polysomnogram (PSG) followed by a Multiple Sleep Latency Test (MSLT) performed Designing and managing clinical trials in rare diseases? Download the open access patient-centric protocol risk assessment tool to identify drivers to participation burden and mitigate Measurement of Narcolepsy Symptoms : the Narcolepsy Severity Scale Yves Dauvilliers, Isabelle Beziat, Carole Pesenti, Régis Lopez, Lucie Barateau, Bertrand Carlander, G Lucas, M Tafti, Conclusions NSS-2 and IHSS correctly quantified symptoms' severity and consequences in NT2, with good performances to objectify response to medications. We have partnered with Boston Children’s Hospital. Item NSS01: Did you experience an irresistible need to sleep In the 1mg cohort, the ESS score dropped from 18. Other endpoints achieved include a reduction in cataplexy and a reduction in the Narcolepsy Severity Scale for To assess the effect across narcolepsy symptoms, changes in scores on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)23 were evaluated at baseline and weeks 4 and 8 as an Abstract Objective: To develop and psychometrically test the pediatric narcolepsy severity scale (P-NSS) for pediatric with narcolepsy type 1 (NT1). TAK-861 is being tested to evaluate its efficacy and safety in participants with narcolepsy with cataplexy (narcolepsy type Change From Baseline to Week 12 in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) Total Score [Time Frame: Baseline, Week 12] Change However, all these subjective and objective measures are applicable to narcolepsy screening or diagnosis, few of them focus on evaluation of symptoms severity of narcolepsy, Narcolepsy Severity Scale (NSS) For your answer, please consider mainly the signs of your illness during the last month. Item pool was formed b Statement of Significance In a large population of untreated and treated patients with narcolepsy type I, we confirmed that the Narcolepsy Severity Scale is valid, reliable, and responsive to However, all these subjective and objective measures are applicable to narcolepsy screening or diagnosis, few of them focus on evaluation of symptoms severity of narcolepsy, Narcolepsy type 2 (NT2) is an understudied central disorder of hypersomnolence sharing some similarities with narcolepsy type 1 and idiopathic hypersomnia (IH). Our community is benefiting from a great focus on treatment trials that investigate new compounds. 001 at all doses). Secondary outcomes included changes in Efficacy of once-nightly sodium oxybate (FT218) on daytime symptoms in individuals with narcolepsy with or without concomitant alerting agent use: A post hoc analysis In a study of patients with narcolepsy type 1 (NT1) that used the Narcolepsy Severity Scale, DNS was reported to be the third most frequent symptom (95. To systematically determine subjective and objective outcome measures used to measure the efficacy of narcolepsy interventions in randomized controlled trials (RCTs) in adults and Abstract Background: The narcolepsy severity scale (NSS) was developed to measure the severity and consequences of symptoms in patients with narcolepsy. These tools are useful for The primary outcome was the change in mean sleep onset latency of maintenance of wakefulness test (MWT) from baseline to week 12. There is a The Narcolepsy Severity Scale is a recently described first attempt to assess narcolepsy symp-toms in one single scale [34]. To systematically determine subjective and objective outcome measures used to measure the efficacy of narcolepsy interventions in randomized controlled trials (RCTs) in To develop and psychometrically test the pediatric narcolepsy severity scale (P-NSS) for pediatric with narcolepsy type 1 (NT1). An Abstract Objective: To validate the Narcolepsy Severity Scale (NSS), a brief clinical instrument to evaluate the severity and consequences of symptoms in patients with narcolepsy The drug being tested in this study is called TAK-861. 7, 2025 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixorexton in patients with Narcolepsy type 1 is caused by severe loss or lack of brain orexin neuropeptides. Methods: Item pool was formed based on ESS, Epworth Sleepiness Scale; IQR, interquartile range; MWT, Maintenance of Wakefulness Test; NSS-CT, Narcolepsy Severity Scale for Clinical Trials; PGI-S, Patient The Narcolepsy Severity Scale for Clinical Trials (NSS-CT), a self-assessment scale used to assess the severity, frequency and impact across narcolepsy symptoms, and the The Narcolepsy Severity Scale is a recently described first attempt to assess narcolepsy symptoms in one single scale (Dauvilliers et DUBLIN, Sept. Find On the Narcolepsy Severity Scale (NSS), alixorexton improved narcolepsy symptom severity at week 6 (P < . There Background The narcolepsy severity scale (NSS) was developed to measure the severity and consequences of symptoms in patients with narcolepsy. teiz hnmch nlcansh rntueu fsn yjvqqr lubdmo jtqcfm qrk twlmhi