CAT-Trial: CGRP Monoclonal Antibody for Treatment of Painful Diabetic Neuropathy: a Double-blind, Randomized, Placebo-controlled, International Multicenter, Phase II Clinical Trial

The main purpose of this study is to compare the change in pain intensity during treatment with a CGRP monoclonal antibody (eptinezumab) compared with placebo treatment in patients with painful diabetic polyneuropathy (DPN).

Start Date01 Jan 2025

Sponsor / Collaborator

Mayo Clinic

NCT06701526

/ RecruitingPhase 4

Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

Start Date18 Dec 2024

Sponsor / Collaborator

H. Lundbeck A/S

NCT06628921

/ Not yet recruitingNot Applicable

The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study

A perspective and multicentric study to evaluate the efficacy of eptinezumab administered during a migraine attack. During the intravenous infusion of eptinezumab, some patients experiencing an ongoing migraine attack report its resolution. This finding is known in the literature, having been described in the RELIEF study. This study was designed to also evaluate, in a real-world setting, the efficacy of eptinezumab in resolving the ongoing attack and the time frame within which the attack is resolved.
The study includes all patients who will begin treatment according to clinical practice, and are included in the TACHIS study (NCT06409845, Unique protocol ID RICe_5)

Start Date30 Oct 2024

Sponsor / Collaborator

University of Florence

[+1]

100 Clinical Results associated with Eptinezumab-JJMR

100 Translational Medicine associated with Eptinezumab-JJMR

100 Patents (Medical) associated with Eptinezumab-JJMR

207

Literatures (Medical) associated with Eptinezumab-JJMR

01 Jan 2025·Headache: The Journal of Head and Face Pain

Long‐term reductions in acute headache medication use after eptinezumab treatment in patients with migraine and prior preventive treatment failures: Post hoc analysis of the DELIVER randomized trial

Article

Author: Ashina, Messoud ; Gryglas‐Dworak, Anna ; Ettrup, Anders ; Josiassen, Mette Krog ; Ranc, Kristina ; Boserup, Line Pickering ; Sperling, Bjørn ; Schim, Jack

AbstractObjectiveTo evaluate long‐term reductions in acute headache medication (AHM) use with eptinezumab versus placebo in patients with prior preventive migraine treatment failures and medication overuse (MO).BackgroundPreventive migraine treatment is recommended for patients for whom AHMs have failed and for those who are using excessive amounts of AHM. MO may worsen headache and migraine symptoms in people with migraine; it is a risk factor for disease chronification and/or MO headache.MethodsDELIVER was a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, phase 3b clinical trial that randomized adults with migraine and two to four prior preventive failures to eptinezumab 100 mg, 300 mg, or placebo infusion every 12 weeks; patients initially given placebo received eptinezumab 100 mg or 300 mg in the extension period. MO was defined according to diagnostic criteria for MO headache in the baseline diary reports. This post hoc analysis of the DELIVER study included change from baseline in AHM days/month of use (ergotamines, triptans, simple or combination analgesics, and opioids; total and select class‐specific use) in the MO population.ResultsA total of 890 patients were included in the total population, and 438/890 (49.2%) had MO at baseline. In both the total population and MO population, eptinezumab resulted in greater reductions in total AHM days/month of use during weeks 1–24 than placebo, with triptans showing the largest reduction among AHM classes. Patients switching from placebo to eptinezumab experienced reductions in AHM days/month similar to that of initial eptinezumab treatment. In the extension population, mean (standard error [SE]) changes from baseline in AHM days/month were −4.6 (0.32; 100 mg) and −4.8 (0.32; 300 mg) across weeks 1–4 in patients who received eptinezumab for the entire treatment period and were −4.8 (0.44; placebo–100 mg) and −5.5 (0.44; placebo–300 mg) across weeks 25–28 in patients who switched from placebo to eptinezumab. Mean (SE) changes from baseline in AHM days/month in the extension MO population were −6.5 (0.59; 100 mg) and −6.6 (0.57; 300 mg) across weeks 1–4 in patients who received eptinezumab for the entire treatment period and were −7.1 (0.81; 100 mg) and −8.0 (0.80; 300 mg) across weeks 25–28 in patients who were switched from placebo to eptinezumab. All treatment arms sustained or further reduced AHM use across 18 months of trial participation. Across weeks 1–4, in patients fulfilling criteria for MO at baseline, 68.0% (102/150) of patients treated with eptinezumab 100 mg and 74.7% (109/146) of patients treated with eptinezumab 300 mg reported AHM use below MO thresholds compared to 43.3% (61/141) of patients receiving placebo. In patients with MO at baseline, the proportion of patients without MO remained above 60.0% for all treatment groups during the extension period.ConclusionsEptinezumab reduced total AHM use more than placebo in patients with prior preventive failures and in patients with MO at baseline; largest reductions were observed for triptans. Robust reductions in AHM use after eptinezumab were sustained or further reduced with up to 18 months of treatment, and most patients no longer met thresholds for MO.

01 Jan 2025·Journal of Neurology

Eptinezumab treatment was associated with longer interictal headache/migraine periods which corresponded to greater improvements in patient-reported quality of life measures

Article

Author: Asher, Divya ; Hirman, Joe ; Tepper, Stewart J ; Cady, Roger ; Fiore, Damian ; Diamond, Merle L

AbstractIntroductionLonger periods between headache episodes (interictal periods) may provide greater time for the nervous system to reset from a previous episode, potentially improving disease status and health-related quality of life. This post hoc analysis evaluated this hypothesis by associating patients’ longest interictal periods with improvements in patient-reported outcomes.MethodsPROMISE-2 (NCT02974153) was a double-blind, placebo-controlled study evaluating eptinezumab for preventive treatment of chronic migraine (N = 1072). Daily electronic diary data from Weeks 1–12 and Weeks 1–24 were used to identify interictal periods, defined as days between headache episodes. For each patient, the longest interictal period within these intervals was identified and categorized (1–4, 5–9, 10–14, > 14, and > 21 days). For each category, the following patient-reported outcomes were assessed: 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS).ResultsExcluding interictal periods with > 10% missing data (resulting in 1010 patients with sufficient data), the mean (SD) of longest interictal periods over Weeks 1–12 was 9.4 (11.0) days. A ≥6-point HIT-6 reduction was observed in 78% (56/72) vs 26% (91/351) of patients with a > 21-day vs 1–4-day longest interictal period, respectively; much or very much improvement per PGIC was reported in 90% (65/72) vs 25% (87/348), respectively, and per PI-MBS was reported in 88% (63/72) vs 26% (92/348), respectively. Similar results were observed for Weeks 1–24.ConclusionLonger interictal periods were associated with more patients indicating positive changes in headache-related life impact, disease status, and symptomology.Trial registration: ClinicalTrials.gov (identifier: NCT02974153; registered: 2016-11-23)

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 Eptinezumab-JJMR

14 Oct 2024

·endpts.com

Lundbeck makes $2.6B cash move for Longboard a month after starting Phase 3 in Dravet syndrome

Danish drugmaker Lundbeck will buy La Jolla, CA-based Longboard Pharmaceuticals for $2.6 billion in cash, the companies said Monday morning, marking the largest biopharma M&A deal since July . Neuroscience-focused Lundbeck will get access to a 5-HT2C superagonist that just entered Phase 3 last month for Dravet syndrome, a severe type of epilepsy found in infancy. The experimental medicine, known as bexicaserin, could also apply to other developmental and epileptic encephalopathies like Lennox-Gastaut syndrome and CDKL5 deficiency disorder, the company has said. Lundbeck projects a launch of bexicaserin in the last quarter of 2028 and global peak sales potential of up to $2 billion. The drugmaker also gets an S1P receptor modulator dubbed LP659 that is in Phase 1 and could be tested in multiple neurological diseases. Lundbeck CEO Charl van Zyl said Longboard will “become a cornerstone in Lundbeck’s neuro-rare franchise.” “Bexicaserin addresses a critical unmet need for patients suffering from rare and severe epilepsies, for which there are very few good treatment options available,” van Zyl said in a statement. Longboard spun out of Arena Pharmaceuticals with $56 million in October 2020. It went public five months later. Pfizer then bought Arena for $6.7 billion in December 2021. The deal comes amid a relatively dull past few months for public biopharma M&A, with many of the recent deals falling below $1.3 billion. There has been no deal of $5 billion or higher yet in 2024. Lundbeck itself has been relatively quiet on the acquisition front since its $1.95 billion Alder BioPharmaceuticals deal in September 2019. That led to a migraine drug approval a few months later for Vyepti . The Longboard deal is slated to close this quarter, and both boards have approved it, the companies said. Longboard will be bought for $60 per share $LBPH . Its share price skyrocketed 50% to $58 in premarket trading.

AcquisitionDrug ApprovalPhase 3Phase 1

19 Sep 2024

·www.fiercepharma.com

New migraine drugs less effective than previous generation of triptan meds: BMJ study

A meta-analysis of 137 trials of migraine drugs indicates that the newest class of treatments are less effective than the previous generation of triptan drugs in relieving acute headaches. A study from The BMJ indicates that the newest class of migraine drugs—which includes Pfizer’s Nurtec, AbbVie’s Ubrelvy and Eli Lilly’s Reyvow—is less effective in the acute treatment of migraines than a previous class of medicines.What's more, the newer drugs are no more effective in treating migraines than traditional headache remedies such as Tylenol, ibubrofen and aspirin, according to The BMJ's analysis.The study, a meta-analysis of 137 trials that together enrolled nearly 90,000 patients, indicates that the most effective treatments for migraine come from the triptan class. In head-to-head comparisons of the 17 drugs covered in the study, triptans demonstrated the best efficacy within 2 hours of use, led by eletriptan, which also delivered the best-sustained relief over 24 and 48 hours, according to the analysis.Eletriptan was brought to the market by Pfizer in 2002 and sold under the brand name Relpax. The next most effective medicines in providing relief at 2 hours were the following triptans (in order of performance): rizatriptan, sumatriptan and zolmitriptan. Rizatriptan is sold by Organon as Maxalt. GSK sells sumatriptan as Imitrex and AstraZeneca markets zolmitriptan as Zomig.“Triptans are currently widely underused, and access to the most effective triptans should be promoted globally and international guidelines updated accordingly,” the authors wrote. The BMJ analysis also concluded that the newest class of migraine treatments—which are called calcitonin gene-related peptide receptor (CGRP) antagonists—should only be used after traditional headache meds.“While the recent introduction of lasmiditan (Reyvow), rimegepant (Nurtec), and ubrogepant (Ubrelvy) has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan, suggest their use as third-line options, after the less expensive, similarly efficacious, second-line options," the authors wrote.While the BMJ study focused on acute treatment of migraines, new CGRP treatments have also been approved as preventatives. Nurtec pills, for example, were approved in 2021 for use every other day to ward off potential migraines. Much hope has been pinned on the effectiveness of CGRP drugs. In 2022, Pfizer spent $11.6 billion in a buyout of Biohaven to gain Nurtec, which rolled up sales of $928 million last year. Meanwhile, Ubrelvy, which was approved in 2019, generated $815 million in sales.Several other CGRPs—all approved in 2018 for the prevention of migraines—also remain formidable. Eli Lilly’s Emgality generated $678 million in sales last year, while Teva’s Ajovy pulled in $435 million and Amgen’s Aimovig collected $303 million. Besides those drugs, Lundbeck's Vyepti won approval in 2020 and generated about $250 million last year.

Drug ApprovalAcquisitionClinical Result

18 Jul 2024

·firstwordpharma.com

Teva touts first CGRP success in Phase III paediatric migraine prevention study

Teva is looking to expand its migraine prevention portfolio into the paediatric market, announcing positive results Thursday from the Phase III SPACE study evaluating Ajovy (fremanezumab) in children and adolescents. According to Teva, this is the first time an anti-CGRP monoclonal antibody has shown efficacy in this population.Teva estimates that migraines affect about 7.7% of children, with prevalence rising from 5% in kids aged 5 to 10 to around 15% in teenagers. "The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them," said Chief Medical Officer Eric Hughes.The trial randomised 235 subjects between the ages of 6 and 17 years to receive subcutaneously administered Ajovy or placebo over a 12-week period to prevent episodic migraines. Teva said the study met its primary endpoint, with Ajovy patients experiencing significantly fewer monthly migraine days compared to placebo."The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations," the company said.So far, all other CGRP antibodies in the US — Amgen's Aimovig (erenumab), Lundbeck's Vyepti (eptinezumab) and Eli Lilly's Emgality (galcanezumab) — are only approved for adults. Ajovy was greenlit in the US as a preventative migraine treatment for adults in 2018 and was later also cleared in Europe.Amgen and Lundbeck are also testing their respective products in paediatric patients with chronic or episodic migraine. Aimovig is being evaluated in Amgen's OASIS(EM) and OASIS(CM) studies, both due to complete in 2027, while Vyepti is being investigated in the Phase III PROSPECT-1 and PROSPECT-2 trials, which are expected to wrap up towards the end of this year.Teva noted that the efficacy seen in the SPACE study was "consistent" with pivotal Phase III and real-world evidence in adults. No new emergent safety signals emerged. Full data will be presented at a medical meeting later this year.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Eptinezumab-JJMR

External Link

KEGG	Wiki	ATC	Drug Bank
-	Eptinezumab-JJMR	L01XC	DB14040

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Migraine Disorders	US	Lundbeck Seattle BioPharmaceuticals, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cluster Headache	Phase 3	IT	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	NO	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	GR	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	FI	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	PT	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	DE	H. Lundbeck A/S	23 Dec 2020
Cluster Headache	Phase 3	EE	H. Lundbeck A/S	23 Dec 2020
Acute migraine	Phase 1	US	H. Lundbeck A/S	07 Nov 2019
Acute migraine	Phase 1	GE	H. Lundbeck A/S	07 Nov 2019
Migraine Disorders	Phase 1	UA	Lundbeck Seattle BioPharmaceuticals, Inc.	01 Nov 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02974153 (PROMISE-2, Pubmed \| J Neurol)	Phase 3	Migraine Disorders \| Headache	1,072	Eptinezumab	tooilcgmxu(ukfrxfqzyd) = gpkkwyyffi dbhnvrzshl (hetomizvkr ) View more	-	01 Jan 2025
				Placebo	tooilcgmxu(ukfrxfqzyd) = odvnmmtihc dbhnvrzshl (hetomizvkr ) View more
NCT04688775 (ALLEVIATE, CTgov)	Phase 3	Cluster Headache	231	Eptinezumab (Eptinezumab)	nlnulrilko(quqowebgrx) = pfhgbjiswf bkpvdstxwq (avvomxfdss, yeqmltzodp - nguwjcjdvg) View more	-	09 Aug 2024
				placebo+eptinezumab (Placebo)	nlnulrilko(quqowebgrx) = tkmtsauadi bkpvdstxwq (avvomxfdss, nehpevekki - gmppfoyupj) View more
NCT05064397 (CHRONICLE, CTgov)	Phase 3	Cluster Headache	131	Eptinezumab	uyklfsnjjd(vuzuymcqwg) = dnnaiinwnn mfclnsmdeu (umwfvmzgrd, tussgvwnyl - qzfqqyfkcx) View more	-	06 Aug 2024
NCT05284019 (EVEC, CTgov)	Phase 4	Migraine Disorders	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	kacarwwxyd(ysnapvyksv) = pffdwoaxvx ebdpnsglwx (qfdopcucbl, ebtauleghm - aifbvucsxk) View more	-	29 May 2024
				Eptinezumab (Eptinezumab)	kacarwwxyd(ysnapvyksv) = osyehijeod ebdpnsglwx (qfdopcucbl, ckrvdhvesk - uucvwimygj) View more
REVIEW (AAN2024)	Not Applicable	Migraine Disorders	-	Eptinezumab	ikfqwejmmz(ndhitrprut) = vfafsxlfbu wupdgsofuz (bjqqdwpxsf ) View more	Positive	09 Apr 2024
REVIEW (AAN2024)	Not Applicable	Migraine Disorders	94	Eptinezumab (Patients with psychiatric conditions)	kwfqdvqsox(gtbtmnfoto) = maqovnttwl lbxbpkkqdw (ujizpfnmws ) View more	Positive	09 Apr 2024
				Eptinezumab (Patients without psychiatric conditions)	kwfqdvqsox(gtbtmnfoto) = smsrjccevo lbxbpkkqdw (ujizpfnmws ) View more
NCT02974153 (PROMISE-2, AAN2023)	Phase 3	Migraine Disorders \| Headache Disorders, Secondary	1,072	Eptinezumab 100mg	ycjidpckki(pubmqgoobz) = osvbigowjg bdugniwgjp (aywrtparpr ) View more	Positive	25 Apr 2023
				Eptinezumab 300mg	ycjidpckki(pubmqgoobz) = ifbbzjvzpn bdugniwgjp (aywrtparpr ) View more
AAN2023	Not Applicable	-	31	Eptinezumab 100mg	zutttmmreu(wlxxjmpsbw) = 77.4% reported that treatment improved disability/function after 6 months of use sxkwttadkr (igcoflwgka ) View more	Positive	25 Apr 2023
P10-12.001 (AAN2023)	Not Applicable	Migraine Disorders calcitonin gene-related peptide (CGRP)	-	Eptinezumab	nlfvdtmgpu(dekbrjohlr) = swpnhbanct pcozesfiva (blvffdoozl )	Positive	25 Apr 2023
NCT04418765 (DELIVER, AAN2023)	Phase 3	Migraine Disorders	890	Eptinezumab 100mg	(vwapqraikl) = wgycbsfozc stezmepxft (nzatkxdjgx )	-	25 Apr 2023
				Eptinezumab 300mg	(vwapqraikl) = asirgezadm stezmepxft (nzatkxdjgx )

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