AzTrials
AzTrials

MigraineGARLITNCT04803513

Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly

An observational study of Migraine, run by Campus Bio-Medico University at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: To determine in real life the efficacy, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic (CM) migraine. Design: This prospective observational cohort study was conducted between November 2019 and January 2021. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
Galcanezumab
How many people
300 participants
Where
1 siteItaly
Study dates
1 Nov 2019to 31 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients aged 18 or older with a diagnosis of high-frequency episodic migraine (8-14 migraine days per month) or chronic migraine (1.3 ICHD-3),

Who may be able to join

  • the clinical indication for Galcanezumab as a preventive treatment for Migraine according to European Medicines Agency
  • age18 years or older
  • 8 or more mean Monthly Migraine Headache days in the last three months

Who cannot join

  • previous exposure to any monoclonal antibodies inhibiting CGRP pathway, including clinical trials

Trial locations and contacts

1 site in 1 country.

Fabrizio Vernieri, MD contact

003922541 ext. 1889

f.vernieri@unicampus.it

Claudia Altamura, MD PhD contact

003962251 ext. 1270

c.altamura@unicampus.it

Italy1 site, 1 recruiting

  • Campus Bio Medico University Hospital

    Rome, RM, 00122

    Fabrizio Vernieri, MD, +3906 ext. 1889, c.altamura@gmail.com

    Recruiting

Other trials in Italy

About this study

Official title: Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly (GARLIT)

Objective: To determine in real life the efficacy, safety and tolerability of galcanezumab in the prevention of high-frequency episodic migraine (HFEM) and chronic (CM) migraine.

Design: This prospective observational cohort study was conducted between November 2019 and January 2021.

Read more

Participants: Consecutive adult HFEM and CM patients clinically prescribed galcanezumab were enrolled.

Setting: Multicenter study in 13 Italian headache centers.

Exposure: Galcanezumab subcutaneous injection 120 mg monthly with the first loading dose of 240 mg.

Main Outcome(s) and Measure(s): The primary end-point was the change in monthly migraine days (MMDs) in HFEM patients and monthly headache days (MHDs) in CM ones after six months of therapy (V6) compared to baseline. Secondary end-points included variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI), HIT-6, and MIDAS scores. We assessed 50%, 75%, and 100% responder rates (RR), the conversion rate from CM to episodic migraine (EM), and the Medication Overuse condition to the non-overuser.

Read the detailed description

GARLIT is an independent, multicenter, prospective, cohort, real-life study. All consecutive patients aged 18 or older with a diagnosis of HFEM (8-14 migraine days per month) or CM (1.3 ICHD-3), who had failed at least three migraine preventive treatments and not previously involved in any CGRP mAbs trial, are considered for enrolment. Patients are assessed at baseline by a headache expert neurologist with a face-to-face interview using a semi-structured questionnaire addressing socio-demographic factors, clinical migraine features, previous and current acute and preventive migraine treatments, comorbidities and concomitant medications. Headache-related dopaminergic and autonomic symptoms, temporal artery turgidity/hyperpulsatility, and allodynia during or between attacks are also investigated. Patients are also requested to rate the overall efficacy of triptans in most attacks as none/poor (0) or fair/excellent (1).

Enrolled patients will carefully fill in a headache diary during a run-in month period (baseline) and the entire duration of the study, to report monthly migraine days (MMDs) for HFEM patients, all monthly headache days (MHDs) of at least moderate intensity for CM subjects, and monthly painkillers intake (MPI). Patients were also asked to rate pain severity (using the 0-10 Numerical Rating Scale, NRS) of the worst painful attack and fill in migraine disability questionnaires (Headache Impact Test, HIT-623, monthly, and the MIgraine Disability Assessing Scale24, MIDAS, quarterly).

Patients will be treated with galcanezumab subcutaneous injection with the first loading dose of 240mg and then every month with 120mg as recommended, according to real life clinical indication (www.europa.ema.eu).

The above-reported variables and any adverse event (AE) are recorded at baseline and monthly at every in-office visits. Telephone/email contacts are allowed when in-office visits are not possible. All AEs are reported to Eudravigilance and classified as gastrointestinal (e.g. nausea, constipation), cutaneous (e.g. injection-site reactions: rash/erythema, pruritus, urticaria, oedema/induration), arthralgia, Raynaud phenomenon, dizziness and other (<1% of patients: i.e. somnolence, alopecia, anxiety).

Patients will provide written informed consent.

Conditions
Migraine
Being tested
Galcanezumab
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Galcanezumab according to clinical indication in real life

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. e change in monthly migraine days (MMDs) on galcanezumab therapy compared to baseline

    MMDs defined as monthly migraine days collected by headache diary

    Measured: baseline, monthly and through therapy cycle completion which is an average of 1 year. and after three months after therapy withdrawal.

Secondary outcomes (1)

  1. variation in Numerical Rating Scale (NRS), monthly painkiller intake (MPI) during galcanezumab therapy compared to baseline

    NRS= 0-to-10 pain intensity of the worst migraine attacks perceived in the previous month, MPI= the number of painkiller taken in the previous month.

    Measured: baseline, monthly and through therapy cycle completion, which is an average of 1 year, and after three months after therapy withdrawal.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start1 Nov 2019
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04803513
Sponsor's protocol ID
GARLIT
Other IDs
IRB Number
Acronym
GARLIT
Status last verified
Mar 2021
First submitted
9 Mar 2021
Last updated
17 Mar 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: IPD will be shared upon request to any qualified investigator

Publications

  • Altamura C, Brunelli N, Marcosano M, Aurilia C, Egeo G, Lovati C, Favoni V, Perrotta A, Maestrini I, Schiano Di Cola F, d'Onofrio F, Finocchi C, Bertuzzo D, Bono F, Ranieri A, Albanese M, Messina R, Doretti A, Di Piero V, Cevoli S, Barbanti P, Vernieri F; GARLIT Study Group. Conversion from chronic to episodic migraine in patients treated with galcanezumab in real life in Italy: the 12-month observational, longitudinal, cohort multicenter GARLIT experience. J Neurol. 2022 Nov;269(11):5848-5857. doi: 10.1007/s00415-022-11226-4. Epub 2022 Jun 28.

    PubMed 35763113

  • Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Lovati C, Bertuzzo D, d'Onofrio F, Doretti A, Di Fiore P, Finocchi C, Schiano Di Cola F, Ranieri A, Colombo B, Bono F, Albanese M, Cevoli S, Barbanti P; GARLIT Study Group. Rapid response to galcanezumab and predictive factors in chronic migraine patients: A 3-month observational, longitudinal, cohort, multicenter, Italian real-life study. Eur J Neurol. 2022 Apr;29(4):1198-1208. doi: 10.1111/ene.15197. Epub 2021 Dec 6.

    PubMed 34826192

  • Vernieri F, Altamura C, Brunelli N, Costa CM, Aurilia C, Egeo G, Fofi L, Favoni V, Pierangeli G, Lovati C, Aguggia M, d'Onofrio F, Doretti A, Di Fiore P, Finocchi C, Rao R, Bono F, Ranieri A, Albanese M, Cevoli S, Barbanti P; GARLIT Study Group. Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain. 2021 May 3;22(1):35. doi: 10.1186/s10194-021-01247-1.

    PubMed 33941080

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Campus Bio-Medico University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fabrizio Vernieri, MD (003922541 ext. 1889, f.vernieri@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

e change in monthly migraine days (MMDs) on galcanezumab therapy compared to baseline (time frame: baseline, monthly and through therapy cycle completion which is an average of 1 year. and after three months after therapy withdrawal.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04803513, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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