Migraine

FDA approval · 2025-02-26

FDA Approved: DIHYDROERGOTAMINE MESYLATE — Original Application (Somerset Therapeutics, LLC)

FDA approved Somerset Therapeutics, LLC's generic dihydroergotamine mesylate under an original ANDA for the acute treatment of migraine.

CLINICAL_TRIALS trial_result · 2025-02-25

Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine [Phase 2]

Phase 2 study evaluating the efficacy and safety of TNX-1900 in chronic migraine has completed and results have been posted.

CLINICAL_TRIALS trial_result · 2025-02-24

Clinical Trial Update: Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg Vs Placebo As Adjuvant Treatment in Chronic Migraine - [Phase 2, Phase 3]

A Phase 2/Phase 3 trial evaluating a CBD/CBG/THC combination as adjuvant therapy for chronic migraine and related headaches was terminated.

CLINICAL_TRIALS trial_result · 2025-02-20

Clinical Trial Update: A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants [Phase 3]

Phase 3 study evaluating the long-term safety of rimegepant for acute treatment of migraine in Chinese participants has completed. Results h…

CLINICAL_TRIALS trial_result · 2025-02-19

Clinical Trial Update: Comparison of Neuromodulatory Treatment of Migraine Headache with Acupuncture and Transcranial Direct Current Stimulation [NA]

A clinical trial comparing acupuncture to transcranial direct current stimulation for migraine is currently enrolling by invitation.

CLINICAL_TRIALS trial_result · 2025-02-14

Clinical Trial Update: Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine [Phase 3]

A Phase 3 clinical trial evaluating the efficacy and safety of rizatriptan-naproxen (10/550 mg) for the acute treatment of migraine has been…

FDA approval · 2025-02-11

FDA Approved: ZOLMITRIPTAN OD — Supplemental Application (Jubilant Cadista Pharmacuticals Inc.)

FDA approved a supplemental application to authorize Zolmitriptan Oral Disintegrating Tablet (OD) for acute treatment of migraine, manufactu…

CLINICAL_TRIALS research · 2025-02-11

Clinical Trial Update: Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG [NA]

A prospective exploratory clinical trial is evaluating MEG-guided repetitive transcranial magnetic stimulation (rTMS) for migraine and is cu…

CLINICAL_TRIALS trial_result · 2025-02-10

Clinical Trial Update: Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only) [Phase 3]

A Phase 3 study in Japanese adults evaluated the efficacy and safety of rimegepant (Nurtec ODT) for acute treatment of migraine; results hav…

CLINICAL_TRIALS trial_result · 2025-02-10

Clinical Trial Update: Hydration in Children and Adolescents With Primary Headaches [NA]

This clinical trial update reports the completion of a study evaluating whether hydration benefits children and adolescents with primary hea…

CLINICAL_TRIALS trial_result · 2025-02-06

Clinical Trial Update: Work-related Burden Changes, Quantified with HEADWORK, Among Individuals Treated with Migraine Preventive Therapies.

This trial update reports changes in work-related burden among people treated with migraine preventive therapies, as measured by the HEADWOR…

CLINICAL_TRIALS trial_result · 2025-01-31

Clinical Trial Update: A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine [Phase 3]

A Phase 3 randomized, double-blind, placebo-controlled study of fremanezumab in Chinese adults with migraine has completed, including an ope…

FDA approval · 2025-01-30

FDA Approved: SYMBRAVO — Original Application (Axsome Therapeutics, Inc.)

FDA approved SYMBRAVO, a fixed-dose combination of meloxicam and rizatriptan from Axsome Therapeutics, under an original NDA for the acute t…

CLINICAL_TRIALS trial_result · 2025-01-29

Clinical Trial Update: Examination of Muscle Stiffness, Tenderness and Pressure Pain Thresholds During a Cycle of Botulinum Toxin A Treatment in Chronic Migraine Patients

A completed study examining muscle stiffness, tenderness, and pressure pain thresholds during Botulinum toxin A treatment in chronic migrain…

CLINICAL_TRIALS trial_result · 2025-01-29

Clinical Trial Update: Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain. [NA]

This update reports the completed clinical trial results for a mind-body based digital application intended to treat chronic pain and migrai…

CLINICAL_TRIALS research · 2025-01-29

Clinical Trial Update: Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment

An update on a study assessing autonomic dysfunction in patients with migraine, including cardiovascular and neurophysiological measurements…

CLINICAL_TRIALS research · 2025-01-27

Clinical Trial Update: Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old [Phase 4]

This is a Phase 4 clinical trial update for preventing migraines in children aged 6 to 11 using Qudexy XR (topiramate extended-release); the…

FDA approval · 2025-01-23

FDA Approved: DEPAKOTE ER — Supplemental Application (AbbVie Inc.)

FDA approved a supplemental application for Depakote ER (divalproex sodium) submitted by AbbVie Inc.