MigrainePhase 3COMIGNCT04114630
Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab
A Phase 3 study testing erenumab 70mg/mL in people with Migraine, run by Novartis Pharmaceuticals at 27 sites in Spain.
Trial summary
Migraine is a very common, neurological disorder, characterized by recurrent episodes of headache, potential progression to more frequent and severe attack patterns, and associated symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- erenumab 70mg/mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 27 sitesSpain
- Study dates
- 30 Oct 2019to 7 Jan 2022
- Phase
- Phase 3
- 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
Who may be able to join
- During the Screening Epoch:
- Signed informed consent must be obtained prior to participation in the study.
- Adults ≥18 years of age upon entry into screening.
- Patient diagnosed with chronic and high -frequency episodic migraine (with or without aura) for at least 1 year prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
- Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
- Patients previously treated with other monoclonal antibodies for migraine can be included if the appropriate washout period according to product half-life has been done for each monoclonal antibody.
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- During the Baseline Epoch:
- Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary.
- ≥ 80% eDiary compliance during the Baseline Epoch.
Who cannot join
- Older than 50 years of age at migraine onset.
- Unable to differentiate migraine from other headaches.
- History of cluster headache or hemiplegic migraine headache.
- Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
- Use of other investigational drugs within 5 half-lives of enrollment or inappropriate washout period in case of monoclonal antibodies, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
- Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
- History or evidence of any other unstable or clinically significant medical condition that in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- Other protocol-defined inclusion/exclusion criteria may apply at the end.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
Novartis Investigative Site
Alcorcón, Madrid, 28922
Novartis Investigative Site
Barakaldo, Basque Country, 48903
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, Catalonia, 08041
Novartis Investigative Site
Bilbao, Basque Country, 48013
Novartis Investigative Site
Cadiz, Andalusia, 11009
Novartis Investigative Site
Córdoba, Andalusia, 14011
Novartis Investigative Site
Elda, Valencia, 03600
Novartis Investigative Site
Fuenlabrada, Madrid, 28942
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Lugo, Galicia, 27003
Novartis Investigative Site
Madrid, 28003
Novartis Investigatice Site
Madrid, 28006
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Pozuelo de Alarcón, Madrid, 28223
Novartis Investigative Site
Santa Cruz de Tenerife, Canary Islands, 38010
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
Novartis Investigative Site
Seville, Andalicía, 41009
Novartis Investigative Site
Seville, Andalusia, 41013
Novartis Investigative Site
Valencia, Valencia, 46010
Novartis Investigational Site
Valencia, Valencia, 46026
Novartis Investigative Site
Valladolid, Castille and León, 47005
Novartis Investigative Site
Zaragoza, Aragon, 50009
About this study
Official title: A 12-month Prospective, Phase IIIb, Multicenter, Open-label Clinical Trial to Assess Health-related Quality of Life (HRQoL) in Patients With Chronic or High-frequency Episodic Migraine Treated With Erenumab Who Present Associated Comorbidities
Migraine is a very common, neurological disorder, characterized by recurrent episodes of headache, potential progression to more frequent and severe attack patterns, and associated symptoms. In Spain, the prevalence rates are 12-13% and in women up to 17-18% Migraine has been shown to largely impair patient's Health-Related Quality of Life (HRQoL), affecting work, household chores, social activities and family life. Recurrent headache attacks and frequently persistent fear and concern about the next attack disrupt the patient's familial, occupational and social life, and reduce his/her expectations for career and financial future. The consequences of this loss of productivity is also shared in his/her private life with their family. For this reason, not only the clinical benefit but other dimensions as HRQoL or work affectation should be added to the study of the benefits of migraine treatment.
Migraine pathophysiology pathways may be shared with other illness, such as fibromyalgia, chronic fatigue or Irritable Bowel Syndrome (IBS) . The purpose of the present clinical trial is to evaluate whether erenumab, at a target dose of 70 mg or 140 mg for a period of 12 months, impacts Health-Related Quality of Life (HRQoL) among patients withchronic migraine (CM) or High-Frequency Episodic Migraine (HFEM) who are affected with at least one comorbidity (fibromyalgia, fatigue and IBS). Data from this study, will provide additional information to help clinicians in treating patients with migraine and other illness.
- Conditions
- Migraine
- Being tested
- erenumab 70mg/mL
- Keywords
- Chronic migraine, Migraine, Transformative migraine, Neurologic disease, Unremitting pain, Progressive over time, Nausea, Vomiting, Sensitivity to light,, Sensitivity to sound, Pain localized to one side of head,, Painful headache, Pain in head, Head throbbing, Sinus headache, Pounding headache
- Medical subject headings
- Migraine Disorders, Nausea, Vomiting, Photophobia, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erenumab 70mg/mLDrug
Also called AMG334
Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors
| Study group | Role | What they receive |
|---|---|---|
| erenumab | Experimental | Solution for s.c injection. Prefilled autoinjector Receives: Drug: erenumab 70mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1)
MSQ 2.1 consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Comorbidities include fibromyalgia, chronic fatigue, and/or irritable bowel syndrome (IBS)
Measured: Baseline up to approximately 12 months
Secondary outcomes (7)
Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
Correlation between HRQoL scores in migraine questionnaire (MSQ 2.1) and HRQoL scores in each comorbidity questionnaire: fibromyalgia (Fibromyalgia Impact Questionnaire, FIQ), chronic fatigue (Short Form health survey, SF-12) and IBS (Irritable Bowel Syndrome Quality of Life, IBS-QOL) in all study visits.
Measured: Baseline, month 3, 6 and 12.
Mean change in HRQoL
Health Related Quality of Life (HRQoL) in patients with migraine and at least once of these comorbitiy (fibromyalgia, chronic fatigue and irritable bowel syndrome [IBS])
Measured: Baseline, month 6 and 12.
Patient profile: number of migraine episodes/month
This description can help to understand the baseline characteristics of patients treated with erenumab and the relation with the outcomes
Measured: Baseline
Duration and exposure of 70 and 140 mg doses of erenumab
Dosing information will be collected throughout the trial including dose modifications and missed doses to provide total exposure of drug over time.
Measured: Baseline up to approximately 1 year
Change in the mean number of migrane days per month from baseline to month 12
- Efficacy of erenumab will be assessed by migraine days.
Measured: From baseline to month 12
Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
- Efficacy of erenumab.
Measured: From baseline to month 12.
Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12.
- Efficacy of erenumab.
Measured: From baseline to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start30 Oct 2019 (estimated)
- Primary completion6 Dec 2021 (estimated)
- Study completion7 Jan 2022 (estimated)
Why it stopped: No patients were enrolled and global prioritization of pipeline and research strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114630
- Sponsor's protocol ID
- CAMG334AES01
- Other IDs
- 2019-001820-36, 2019
- Acronym
- COMIG
- Status last verified
- Sep 2019
- First submitted
- 21 Aug 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Prospective, Phase IIIb, Multicenter, Open-label Clinical Trial to Assess Health-related Quality of Life (HRQoL) in Patients With Chronic or High-frequency Episodic Migraine Treated With Erenumab Who Present Associated Comorbidities
- ClinicalTrials.gov ID
- NCT04114630
- Acronym / sponsor ID
- COMIG / CAMG334AES01
- Conditions
- Migraine
- Keywords
- Chronic migraine, Migraine, Transformative migraine, Neurologic disease, Unremitting pain, Progressive over time, Nausea, Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients were enrolled and global prioritization of pipeline and research strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 6 Dec 2021 (estimated)
- Study completion
- 7 Jan 2022 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine is a very common, neurological disorder, characterized by recurrent episodes of headache, potential progression to more frequent and severe attack patterns, and associated symptoms. In Spain, the prevalence rates are 12-13% and in women up to 17-18% Migraine has been shown to largely impair patient's Health-Related Quality of Life (HRQoL), affecting work, household chores, social activities and family life. Recurrent headache attacks and frequently persistent fear and concern about the next attack disrupt the patient's familial, occupational and social life, and reduce his/her expectations for career and financial future. The consequences of this loss of productivity is also shared in his/her private life with their family. For this reason, not only the clinical benefit but other dimensions as HRQoL or work affectation should be added to the study of the benefits of migraine treatment.
Migraine pathophysiology pathways may be shared with other illness, such as fibromyalgia, chronic fatigue or Irritable Bowel Syndrome (IBS) . The purpose of the present clinical trial is to evaluate whether erenumab, at a target dose of 70 mg or 140 mg for a period of 12 months, impacts Health-Related Quality of Life (HRQoL) among patients withchronic migraine (CM) or High-Frequency Episodic Migraine (HFEM) who are affected with at least one comorbidity (fibromyalgia, fatigue and IBS). Data from this study, will provide additional information to help clinicians in treating patients with migraine and other illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erenumab | Experimental | Drug: erenumab 70mg/mLSolution for s.c injection. Prefilled autoinjector |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Adults ≥18 years of age upon entry into screening.
- Patient diagnosed with chronic and high -frequency episodic migraine (with or without aura) for at least 1 year prior to screening according to the International Classification of Headache Disorders-3rd Edition (ICHD-3).
- Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
- Patients previously treated with other monoclonal antibodies for migraine can be included if the appropriate washout period according to product half-life has been done for each monoclonal antibody.
Key exclusion criteria (8 listed)
- Older than 50 years of age at migraine onset.
- Unable to differentiate migraine from other headaches.
- History of cluster headache or hemiplegic migraine headache.
- Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
- Use of other investigational drugs within 5 half-lives of enrollment or inappropriate washout period in case of monoclonal antibodies, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erenumab 70mg/mLAlso: AMG334Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors | Drug | erenumab |
Primary outcome
Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1)
Time frame: Baseline up to approximately 12 months
MSQ 2.1 consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);\&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Comorbidities include fibromyalgia, chronic fatigue, and/or irritable bowel syndrome (IBS)
7 secondary outcomes
Association between MSQ 2.1 and other HRQoL scores in each comorbidity (fibromyalgia, chronic fatigue, and/or IBS).
Time frame: Baseline, month 3, 6 and 12.
Mean change in HRQoL
Time frame: Baseline, month 6 and 12.
Patient profile: number of migraine episodes/month
Time frame: Baseline
Duration and exposure of 70 and 140 mg doses of erenumab
Time frame: Baseline up to approximately 1 year
Change in the mean number of migrane days per month from baseline to month 12
Time frame: From baseline to month 12
Change in the mean number of days of use of acute migraine-specific medication per month from baseline to month 12
Time frame: From baseline to month 12.
Percentage of patients who achieve at least 50% or greater reduction in the mean number of migraine days per month from baseline to month 12.
Time frame: From baseline to month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing erenumab 70mg/mL in people with Migraine, run by Novartis Pharmaceuticals at 27 sites in Spain.
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 9 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients (in the overall population and by each comorbidity) who achieve a ≥5-point increase in the MSQ-RFR, MSQ-RFP domains and a ≥8-point increase in the MSQ-EF domain of the Migraine-Specific Quality of Life Questionnaire (MSQ 2.1) (time frame: Baseline up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2020.