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MigrainePhase 4HER-MESNCT03828539

Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

A Phase 4 study testing Erenumab and Topiramate in people with Migraine, run by Novartis Pharmaceuticals at 79 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Erenumab and Topiramate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
777 participants
Where
79 sitesGermany
Study dates
22 Feb 2019to 29 Jul 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented history of migraine in the 12 months prior to screen
  • at least 4 days per month of migraine symptoms
  • >=80% diary compliance during the Baseline period
  • Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments

Who cannot join

  • Older than 50 years of age at migraine onset
  • Pregnant or nursing
  • History of cluster or hemiplegic headache
  • History or evidence of major psychiatric disorder
  • Score of 19 or higher on Beck Depression Inventory (BDI)

Trial locations and contacts

79 sites in 1 country.

79 sites in 1 country

Germany79 sites

  • Novartis Investigative Site

    Aachen, North Rhine-Westphalia, 52062

  • Novartis Investigative Site

    Alzenau in Unterfranken, 63755

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Honnef, 53604

  • Novartis Investigative Site

    Bad Saarow, 15526

  • Novartis Investigative Site

    Bayreuth, 95445

  • Novartis Investigative Site

    Bergen, 18528

  • Novartis Investigative Site

    Berlin, 10713

  • Novartis Investigative Site

    Berlin, 120999

  • Novartis Investigative Site

    Berlin, 12101

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 12627

  • Novartis Investigative Site

    Berlin, 13156

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 14169

  • Novartis Investigative Site

    Bielefeld, D 33647

  • Novartis Investigative Site

    Böblingen, 71032

  • Novartis Investigative Site

    Bochum, 44791

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Bonn, 53177

  • Novartis Investigative Site

    Celle, 29223

  • Novartis Investigative Site

    Chemnitz, 09117

  • Novartis Investigative Site

    Cologne, 50935

  • Novartis Investigative Site

    Dillingen, 66763

  • Novartis Investigative Site

    Erbach im Odenwald, 64711

  • Novartis Investigative Site

    Essen, 45133

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt, 60313

  • Novartis Investigative Site

    Freiburg im Breisgau, 79098

  • Novartis Investigative Site

    Gelsenkirchen, 45879

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Haar, 85540

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 20253

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159

  • Novartis Investigative Site

    Heidelberg, 69120

  • Novartis Investigative Site

    Heidenheim, 89518

  • Novartis Investigative Site

    Hoppegarten, 15366

  • Novartis Investigative Site

    Ibbenbueren, 49477

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Jülich, 52428

  • Novartis Investigative Site

    Kassel, 34121

  • Novartis Investigative Site

    Kassel

  • Novartis Investigative Site

    Kiel, 24149

  • Novartis Investigative Site

    Königstein im Taunus, 61462

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Leipzig, 04107

  • Novartis Investigative Site

    Lünen, 44534

  • Novartis Investigative Site

    Mannheim, 66163

  • Novartis Investigative Site

    Marburg Wehrda, Germany, 35041

  • Novartis Investigative Site

    Mittweida, 09648

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Neu-Ulm, 89231

  • Novartis Investigative Site

    Neuburg an der Donau, 86633

  • Novartis Investigative Site

    Osnabrück, 49074

  • Novartis Investigative Site

    Pforzheim, 75172

  • Novartis Investigative Site

    Quakenbrück, 49610

  • Novartis Investigative Site

    Regensburg, 93059

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rülzheim, 76761

  • Novartis Investigative Site

    Schwerin, 19053

  • Novartis Investigative Site

    Schwerin, 19055

  • Novartis Investigative Site

    Seesen, 38723

  • Novartis Investigative Site

    Siegen, 57076

  • Novartis Investigative Site

    Sindelfingen, 71065

  • Novartis Investigative Site

    Stadtroda, 07646

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70178

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Stuttgart, 70182

  • Novartis Investigative Site

    Trier, 54292

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89073

  • Novartis Investigative Site

    Unterhaching, 82008

  • Novartis Investigative Site

    Westerstede/Oldenburg, 26655

  • Novartis Investigative Site

    Wiesbaden, 65191

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting

This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.

Read the detailed description

All patients completing the Baseline period and fulfilling baseline eligibility criteria were invited to participate to the Double-blind, double-dummy Treatment Epoch (DBTE, 24 weeks) .

Eligible patients were randomized to one of two treatment arms. DBTE started with a titration phase for topiramate of a maximum of 6 weeks to determine the maximal tolerated dose and aimed to reach the recommended treatment dose of 100 mg according to the German SmPC. After the titration phase, maintenance phase started (18 weeks). Topiramate dose had to be maintained until the end of the DBTE. Erenumab dose at beginning of the DBTE was determined patient individually by the investigator based on the guidance provided in the SmPC and was either 70 mg or 140 mg. Dose escalation from 70 mg to 140 mg in case of insufficient response was considered at anytime during the DBTE.

Dose reduction of topiramate and erenumab was not allowed during DBTE (Week 0 to Week 24). After Week 24 or if the patient discontinued study drug, a one week double-blind taper off phase followed to ensure proper down titration for topiramate. At the end of the DBTE (24 weeks) the final assessment occurred to address the objectives.

A Follow-Up Visit 4 weeks after last study visit (or 8 weeks after last IMP injection for discontinued patients) was required as part of routine safety monitoring. The primary analysis was triggered when all patients had completed their respective last visit of the DBTE.

The End of study occurred when the last patient completed last visit (LPLV).

Conditions
Migraine
Being tested
Erenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
Keywords
Migraine, Episodic migraine, Chronic migraine, Headache, erenumab, topiramate, CAMG 334, Calcitonin Gene-related Peptide, CGRP, CGRP receptor agonist, monoclonal antibody, treatment failure
Medical subject headings
Migraine Disorders, Headache

What participants receive

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

  • ErenumabBiological

    Also called AMG334

    70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks

  • TopiramateDrug

    Also called Topamax

    Film-coated tablet taken orally:

    25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.

  • Erenumab matching placeboBiological

    Erenumab matching placebo pre-filled syringue administered every 4 weeks

  • Topiramate matching placeboDrug

    Topiramate matching placebo administered daily

Study groups in NCT03828539
Study groupRoleWhat they receive
ErenumabExperimental70 mg and 140 mg Erenumab
Receives: Biological: Erenumab; Biological: Erenumab matching placebo
TopiramateActive comparatorTopiramate in the highest tolerated dose (50 - 100 mg/day)
Receives: Drug: Topiramate; Drug: Topiramate matching placebo

What is being measured

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

  1. Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)

    The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.

    Measured: 24 Weeks

Secondary outcomes (1)

  1. Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6)

    The secondary objective of this study was to evaluate the effect of erenumab compared to topiramate on the proportion of patients with at least 50% reduction from baseline in MMDs. The Baseline period was defined as the period between Week -4 and the day prior to first dose. This was analyzed by logistic regression over the last 3 months (months 4, 5, and 6) of treatment. All the subjects' data collected regarding 50% response in MMD was used in the analysis regardless of whether subjects discontinue study treatment or not. Subjects with missing response information on this endpoint were imputed as non-response (non-responder imputation).

    Measured: Baseline, Last three months (month 4, 5, and 6)

Timeline

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

  1. First posted4 Feb 2019
  2. Study start22 Feb 2019
  3. Primary completion29 Jul 2020
  4. Study completion29 Jul 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
777 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03828539
Sponsor's protocol ID
CAMG334ADE01
Other IDs
2018-000943-15, 2018
Acronym
HER-MES
Status last verified
Oct 2021
First submitted
1 Feb 2019
Last updated
11 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Ehrlich M, Hentschke C, Sieder C, Maier-Peuschel M, Reuter U. Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study. J Headache Pain. 2022 Nov 15;23(1):141. doi: 10.1186/s10194-022-01511-y.

    PubMed 36380284

  • Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, Hours-Zesiger P, Nickisch J, Sieder C, Hentschke C, Maier-Peuschel M. Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. 2022 Feb;42(2):108-118. doi: 10.1177/03331024211053571. Epub 2021 Nov 7.

    PubMed 34743579

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Erenumab and Topiramate in people with Migraine, run by Novartis Pharmaceuticals at 79 sites in Germany.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 79 sites in Germany. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) (time frame: 24 Weeks). 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 NCT03828539, which also lists 2 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 11 Oct 2021.

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