NCT05492695 (TOGETHER) is a Phase 4 clinical trial of Galcanezumab in Migraine, sponsored by Diamond Headache Clinic.

Who is sponsoring NCT05492695?

NCT05492695 is sponsored by Diamond Headache Clinic.

What drugs are being tested in NCT05492695?

Interventions in NCT05492695: Galcanezumab, Placebo.

Is NCT05492695 still recruiting?

NCT05492695 is currently terminated. Last updated 29 September 2023.

Last reviewed 2023-09-29 · How we verify

NCT05492695: TOGETHER

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

Terminated Phase 4 Last updated 29 September 2023

What this trial tests

Phase 4 trial testing Galcanezumab in Migraine in 2 participants. Terminated before completion.

Timeline

1 October 2022

Primary endpoint
28 September 2023

28 September 2023

Quick facts

Lead sponsor	Diamond Headache Clinic
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	2
Start date	1 October 2022
Primary completion	28 September 2023
Estimated completion	28 September 2023
Sites	1 location across United States

Drugs / interventions tested

Galcanezumab (GALCANEZUMAB) — full drug profile →
Placebo

Conditions studied

Migraine — all drugs for Migraine →

Sponsor

Diamond Headache Clinic

Who can join

Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Galcanezumab

Trials testing the same drug.

NCT07323927 — Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease · EARLY_PHASE1 · recruiting
NCT05281770 — Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study · unknown
NCT05284019 — Real World Effectiveness of Eptinezumab in Participants With Migraine · Phase 4 · terminated
NCT05127486 — A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine · Phase 4 · completed
NCT04294147 — A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antag · Phase 4 · completed

Other recruiting trials for Migraine

Currently open trials in the same condition.

NCT07419607 — MIGRAFIT: Evaluating a Group Therapy Program Combining Physical Activity, Progressive Muscle Relaxation and Psychoeducat · NA · recruiting
NCT07487701 — Migraine Prevention With the Remote Electrical Neuromodulation (REN) Wearable: A Real-world Evidence Study · NA · active not recruiting
NCT07343427 — Impact of GON PRF on Central Sensitization in Migraine Patients · NA · active not recruiting
NCT07336056 — Nerivio Efficacy Under High-Frequency Use · Phase 4 · active not recruiting
NCT07385755 — Desvenlafaxine for Preventive Treatment of Frequent Migraines · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05492695 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Diamond Headache Clinic
Last refreshed: 29 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05492695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing