JZP110-405-00 SHARP

• Research type

  Research Study

• Full title

  Solriamfetol’s Effect on Cognitive Health in Apnea Participants During a Randomized Placebo controlled Study (SHARP): a 5 Week Double blind, Placebo controlled, Randomized, Crossover, Multicenter Study of Solriamfetol in Improving Cognitive Function in Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea Plus Impaired Cognitive Function

• IRAS ID

  296361

• Contact name

  Caroline Streicher

• Contact email

  cstreicher@axsome.com

• Sponsor organisation

  Axsome Therapeutics, Inc

• Eudract number

  2020-004243-92

• Clinicaltrials.gov Identifier

  122590, IND Number; 211230, NDA

• Duration of Study in the UK

  0 years, 11 months, 4 days

• Research summary

  Research Summary

  This study will test a study drug (solriamfetol) for participants with obstructive sleep apnoea who feel very sleepy in the daytime and have reduced mental function. Obstructive sleep apnoea is a sleep problem that happens when muscle and soft tissue in the throat blocks the airways and makes it difficult to breathe while asleep. People with obstructive sleep apnoea may have a lower quality of sleep at night, which can mean they are very sleepy in the daytime. Daytime sleepiness can reduce mental function, including the ability to learn, think, concentrate, remember things, solve problems, or make decisions. This study is organized and funded by Jazz Pharmaceuticals, Inc. (the Sponsor).
  Up to 164 people will take part in this study in about 6 countries. Participants could be in the study up to 75 days (just under 11 weeks) and taking part will involve 4 or 5 visits to the study centre, and, 4 or 5 phone calls.

  Summary of Results

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Fsearch%253Fquery%253D2020-004243-92%2FNBTI%2FSLi6AQ%2FAQ%2Fe150b7d2-176d-4d78-b476-f92431b55a6e%2F1%2FIwFmdFlDWo&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7C088f27ff4fd742b11cf008dd357eab23%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638725540324907898%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Z5e%2BJaJfCAjJNNN7DnwthG65ksqVwkvUwiO7b16OTAw%3D&reserved=0
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.clinicaltrialsregister.eu%252Fctr-search%252Ftrial%252F2020-004243-92%252Fresults%2FNBTI%2FSLi6AQ%2FAQ%2Fe150b7d2-176d-4d78-b476-f92431b55a6e%2F2%2FPPvreMzorO&data=05%7C02%7Charrow.rec%40hra.nhs.uk%7C088f27ff4fd742b11cf008dd357eab23%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638725540324931256%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=B5XOhirGaDjhq5UKwNTGmnRnq4vJy91gzRmxEJ6OJcg%3D&reserved=0

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  21/LO/0383

• Date of REC Opinion

  31 Aug 2021

• REC opinion

  Further Information Favourable Opinion