Migraine Headache Clinical Trial
Official title:
A Phase 4, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Chronic Migraine and Medication Overuse Headache
Verified date | February 2024 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study 20170703 is a phase 4, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of erenumab against placebo in participants with chronic migraine (CM) who have a history of at least 1 preventive treatment failure and are diagnosed with medication overuse headache (MOH).
Status | Completed |
Enrollment | 620 |
Est. completion date | June 13, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Eligibility criteria will be evaluated during the up to 3-week screening period (part 1) and a 4-week baseline period (part 2). At the end of baseline period, participants who successfully met eligibility criteria will be randomized on study. Key Inclusion Criteria Part 1: To be assessed during the 3-week screening period, prior to the baseline period. Participants are eligible to be included in the study only if all of the following criteria apply: - Participant has provided informed consent prior to initiation of any study-specific activities/procedures - Age = 18 years on entry into the study - Documented history of migraine without aura and/or migraine with aura according to the ICHD-3 classification for = 12 months at screening - Documented history of CM for a minimal duration of 6 months before screening - Current diagnosis of MOH - History of treatment failure with at least 1 preventive treatment as defined as treatment discontinuation due to lack of efficacy, adverse event or general poor tolerability Key Exclusion Criteria Part 1 Participants are excluded from the study if any of the following criteria apply: Disease Related - Age > 50 years at migraine onset or > 65 years at CM onset - History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia - Current concomitant diagnosis of a secondary type of headache other than MOH - No therapeutic response in prevention of migraine after an adequate therapeutic trial of > 3 preventive treatment categories - Changes in drug regimen (ie, changes in dose or frequency of use) of an allowed migraine preventive medication within 2 months prior to start of baseline - Received botulinum toxin in the head and/or neck region within 4 months prior to screening - Documented history of treatment with an anti-calcitonin gene-related peptide product preventive treatment - Anticipated to require any excluded medication/device or procedure during the study Other Medical Conditions - History or evidence of unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen's physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion - Evidence of "recreational use" of illicit drugs within 12 months prior to screening, based on medical records, self-report, or a positive drug test performed during screening. Key Inclusion Criteria Part 2. To be assessed at the end of the baseline period and prior to enrollment into DBTP. Based on information collected through the electronic diary (eDiary) during the baseline period, the following requirements must be met: -= 14 headache days during the 28-day baseline period out of which = 8 headache days meet criteria as migraine days - Observation of acute migraine medication overuse during the baseline period. Medication overuse at baseline is defined as: - = 10 days of combination treatment OR - = 10 days of short-acting opioids/opioid-containing medication OR - = 10 days of triptans, ergots, OR - = 15 days of nonsteroidal anti-inflammatory drugs or simple analgesics intake - At least 2 acute headache medication days per week for each week with at least 5 diary days - Demonstrated at least 80% compliance with the eDiary (eg, must complete eDiary items on at least 23 out of 28 days during the baseline period) Key Exclusion Criteria Part 2 Study Procedures - Changed or planning to change the dose of an allowed concomitant medication that may have migraine preventive effect during baseline period or post-randomization - Unstable or clinically significant medical condition that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion Contraception, pregnancy or breastfeeding - Unwillingness to maintain acceptable contraception method, when applicable - Evidence of pregnancy or breastfeeding per participant self-report, medical records or positivity on baseline pregnancy screening tests, through end of study |
Country | Name | City | State |
---|---|---|---|
Australia | The Alfred Hospital | Melbourne | Victoria |
Australia | Holdsworth House Medical Practice | Sydney | New South Wales |
Austria | Medizinische Universitaet Innsbruck | Innsbruck | |
Austria | Klinikum Klagenfurt am Woerthersee | Klagenfurt | |
Austria | Konventhospital der Barmherzigen Brueder Linz | Linz | |
Austria | Universitaetsklinikum Allgemeines Krankenhaus Wien | Wien | |
Czechia | Fakultni nemocnice u svate Anny v Brne | Brno | |
Czechia | Neurologie Brno sro | Brno | |
Czechia | INEP | Praha | |
Czechia | Dado Medical sro | Praha 2 | |
Czechia | Thomayerova nemocnice | Praha 4 | |
Czechia | Mudr Stanislav Bartek sro | Prerov | |
Czechia | Vestra Clinics sro | Rychnov nad Kneznou | |
Finland | Helsingin Paansarkykeskus Aava | Helsinki | |
Finland | Northern Cinical Trial Coordinators | Oulu | |
Finland | Suomen Terveystalo | Tampere | |
Finland | Terveystalo Pulssi | Turku | |
France | Hospices Civils de Lyon - Hopital neurologique Pierre Wertheimer | Bron cedex | |
France | Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro | Lille | |
France | Hopital La Timone | Marseille cedex 05 | |
France | Centre Hospitalier Universitaire de Nice - Hopital de Cimiez | Nice cedex 1 | |
France | Groupe hospitalier Paris Saint Joseph | Paris | |
France | Hopital Lariboisiere | Paris | |
France | Centre Hospitalier Universitaire de Poitiers | Poitiers Cedex | |
France | Centre Hospitalier Annecy Genevois | Pringy Cedex | |
France | Centre Hospitalier Universitaire Saint-Etienne - Hopital Nord | Saint-Etienne cedex 2 | |
Hungary | Jahn Ferenc Del-pesti Korhaz es Rendelointezet | Budapest | |
Hungary | Obudai Egeszsegugyi Centrum Kft | Budapest | |
Hungary | Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet | Budapest | |
Hungary | Swiss Premium Egeszsegkozpont | Budapest | |
Hungary | Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz | Debrecen | |
Hungary | Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz | Miskolc | |
Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar | Szeged | |
Italy | IRCCS Istituto delle Scienze Neurologiche di Bologna Ospedale Bellaria | Bologna | |
Italy | Azienda Ospedaliero Universitaria Mater Domini | Catanzaro | |
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | Fondazione IRCCS Istituto Neurologico Carlo Besta | Milano | |
Italy | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | |
Italy | Fondazione Istituto Neurologico Nazionale C Mondino IRCCS | Pavia | |
Italy | IRCCS San Raffaele Pisana | Roma | |
Poland | Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Spolka Jawna | Ksawerow | |
Poland | Jerzy Petz Mediq Niepubliczny Zaklad Opieki Zdrowotnej | Legionowo | |
Poland | Gabinet Lekarski Jacek Rozniecki | Lodz | |
Poland | Clinical Research Center Spzoo Medic-R Spolka Komandytowa | Poznan | |
Poland | RCMed Oddzial Sochaczew | Sochaczew | |
Portugal | Hospital Professor Doutor Fernando Fonseca, EPE | Amadora | |
Portugal | Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria | Lisboa | |
Portugal | Hospital da Luz, SA | Lisboa | |
Portugal | Campus Neurologico Senior | Torres Vedras | |
Spain | Hospital Universitari Vall d Hebron | Barcelona | Cataluña |
Spain | Hospital Universitari de Bellvitge | Hospitalet de Llobregat | Cataluña |
Spain | Hospital Universitario Virgen del Rocio | Sevilla | Andalucía |
Spain | Hospital Clinico Universitario de Valencia | Valencia | Comunidad Valenciana |
Spain | Hospital Universitari i Politecnic La Fe | Valencia | Comunidad Valenciana |
Spain | Hospital Clinico Universitario de Valladolid | Valladolid | Castilla León |
Spain | Hospital Clinico Universitario Lozano Blesa | Zaragoza | Aragón |
United Kingdom | Queen Elizabeth University Hospital | Glasgow | |
United Kingdom | Hull Royal Infirmary | Hull | |
United Kingdom | The Walton Centre NHS Foundation Trust | Liverpool | |
United Kingdom | Kings College London | London | |
United Kingdom | Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | |
United Kingdom | John Radcliffe Hospital | Oxford | |
United States | Dent Neurosciences Research Center | Amherst | New York |
United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
United States | Citizens Memorial Healthcare | Bolivar | Missouri |
United States | Core Healthcare Group | Cerritos | California |
United States | Onsite Clinical Solutions LLC | Charlotte | North Carolina |
United States | Clinical Trial Investigator Clinical Research Center | Cincinnati | Ohio |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Axiom Research | Colton | California |
United States | Texas Neurology, PA | Dallas | Texas |
United States | Fort Wayne Neurological Center | Fort Wayne | Indiana |
United States | Neurology Center of New England PC | Foxboro | Massachusetts |
United States | Aurora BayCare Medical Center | Green Bay | Wisconsin |
United States | Marshall University | Huntington | West Virginia |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | University of Kentucky | Lexington | Kentucky |
United States | Clinical Research Institute | Los Angeles | California |
United States | Saint Lukes Clinic | Meridian | Idaho |
United States | University of Miami Miller School of Medicine | Miami | Florida |
United States | Floridian Clinical Research LLC | Miami Lakes | Florida |
United States | Clinical Research Institute Inc | Minneapolis | Minnesota |
United States | Nashville Neuroscience Group | Nashville | Tennessee |
United States | DelRicht Research | New Orleans | Louisiana |
United States | Clinical Neuroscience Solutions | Orlando | Florida |
United States | College Park Family Care Center | Overland Park | Kansas |
United States | Emerald Coast Center for Neurological Disorders | Pensacola | Florida |
United States | Allegheny Health Network Cancer Institute at Mellon Pavilion | Pittsburgh | Pennsylvania |
United States | Preferred Primary Care Physicians, Inc | Pittsburgh | Pennsylvania |
United States | Collective Medical Research | Prairie Village | Kansas |
United States | Mercy Research | Saint Louis | Missouri |
United States | Wasatch Clinical Research LLC | Salt Lake City | Utah |
United States | University of South Florida | Tampa | Florida |
United States | The George Washington Medical Faculty Associates | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Australia, Austria, Czechia, Finland, France, Hungary, Italy, Poland, Portugal, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Absence of Medication Overuse Headaches (MOH) at Month 6 | Absence of MOH at month 6 was defined as mean monthly acute headache medication days (AHMD) < 10 days over months 4, 5, and 6 (weeks 13 through 24) or mean monthly headache days < 14 days over months 4, 5, and 6 (weeks 13 through 24) of the DBTP where an AHMD was defined as a calendar day in which the participant took at least 1 acute headache medication. | Months 4, 5, and 6 (weeks 13 through 24) of the DBTP | |
Secondary | Change From Baseline in Mean Monthly AHMDs Over Months 4, 5, and 6 | An AHMD was defined as a calendar day in which the participant takes at least 1 acute headache medication. Acute headache medications included triptan-based, ergotamine-based and ditan-based migraine medications, non-opioid and opioid-containing acute headache medications, non-opioid butalbital and opioid-containing butalbital containing medications. | Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP | |
Secondary | Number of Participants With Sustained MOH Remission at Month 6 | Sustained MOH remission was defined as the absence of MOH at month 3 (week 12) and month 6 (week 24) of the DBTP. Absence of MOH was achieved when mean monthly AHMD < 10 days or mean monthly headache days < 14 days over the 3-month period (weeks 12 to 24). | Month 3 (week 12) to month 6 (week 24) of the DBTP | |
Secondary | Change From Baseline in Mean Monthly Average Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) | The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The physical impairment domain includes 5 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. | Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP | |
Secondary | Change From Baseline in Mean Monthly Average Impact on Everyday Activities Domain Scores as Measured by the MPFID | The MPFID is a self-administered 13-item instrument measuring physical functioning, completed daily using the eDiary. The impact on everyday activities domain includes 7 items. Participants respond to items using a 5-point scale, with difficulty items ranging from "Without any difficulty" to "Unable to do", and frequency items ranging from "None of the time" to "All of the time". Each item is assigned a score from 1 to 5, with 5 representing the greatest burden. For each domain, the scores are calculated as the sum of the item responses and the sum is rescaled to a 0 to 100 scale, with higher scores representing greater impact of migraine, i.e., higher burden. | Baseline and months 4, 5, and 6 (weeks 13 through 24) of the DBTP | |
Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as any adverse event (AE) that started on or after first dose of IP, and up to the end of the study (52 weeks).
Any clinically significant changes in vital signs were included as TEAEs. |
Day 1 to Week 24 (DBTP) and Week 25 to 52 weeks (OLTP) |
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