Eptinezumab in patients with episodic Cluster Headache (‘ALLEVIATE’)

• Research type

  Research Study

• Full title

  Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache

• IRAS ID

  1003503

• Contact name

  Peter Goadsby

• Contact email

  peter.goadsby@kcl.ac.uk

• Eudract number

  2020-001969-37

• Clinicaltrials.gov Identifier

  NCT04688775

• Research summary

  The purpose of this study is to evaluate the efficacy of eptinezumab in patients with episodic Cluster Headache (eCH).
  Eligible patients will be randomly assigned to receive, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner
  during the Placebo-controlled Period and Active Treatment Period of the study.
  The total duration of the study is 24 weeks, including a safety follow up period of 8 weeks.

  Lay Summary of Results

  Lundbeck are using a third party to draft the Plain Language Summary which will take 1-2 weeks, and then a patient review panel may be used to review the wording, over a 2-4 week review period. The lay summary will be published on https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.trialsummaries.com%2FNBTI%2Fmxm4AQ%2FAQ%2F3b8b40f6-14a3-4ce9-992d-e5ea15021288%2F1%2FXSMUy3bJ7w&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cafa161da504e4ffa557108dcd7cd8987%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638622524982871288%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=PzXKzcWuaXcXTF4oiAYS1LE%2Bbs%2B3wX%2B6ukcp1Pfj374%3D&reserved=0 once finalised, which is expected to be in November 2024.
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04688775%253Ftab%253Dresults%2FNBTI%2Fmxm4AQ%2FAQ%2F3b8b40f6-14a3-4ce9-992d-e5ea15021288%2F2%2FfdJTuuak37&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cafa161da504e4ffa557108dcd7cd8987%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638622524982905715%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=TQYFk4baGYXRwiTVgbZ1CpOPiKEquqFIXS4rtnQq2pg%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: High level results presented at AHS conference (June 2024).
  Publication in a peer review journal pending, but we cannot commit to a date.
  Publication on a website is completed for clinicaltrials.gov (09Aug2024) and pending for EudraCT (05Oct2024).

  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Pending
  If yes, describe and/or provide URLs to materials shared and how they were shared:
  If pending, date when feedback is expected: 01/12/2024
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Listing the study on the sponsor’s platform for clinical data sharing (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.lundbeck.com%2Fglobal%2Four-science%2Fclinical-data-sharing&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Cafa161da504e4ffa557108dcd7cd8987%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638622524982920110%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QwT6FYK3RGkAYOcTwffNgj2oKaorTFkkUVYRvUEXATo%3D&reserved=0) will await that the primary manuscript has been accepted for peer-reviewed publication.
  Have you enabled sharing of tissue samples and associated data with others?: Yes
  If yes, describe or provide a URL: Samples are stored in Lundbeck's internal biobank. External parties can get access to samples in the biobank for e.g., academic or industrial research endeavors, provided they do not conflict with Lundbeck's commercial interests. There is currently no outfacing webpage for this resource. However, Lundbeck is engaging actively with the scientific communities and tries to ensure good use of the biobank samples also externally, such as in consortia.
  If no, explain why:
  Submitted on: 18/09/2024

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0056

• Date of REC Opinion

  4 Mar 2021

• REC opinion

  Further Information Favourable Opinion