Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.
Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.
Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Start Date24 Sep 2024

Sponsor / Collaborator

AbbVie, Inc.

NCT06414044

/ RecruitingNot Applicable

STudio Osservazionale Sull'Efficacia, Sicurezza e tollerabilità di Atogepant in Pazienti Real Life Affetti da Emicrania in Italia (Studio STAR)

The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of atogepant as preventive migraine treatment in a cohort of episodic or chronic migraine patients.

Start Date09 May 2024

Sponsor / Collaborator

University of Florence

[+8]

CTR20240519

/ RecruitingPhase 3

一项评价 Atogepant 用于偏头痛急性发作治疗的疗效、安全性、耐受性和效果一致性的随机、双盲、安慰剂对照、多次发作研究（ECLIPSE）

[Translation] A randomized, double-blind, placebo-controlled, multiple-attack study to evaluate the efficacy, safety, tolerability, and consistency of effect of atogepant in the acute treatment of migraine (ECLIPSE)

评价Atogepant单次给药相比安慰剂治疗单次偏头痛急性发作的疗效。评价Atogepant治疗偏头痛急性单次发作和多次发作的安全性和耐受性，并评价治疗多次发作的效果一致性。

[Translation]

To evaluate the efficacy of a single dose of Atogepant compared with placebo in the treatment of a single acute migraine attack. To evaluate the safety and tolerability of Atogepant in the treatment of acute single and multiple migraine attacks, and to evaluate the consistency of the effect in the treatment of multiple attacks.

Start Date16 Apr 2024

Sponsor / Collaborator

Forest Laboratories Ireland Ltd.

[+2]

100 Clinical Results associated with Atogepant

100 Translational Medicine associated with Atogepant

100 Patents (Medical) associated with Atogepant

118

Literatures (Medical) associated with Atogepant

28 Jan 2025·Neurology

Early Improvements With Atogepant for the Preventive Treatment of Migraine

Article

Author: Smith, Jonathan H. ; Liu, Yingyi ; Lipton, Richard B. ; Reuter, Uwe ; Tassorelli, Cristina ; Holle-Lee, Dagny ; Neel, Brian ; Gottschalk, Christopher H. ; Stokes, Jonathan ; Harriott, Andrea M. ; Guo, Hua ; Dabruzzo, Brett ; Gandhi, Pranav ; Nagy, Krisztian

BACKGROUND AND OBJECTIVESThree phase 3 trials demonstrated the efficacy and safety of atogepant in episodic migraine (EM) and chronic migraine (CM) across 12-week treatment periods. This analysis evaluates improvements in efficacy and functional outcomes in the first 4 weeks of treatment with the oral calcitonin gene-related peptide receptor antagonist, atogepant, for the preventive treatment of migraine.METHODSADVANCE, ELEVATE, and PROGRESS were phase 3, multicenter, randomized, double-blind, placebo-controlled 12-week trials. ADVANCE and ELEVATE included participants aged 18-80 years with >1 year history of EM and 4-14 monthly migraine days (MMDs). ELEVATE required previous treatment failures to 2-4 classes of oral preventives. PROGRESS included participants aged 18-80 years with >1 year history of CM, ≥15 monthly headache days, and ≥8 MMDs. This analysis reports the atogepant 60 mg once daily (QD) and placebo treatment arms. Outcomes included efficacy endpoints (reporting a migraine day on day 1, change from baseline in weekly migraine days [WMDs] at weeks 1-4, and in MMDs in the first 4 weeks) and functional endpoints evaluated by the Activity Impairment in Migraine-Diary (AIM-D) at weeks 1-4 and the European Quality-of-Life 5-Dimension 5-Level (EQ-5D-5L) at weeks 1-2 and 4.RESULTSThe modified intent-to-treat population included the ADVANCE (atogepant, n = 222; placebo, n = 214), ELEVATE (atogepant, n = 151; placebo, n = 154), and PROGRESS (atogepant, n = 256; placebo, n = 246) studies. Atogepant-treated participants had greater reductions in the proportion of participants with a migraine day on day 1. The odds ratio compared with placebo was 0.39 (95% CI 0.23-0.67; p = 0.0006) in ADVANCE, 0.53 (95% CI 0.29-0.94, p = 0.031) in ELEVATE, and 0.63 (95% CI 0.43-0.93, p = 0.021) in PROGRESS. Atogepant treatment reduced WMDs at weeks 1-4 and MMDs in the first 4 weeks, and improved AIM-D and EQ-5D-5L at all assessed timepoints for weeks 1-4 compared with placebo.DISCUSSIONSAtogepant 60 mg QD demonstrated superiority to placebo in efficacy and functional measures in the first 4 weeks of treatment across 3 preventive studies, 2 in EM and 1 in CM.TRIAL REGISTRATIONClinicalTrials.gov NCT03777059; NCT04740827; NCT03855137. Submitted: 12/13/2018; 02/02/2021; 02/25/2019. First patient enrolled: 12/14/2018; 03/05/2021; 03/11/2019 clinicaltrials.gov/ct2/show/NCT03777059. clinicaltrials.gov/ct2/show/NCT04740827 clinicaltrials.gov/ct2/show/NCT03855137.CLASSIFICATION OF EVIDENCEThis study provides Class II evidence that atogepant 60 mg QD reduces migraine frequency and improves functional outcomes within 4 weeks of initiation in patients with EM and patients with CM.

01 Dec 2024·Cephalalgia

Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials

Article

Author: Liu, Yingyi ; Tassorelli, Cristina ; Lipton, Richard B. ; Trugman, Joel M. ; Nagy, Krisztian ; Stokes, Jonathan ; Pozo-Rosich, Patricia ; Gandhi, Pranav ; Christie, Suzanne ; Gottschalk, Christopher ; Luo, Lei

Background We aimed to assess the effects of preventive migraine treatment with atogepant vs. placebo on patient-reported quality of life and functioning. Methods Analyses of patient-reported outcomes from three 12-week, randomized, placebo-controlled trials evaluating preventive migraine treatment with atogepant 60 mg once-daily: ADVANCE (low-frequency episodic migraine [LFEM], 4–8 monthly migraine days [MMDs] and high-frequency episodic migraine [HFEM], 8–14 MMDs), PROGRESS (chronic migraine, CM) and ELEVATE (episodic migraine in those previously failed by two to four classes of oral preventive treatments). Results Least squares mean differences (95% confidence interval (CI)) in change from baseline were greater ( p < 0.05) for atogepant vs. placebo for Migraine-Specific Quality of Life questionnaire Role Function–Restrictive domain scores at week 12 (ADVANCE: LFEM 12.0 (95% CI = 6.0–18.0), HFEM 9.9 (95% CI = 3.4–16.4); PROGRESS: 6.2 (95% CI = 2.5–9.8); ELEVATE: 17.7 (95% CI = 13.1–22.3)), for Headache Impact Test-6 total scores at week 12 (ADVANCE: LFEM −4.7 (95% CI = −6.7 to −2.7); HFEM −3.4 (95% CI = −5.5 to −1.2); PROGRESS: −2.8 (95% CI = −4.1 to −1.4); ELEVATE: −6.5 (95% CI = −8.3 to −4.7)) and for Activity Impairment in Migraine–Diary-Performance of Daily Activities scores across 12 weeks (ADVANCE: LFEM −2.3 (95% CI = −3.9 to −0.7), HFEM −4.5 (95% CI = −6.9 to −2.2); PROGRESS: −3.4 (95% CI = −5.3 to −1.5); ELEVATE: −4.7 (95% CI = −6.4 to −3.1)). Conclusions Preventive migraine treatment with atogepant 60 mg once-daily vs. placebo improved measures of migraine-related quality of life and functioning among participants with different headache frequencies and histories of previous treatment failure. Trial Registration: ClinicalTrials.gov: NCT03777059 (ADVANCE); NCT03855137 (PROGRESS); NCT04740827 (ELEVATE)

01 Dec 2024·Revue Neurologique

Migraine treatment: Position paper of the French Headache Society

Review

Author: Gollion, C ; Valade, D ; Lantéri-Minet, M ; Giraud, P ; Mawet, J ; Corand, V ; Moreau, N ; Grangeon, L ; Lucas, C ; Guégan-Massardier, E ; Demarquay, G ; de Gaalon, S ; Ducros, A ; Roos, C ; Moisset, X ; Donnet, A

The French migraine management recommendations were published in 2021. However, in the last three years, new data have come to light and new drugs have been approved (eptinezumab, rimegepant and atogepant) by the European Medicines Agency that require us to take a position on their use and to update certain elements of the recommendations. The first important message concerns the position of the French Headache Society on the use of preventive treatments (monoclonal antibodies and gepants) targeting the calcitonin gene-related peptide (CGRP) pathway. In terms of efficacy and safety, and as suggested by other national headache societies, these treatments can be offered as first-line treatment, although the scope defined by the French national health authority for possible reimbursement is limited to patients with severe migraine, at least eight headache days per month and for whom two previous preventive treatments have failed. Another important change concerns the position of topiramate as a preventive treatment for migraine in women of childbearing age. This treatment has been proposed as a first-line treatment for chronic migraine. However, recent pharmacovigilance data have highlighted a potential adverse effect on neurodevelopment in children exposed in utero. As a result, this treatment is formally contraindicated during pregnancy and must be used with extreme caution in women of childbearing age (effective contraception, no therapeutic alternative available and annual follow-up as with valproate). It can therefore no longer be offered as first-line treatment for women of childbearing age.

News (Medical) associated with Atogepant

26 Dec 2024

·www.drugs.com

Atogepant Superior for Efficacy, Functional Measures in Migraine

THURSDAY, Dec. 26, 2024 -- For adults with migraine , atogepant 60 mg once daily was superior to placebo for efficacy and functional measures of treatment across three trials, according to research published online Dec. 23 in Neurology . Richard B. Lipton, M.D., from the Albert Einstein College of Medicine in Bronx, New York, and colleagues examined improvements in efficacy and functional outcomes in the first four weeks of treatment with atogepant 60 mg once daily for the preventive treatment of migraine. The atogepant and placebo treatment arms from three phase 3, multicenter, randomized trials were included (ADVANCE [222 participants with episodic migraine receiving atogepant and 214 receiving placebo]; ELEVATE [151 participants with episodic migraine receiving atogepant and 154 receiving placebo]; and PROGRESS [256 participants with chronic migraine receiving atogepant and 246 receiving placebo]). The researchers observed greater reductions in the proportion of atogepant-treated participants with a migraine day on day 1. Compared with placebo, the odds ratios were 0.39, 0.53, and 0.63 in ADVANCE, ELEVATE, and PROGRESS, respectively. Reductions in weekly migraine days at weeks 1 to 4 and in monthly migraine days in the first four weeks were seen with atogepant treatment; in addition, at all assessed time points for weeks 1 to 4, Activity Impairment in Migraine-Diary and European Quality-of-Life 5-Dimension 5-Level scores improved compared with placebo. "The analyses reported here demonstrate the early efficacy and functional improvements of atogepant and address a key unmet need of providing preventive treatment options with early benefits across the spectrum of migraine disease state severity," the authors write. Several authors disclosed ties to pharmaceutical companies, including AbbVie, which manufactures atogepant and funded the study. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3

26 Dec 2024

·www.drugs.com

Quick Fix? New Migraine Medicine May Start Working Right Away

THURSDAY, Dec. 26, 2024 -- Migraine patients often suffer a long time before docs zero in on the best dosage for drugs designed to prevent their terrible symptoms. But a recently approved daily migraine pill called Qulipta ( atogepant ) appears to be effective from day one in many patients, clinical trial data shows. Patients taking Qulipta had a 37% to 61% lower risk for experiencing migraine from the very first day they started taking the drug, according to a new report in the journal Neurology . “With many current drugs to prevent migraine, it takes time to find the right dosage for the individual and it can take weeks or even months for it to be most effective,” lead researcher Dr. Richard Lipton , vice chair of neurology with the Albert Einstein College of Medicine in the Bronx, NY, said in a news release. “Some people give up and stop taking the drugs before they reach this point. Plus, many people experience side effects with current treatments. Developing a drug that works both effectively and quickly is critical,” Lipton continued. The U.S. Food and Drug Administration (FDA) approved Qulipta in Sept. 2021. It works by blocking calcitonin gene-related peptide (CGRP), a protein released by the brain’s nerve cells during a migraine attack. For this new study, researchers analyzed results from three prior clinical trials for atogepant to see how quickly patients tended to get relief from the drug. Two of the trials, ADVANCE and PROGRESS, tested the drug in patients with episodic or chronic migraine, respectively. Episodic migraine involves 14 or fewer attack days per month, while chronic migraine involves 15 or more. The third trial, ELEVATE, tested atogepant in people with episodic migraine who hadn’t been helped by other migraine medicines, such as triptans. Results from the three trials showed: Atogepant patients also showed less daily impairment from migraine and overall better quality of life, compared to people taking placebo, results show. “Migraine is the second-leading cause of disability in the overall population and the leading cause of disability in young women, with people reporting negative effects on their relationships, parenting, career and finances,” Lipton said. “Having a treatment that can act quickly and effectively addresses a key need,” Lipton added. This new evidence review was funded by AbbVie, the maker of Qulipta. Qulipta and other CGRP-blocking drugs tend to be much more expensive than older migraine drugs, according to the Association of Migraine Disorders. A 30-day supply of Qulipta costs about $1,160 without insurance or discounts, according to Drugs.com . By comparison, generic triptans can cost as low as $12 a month. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug Approval

26 Dec 2024

·www.drugs.com

Quick Fix? New Migraine Medicine, Qulipta, May Start Working Right Away

THURSDAY, Dec. 26, 2024 -- Migraine patients often suffer a long time before docs zero in on the best dosage for drugs designed to prevent their terrible symptoms. But a recently approved daily migraine pill called Qulipta ( atogepant ) appears to be effective from day one in many patients, clinical trial data shows. Patients taking Qulipta had a 37% to 61% lower risk for experiencing migraine from the very first day they started taking the drug, according to a new report in the journal Neurology . “With many current drugs to prevent migraine, it takes time to find the right dosage for the individual and it can take weeks or even months for it to be most effective,” lead researcher Dr. Richard Lipton , vice chair of neurology with the Albert Einstein College of Medicine in the Bronx, NY, said in a news release. “Some people give up and stop taking the drugs before they reach this point. Plus, many people experience side effects with current treatments. Developing a drug that works both effectively and quickly is critical,” Lipton continued. The U.S. Food and Drug Administration (FDA) approved Qulipta in Sept. 2021. It works by blocking calcitonin gene-related peptide (CGRP), a protein released by the brain’s nerve cells during a migraine attack. For this new study, researchers analyzed results from three prior clinical trials for atogepant to see how quickly patients tended to get relief from the drug. Two of the trials, ADVANCE and PROGRESS, tested the drug in patients with episodic or chronic migraine , respectively. Episodic migraine involves 14 or fewer attack days per month, while chronic migraine involves 15 or more. The third trial, ELEVATE, tested atogepant in people with episodic migraine who hadn’t been helped by other migraine medicines, such as triptans. Results from the three trials showed: Atogepant patients also showed less daily impairment from migraine and overall better quality of life, compared to people taking placebo, results show. “Migraine is the second-leading cause of disability in the overall population and the leading cause of disability in young women, with people reporting negative effects on their relationships, parenting, career and finances,” Lipton said. “Having a treatment that can act quickly and effectively addresses a key need,” Lipton added. This new evidence review was funded by AbbVie, the maker of Qulipta. Qulipta and other CGRP-blocking drugs tend to be much more expensive than older migraine drugs, according to the Association of Migraine Disorders. A 30-day supply of Qulipta costs about $1,160 without insurance or discounts, according to Drugs.com . By comparison, generic triptans can cost as low as $12 a month. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultDrug Approval

100 Deals associated with Atogepant

External Link

KEGG	Wiki	ATC	Drug Bank
D11313	Atogepant	-	DB16098

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	AbbVie, Inc.	28 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Migraine Disorders	Phase 2	RU	Allergan Ltd. (Ireland)	11 Mar 2019
Acute migraine	IND Approval	CN	AbbVie, Inc.	25 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05264129 (TANDEM, CTgov)	Phase 4	Migraine Disorders	263	Atogepant (Atogepant 60 mg (Period 1))	ttajvyeyxg(rlpthbzjpg) = cvaoyknqcr zgsmotpvsc (fsdtgvbqpf, uxmacbmkjq - yeheuwhdkj) View more	-	08 Oct 2024
				Atogepant+Ubrogepant (Atogepant 60 mg + Ubrogepant 100 mg (Period 2))	ttajvyeyxg(rlpthbzjpg) = blvoeyzddr zgsmotpvsc (fsdtgvbqpf, ydwleurnrk - ukduagnvir) View more
NCT03855137 (PROGRESS, Pubmed)	Phase 3	Migraine Disorders	755	Atogepant 30 mg BID	(zjzullvdeb) = ghwyvhmtgx ctypoomvqi (cjqfsjlvih, -4.0 to -1.5) View more	Positive	23 Jul 2024
EAN2024	Not Applicable	-	-	Atogepant 10 mg	vzamsmnawa(txtasurkvb) = jhjwswewos uefymujsfj (kkbuqqpjey )	-	28 Jun 2024
				Atogepant 30 mg	vzamsmnawa(txtasurkvb) = minxfhiwdz uefymujsfj (kkbuqqpjey )
NCT03777059 \| NCT03700320 (ADVANCE, Pubmed)	Phase 3	Migraine Disorders calcitonin gene-related peptide receptor	-	Atogepant 10 mg	xvvvarafjj(dvgicyijbt) = qntvsfmszw okeajpvlev (bsnxqvyzwt ) View more	Positive	21 May 2024
				Atogepant 30 mg	xvvvarafjj(dvgicyijbt) = eftpnztmcg okeajpvlev (bsnxqvyzwt ) View more
NCT04740827 \| NCT03855137 \| NCT04686136 (3101-312-002, PRNewswire) Manual	Phase 3	Migraine Disorders	-	Atogepant 60 mg	(oijgpqnxdp) = ywlekjvnpk fwujjxzwdb (ltkcmffdrg ) View more	Positive	12 Apr 2024
NCT05264129 (TANDEM, AAN2024)	Phase 4	Migraine Disorders \| Acute migraine calcitonin gene-related peptide (CGRP) receptor antagonist	263	Atogepant 60mg QD	tcsvnotqcx(urreredyxl) = 8.4% vs 3.2% bgxtswbpxz (apnsppvvoq ) View more	Positive	09 Apr 2024
				Ubrogepant 100mg PRN
P4-12.008 (AAN2024)	Not Applicable	Migraine Disorders calcitonin gene-related peptide	-	Atogepant	byfunqmbxm(xbeemkzdtc) = zsitwlzzdt daodvdieps (knchfnunua )	Negative	09 Apr 2024
				CGRP mAbs (eptinezumab, erenumab, fremanezumab, galcanezumab)	byfunqmbxm(xbeemkzdtc) = gyngxrumon daodvdieps (knchfnunua )
AAN2024	Not Applicable	Migraine Disorders	-	Atogepant 60 mg QD	(dbqeypkyyk): OR = 2.23 (95% CI, 1.4 - 3.55)	-	09 Apr 2024
				Placebo
NCT03777059 \| NCT03939312 \| NCT03700320 \| NCT02848326 (Pubmed \| J Headache Pain)	Phase 2/3	Migraine Disorders	1,550	Atogepant	(jsigpqzimb) = xttexhordy tipjerneek (udjjnkosyu ) View more	Positive	11 Mar 2024
				Placebo	(jsigpqzimb) = tzlqkrquyl tipjerneek (udjjnkosyu ) View more
NCT04740827 (ELEVATE, CTgov)	Phase 3	Migraine Disorders	315	Placebo (Placebo)	kqqfhgdvql(bndqrhpyif) = gadujgwiuc nogqpmonqd (kxploghlqt, biuchzcjlw - quycmnluad) View more	-	21 Sep 2023
				Atogepant 60 mg (Atogepant 60 mg)	kqqfhgdvql(bndqrhpyif) = wxnhuqixjw nogqpmonqd (kxploghlqt, nzacnvjatf - omgdmycjhq) View more

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