Recruiting NCT07018713
A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xeomin, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada, Czechia, Denmark +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Chronic Migraine
Overview
In this clinical trial, participants with chronic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections. Trial details include: * Trial duration: 52 to 55 weeks; * Screening period: 4 to 5 weeks; * Treatment duration: 4 treatments, each about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.
Interventions
- Drug Xeomin
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl) - Drug Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Primary outcome measures
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Time frame: Baseline to month 6]
Secondary outcome measures (8)
- Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Time frame: Baseline to month 6]
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Time frame: Baseline to month 6]
- Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Time frame: Baseline to month 6]
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A [Time frame: Baseline to month 6]
- Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B [Time frame: Baseline to month 6]
- Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4) [Time frame: Baseline up to month 11]
- Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) [Time frame: Baseline to month 6]
- Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period [Time frame: Month 6]
Eligibility criteria
Inclusion criteria
- Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
- Participant age < 50 years at the time of migraine onset;
- Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≥ 15 headache days per month and history of ≥ 8 migraine days per month; and
- During the last 28 days of the screening period, participant experiencing: ≥ 15 headache days and ≥ 8 migraine days that qualify as such per the headache diary.
Exclusion criteria
- Diagnosis of other primary headache types, except tension-type headache, which is permitted;
- Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction;
- Diagnosis of secondary headache types, except medication overuse headache, which is permitted;
- Currently taking > 1 prescribed drug for the preventive treatment of migraine;
- Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 47 centers
- TrialSphere Corp, Merz Investigational Site #0010513 — Chandler
- Arizona Neuroscience Research, Merz Investigational Site #0010521 — Phoenix
- Baptist Health Medical Center, Merz Investigational Site #0010520 — Little Rock
- Chemidox Clinical Trials Inc, Merz Investigational Site #0010488 — Lancaster
- Clinical Research Institute, Merz Investigational Site #0010487 — Los Angeles
- BNL Health, Merz Investigational Site #0010501 — Los Angeles
- Clinical Trials Management Services, Merz Investigational Site #0010526 — Thousand Oaks
- Hasbani Neurology, Merz Investigational Site #0010509 — New Haven
- … and 39 more centers
Poland · 19 centers
- Centrum Medyczne Neuromed, Merz Investigational Site #0480117 — Bydgoszcz
- AthleticoMed, Merz Investigational Site #0480127 — Bydgoszcz
- ETG Debica, Merz Investigational Site #0480121 — Dębica
- Centrum Medyczne Pratia Gdynia, Merz Investigational Site #0480126 — Gdynia
- Silmedic Sp. z o.o., Merz Investigational Site #0480115 — Katowice
- Jan Banach Research Spot, Merz Investigational Site #0480059 — Krakow
- Pratia MCM, Merz Investigational Site #0480087 — Krakow
- FutureMeds, Merz Investigational Site #0480125 — Krakow
- … and 11 more centers
Spain · 13 centers
Center list to be confirmed — check the primary protocol.
Czechia · 5 centers
- Pratia Brno, Merz Investigational Site #4200053 — Brno
- Fakultní nemocnice Hradec Králové, Merz Investigational Site #4200056 — Hradec Králové
- CLINTRIAL, Merz Investigational Site #4200052 — Prague
- Axon Clinical, Merz Investigational Site #4200051 — Prague
- Neuropsychiatrie, Merz Investigational Site #4200054 — Prague
Germany · 5 centers
- Charité - Universitätsmedizin Berlin, Merz Investigational Site #0490398 — Berlin
- Kopfschmerzzentrum Frankfurt, Merz Investigational Site #0490394 — Frankfurt
- Universitätsmedizin Greifswald, Merz Investigational Site #0490397 — Greifswald
- Vitos Orthopädische Klinik Kassel, Merz Investigational Site #0490396 — Kassel
- Schmerzklinik Kiel GmbH, Merz Investigational Site #0490395 — Kiel
Italy · 5 centers
- Azienda Ospedaliera Universitaria Careggi, Merz Investigational Site #0390023 — Florence
- Ospedale San Raffaele, Merz Investigational Site #0390027 — Milan
- Istituto Auxologico Italiano, Merz Investigational Site #0390024 — Milan
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino, Merz Investigational Site #039 — Pavia
- IRCCS San Raffaele Roma, Merz Investigational Site #0390026 — Roma
Slovakia · 4 centers
Center list to be confirmed — check the primary protocol.
France · 3 centers
- CHU Clermont Ferrand, Merz Investigational Site #0330026 — Clermont-Ferrand
- Centre Hospitalier Universitaire Grenoble Alpes, Merz Investigational Site #0330069 — La Tronche
- CHU Nantes, Merz Investigational Site #0330068 — Nantes
Austria · 2 centers
- Medical University of Innsbruck, Merz Investigational Site #0430043 — Innsbruck
- Klinikum Klagenfurt Am Wörthersee, Merz Investigational Site #0430042 — Klagenfurt
Canada · 2 centers
- Genge Partners Inc., Merz Investigational Site #0010525 — Montreal
- CaRe Clinic, Merz Investigational Site #0010504 — Red Deer
Switzerland · 2 centers
Center list to be confirmed — check the primary protocol.
Denmark · 1 center
- Rigshospitalet-Glostrup, Merz Investigational Site #0450006 — Glostrup Municipality
United Kingdom · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07018713 · M602011084 · 2024-515682-34-00