Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine

NCT02974153 | Completed Phase 3 Results DMC

• 1 other identifier: ALD403-CLIN-011
• Study Type: interventional
• Target: 1,121
• Locations: 13 countries
• Sites: 144

Brief Summary

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Monthly Migraine Days

  Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12

  Week 1-12

Secondary Outcomes (26)

• 75% Migraine Responder Rate

  Week 1-12

• 75% Migraine Responder Rate - 4 Week

  Week 1-4

• 50% Migraine Responder Rate

  Week 1-12

• Percentage of Participants With a Migraine on the Day After Dosing

  Day 1

• Change in Monthly Acute Medication Days

  Week 1-12

Study Arms (3)

ALD403 (Eptinezumab) Dose Level 1

EXPERIMENTAL

ALD403 (Eptinezumab) Dose Level 1 (IV)

Biological: ALD403 (Eptinezumab)

ALD403 (Eptinezumab) Dose Level 2

EXPERIMENTAL

ALD403 (Eptinezumab) Dose Level 2 (IV)

Biological: ALD403 (Eptinezumab)

Placebo

PLACEBO COMPARATOR

Placebo (IV)

Biological: Placebo

Interventions

ALD403 (Eptinezumab) BIOLOGICAL

Also known as: Eptinezumab-jjmr, Vyepti

ALD403 (Eptinezumab) Dose Level 1; ALD403 (Eptinezumab) Dose Level 2

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
• During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
• Headache eDiary was completed on at least 24 of the 28 days prior to randomization.

You may not qualify if:

• Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
• Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
• Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
• History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
• Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
• Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.

Sponsors & Collaborators

• Alder Biopharmaceuticals, Inc.: lead

Study Sites (144)

Research Site

Birmingham, Alabama, 35235, United States

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Phoenix, Arizona, 85032, United States

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Little Rock, Arkansas, 72211, United States

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Carlsbad, California, 92011, United States

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Oceanside, California, 92056, United States

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Orange, California, 92868, United States

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Oxnard, California, 93030, United States

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Palo Alto, California, 94304, United States

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Redlands, California, 92374, United States

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San Diego, California, 92108, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90502, United States

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Colorado Springs, Colorado, 80918, United States

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New London, Connecticut, 06320, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33155, United States

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Orlando, Florida, 32806, United States

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Tampa, Florida, 33606, United States

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West Palm Beach, Florida, 33407, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30328, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, 30030, United States

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Champaign, Illinois, 61820, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60642, United States

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Anderson, Indiana, 46011, United States

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Des Moines, Iowa, 50309, United States

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Overland Park, Kansas, 66212, United States

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Prairie Village, Kansas, 66208, United States

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Wichita, Kansas, 67207, United States

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Marrero, Louisiana, 70072, United States

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Waldorf, Maryland, 20603, United States

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Boston, Massachusetts, 02135, United States

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North Attleboro, Massachusetts, 02740, United States

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Watertown, Massachusetts, 02472, United States

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Ann Arbor, Michigan, 48104, United States

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Minneapolis, Minnesota, 55402, United States

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Flowood, Mississippi, 39232, United States

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City of Saint Peters, Missouri, 63303, United States

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Springfield, Missouri, 65810, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89113, United States

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Lebanon, New Hampshire, 03756, United States

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Princeton, New Jersey, 08540, United States

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Albuquerque, New Mexico, 87102, United States

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Amherst, New York, 14226, United States

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Brooklyn, New York, 11229, United States

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New York, New York, 10016, United States

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New York, New York, 10019, United States

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Plainview, New York, 11803, United States

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Rochester, New York, 14609, United States

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Durham, North Carolina, 27705, United States

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High Point, North Carolina, 27262, United States

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Canton, Ohio, 44718, United States

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Dayton, Ohio, 45432, United States

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Oklahoma City, Oklahoma, 73116, United States

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Scottdale, Pennsylvania, 15683, United States

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Smithfield, Pennsylvania, 15478, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Chattanooga, Tennessee, 37404, United States

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Chattanooga, Tennessee, 37421, United States

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Memphis, Tennessee, 38119, United States

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Nashville, Tennessee, 37203, United States

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Dallas, Texas, 75214, United States

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Houston, Texas, 77058, United States

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Houston, Texas, 77081, United States

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North Richland Hills, Texas, 76180, United States

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San Antonio, Texas, 78258, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84123, United States

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Richmond, Virginia, 23294, United States

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Bellevue, Washington, 98007, United States

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Spokane, Washington, 99202, United States

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Brussels, 1090, Belgium

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Liège, 4000, Belgium

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Brno, 61500, Czechia

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Choceň, 565 01, Czechia

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Prague, 100 34, Czechia

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Prague, 18200, Czechia

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Glostrup Municipality, 2600, Denmark

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Viborg, 8800, Denmark

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Tbilisi, 0112, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0179, Georgia

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Tbilisi, 0186, Georgia

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Berlin, 10117, Germany

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Erlangen, 91054, Germany

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Hamburg, 20246, Germany

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Nordheim, 45122, Germany

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Unterhaching, 82008, Germany

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Budapest, 1033, Hungary

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Budapest, 1083, Hungary

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Budapest, 1145, Hungary

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Pécs, 7623, Hungary

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Ancona, 60020, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Napoli, 80131, Italy

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Pavia, 27100, Italy

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Roma, 00163, Italy

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Kazan', 420064, Russia

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Krasnoyarsk, 660037, Russia

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Moscow, 121467, Russia

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Novosibirsk, 630051, Russia

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Novosibirsk, 630054, Russia

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Saint Petersburg, 191144, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 194223, Russia

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Yaroslavl, 150030, Russia

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Yekaterinburg, 620102, Russia

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Banská Bystrica, 97404, Slovakia

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Dolný Kubín, 026 01, Slovakia

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Dubnica nad Váhom, 01841, Slovakia

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Krompachy, 053 42, Slovakia

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Alicante, 03010, Spain

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Barcelona, 08035, Spain

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Guadalajara, 19002, Spain

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Lleida, 25198, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Madrid, 28222, Spain

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Madrid, 28223, Spain

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Navarrés, 31008, Spain

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Santander, 39008, Spain

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Seville, 41013, Spain

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Terrassa, 08221, Spain

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Valencia, 46026, Spain

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Valladolid, 47005, Spain

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Dnipro, 49045, Ukraine

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Dnipropetrovsk, 49027, Ukraine

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Ivano-Frankivsk, 76008, Ukraine

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Kharkiv, 61068, Ukraine

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Kharkiv, 61103, Ukraine

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Lviv, 79010, Ukraine

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Odesa, 65014, Ukraine

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Vinnytsia, 21005, Ukraine

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Zaporizhzhya, 69065, Ukraine

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Glasgow, G51 4TF, United Kingdom

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Inverness, IV2 3UJ, United Kingdom

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London, SE5 9PL, United Kingdom

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Newcastle, NE1 4LP, United Kingdom

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Salford, M8 8HD, United Kingdom

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Stoke-on-Trent, ST4 7LN, United Kingdom

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Related Publications (14)

• Tepper SJ, Diamond ML, Hirman J, Asher D, Fiore D, Cady R. Eptinezumab treatment was associated with longer interictal headache/migraine periods which corresponded to greater improvements in patient-reported quality of life measures. J Neurol. 2024 Dec 12;272(1):4. doi: 10.1007/s00415-024-12809-z.

  PMID: 39666143 DERIVED

• Kaniecki RG, Friedman DI, Asher D, Hirman J, Cady R. Improving to Four or Fewer Monthly Headache Days Per Month Provides a Clinically Meaningful Therapeutic Target for Patients with Chronic Migraine. Pain Ther. 2023 Oct;12(5):1179-1194. doi: 10.1007/s40122-023-00525-x. Epub 2023 Jun 28.

  PMID: 37378754 DERIVED

• Pozo-Rosich P, Dodick DW, Ettrup A, Hirman J, Cady R. Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies. BMC Neurol. 2022 Oct 25;22(1):394. doi: 10.1186/s12883-022-02914-9.

  PMID: 36284281 DERIVED

• Cowan RP, Marmura MJ, Diener HC, Starling AJ, Schim J, Hirman J, Brevig T, Cady R. Quantity changes in acute headache medication use among patients with chronic migraine treated with eptinezumab: subanalysis of the PROMISE-2 study. J Headache Pain. 2022 Sep 6;23(1):115. doi: 10.1186/s10194-022-01482-0.

  PMID: 36068494 DERIVED

• Apelian R, Boyle L, Hirman J, Asher D. Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2. J Headache Pain. 2022 Apr 18;23(1):48. doi: 10.1186/s10194-022-01418-8.

  PMID: 35436857 DERIVED

• McAllister P, Kudrow D, Cady R, Hirman J, Ettrup A. Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine. Cephalalgia. 2022 Sep;42(10):1005-1012. doi: 10.1177/03331024221089567. Epub 2022 Mar 25.

  PMID: 35332807 DERIVED

• Ashina M, McAllister P, Cady R, Hirman J, Ettrup A. Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2. Cephalalgia. 2022 Jul;42(8):696-704. doi: 10.1177/03331024221077646. Epub 2022 Mar 18.

  PMID: 35302389 DERIVED

• Buse DC, Winner PK, Charleston L 4th, Hirman J, Cady R, Brevig T. Early response to eptinezumab indicates high likelihood of continued response in patients with chronic migraine. J Headache Pain. 2022 Feb 21;23(1):29. doi: 10.1186/s10194-022-01387-y.

  PMID: 35189811 DERIVED

• Martin V, Nagy AJ, Janelidze M, Giorgadze G, Hirman J, Cady R, Mehta L, Buse DC. Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2. Clin Ther. 2022 Mar;44(3):389-402. doi: 10.1016/j.clinthera.2022.01.006. Epub 2022 Feb 5.

  PMID: 35131090 DERIVED

• Lipton RB, Charleston L 4th, Tassorelli C, Brevig T, Hirman J, Cady R. Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a >/= 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials. J Headache Pain. 2022 Feb 7;23(1):23. doi: 10.1186/s10194-022-01386-z.

  PMID: 35130836 DERIVED

• Smith TR, Spierings ELH, Cady R, Hirman J, Ettrup A, Shen V. Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies. J Headache Pain. 2021 Nov 25;22(1):143. doi: 10.1186/s10194-021-01360-1.

  PMID: 34823467 DERIVED

• Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5.

  PMID: 33781209 DERIVED

• Silberstein S, Diamond M, Hindiyeh NA, Biondi DM, Cady R, Hirman J, Allan B, Pederson S, Schaeffler B, Smith J. Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study. J Headache Pain. 2020 Oct 6;21(1):120. doi: 10.1186/s10194-020-01186-3.

  PMID: 33023473 DERIVED

• Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, Pederson S, Allan B, Cady R. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020 Mar 31;94(13):e1365-e1377. doi: 10.1212/WNL.0000000000009169. Epub 2020 Mar 24.

  PMID: 32209650 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 28, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

HU (4); CZ (4); US (74); DK (2); GE (4); DE (5); UA (9); GB (6); IT (6); BE (2); ES (14); RU (10); SL (4)