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Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab (COMIG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114630
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Migraine Drug: erenumab 70mg/mL Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : December 6, 2021
Estimated Study Completion Date : January 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: erenumab
Solution for s.c injection. Prefilled autoinjector
Drug: erenumab 70mg/mL
Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors
Other Name: AMG334




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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. ]
    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.

  2. Mean change in HRQoL [ Time Frame: Baseline, month 6 and 12. ]
    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])

  3. Patient profile: number of migraine episodes/month [ Time Frame: Baseline ]
    This description can help to understand the baseline characteristics of patients treated with erenumab and the relation with the outcomes

  4. Duration and exposure of 70 and 140 mg doses of erenumab [ Time Frame: Baseline up to approximately 1 year ]
    Dosing information will be collected throughout the trial including dose modifications and missed doses to provide total exposure of drug over time.

  5. Change in the mean number of migrane days per month from baseline to month 12 [ Time Frame: From baseline to month 12 ]
    • Efficacy of erenumab will be assessed by migraine days.

  6. 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. ]
    • Efficacy of erenumab.

  7. 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 ]
    • Efficacy of erenumab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: key inclusion citeria

During the Screening Epoch:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Adults ≥18 years of age upon entry into screening.
  3. 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).
  4. Patient with a documented diagnosis in clinical history of one or more of the following comorbidities: chronic fatigue, fibromyalgia and/or IBS.
  5. 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.

During the Baseline Epoch:

  1. Migraine frequency of ≥ 10 migraine days during the Baseline Epoch, confirmed by the eDiary.
  2. ≥ 80% eDiary compliance during the Baseline Epoch.

Exclusion Criteria: Key Exclusion criteria

  1. Older than 50 years of age at migraine onset.
  2. Unable to differentiate migraine from other headaches.
  3. History of cluster headache or hemiplegic migraine headache.
  4. Used a device, or procedure within 2 months prior to the start of or during baseline or during the treatment period.
  5. 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.
  6. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
  7. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114630


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Spain
Novartis Investigative Site Not yet recruiting
Sevilla, Andalicía, Spain, 41009
Novartis Investigative Site Not yet recruiting
Cadiz, Andalucia, Spain, 11009
Novartis Investigative Site Not yet recruiting
Córdoba, Andalucia, Spain, 14011
Novartis Investigative Site Not yet recruiting
Sevilla, Andalucía, Spain, 41013
Novartis Investigative Site Not yet recruiting
Zaragoza, Aragón, Spain, 50009
Novartis Investigative Site Not yet recruiting
Valladolid, Castilla León, Spain, 47005
Novartis Investigative Site Not yet recruiting
Barcelona, Cataluña, Spain, 08003
Novartis Investigative Site Not yet recruiting
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site Not yet recruiting
Barcelona, Cataluña, Spain, 08041
Novartis Investigative Site Not yet recruiting
L'Hospitalet de Llobregat, Cataluña, Spain, 08907
Novartis Investigative Site Not yet recruiting
Elda, Comunidad Valenciana, Spain, 03600
Novartis Investigative Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Novartis Investigational Site Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Novartis Investigative Site Not yet recruiting
Lugo, Galicia, Spain, 27003
Novartis Investigative Site Not yet recruiting
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site Not yet recruiting
Palma de Mallorca, Islas Baleares, Spain, 07120
Novartis Investigative Site Not yet recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38010
Novartis Investigative Site Not yet recruiting
Alcorcón, Madrid, Spain, 28922
Novartis Investigative Site Not yet recruiting
Fuenlabrada, Madrid, Spain, 28942
Novartis Investigative Site Not yet recruiting
Pozuelo de Alarcón, Madrid, Spain, 28223
Novartis Investigative Site Not yet recruiting
Pamplona, Navarra, Spain, 31008
Novartis Investigative Site Not yet recruiting
Baracaldo, País Vasco, Spain, 48903
Novartis Investigative Site Not yet recruiting
Bilbao, País Vasco, Spain, 48013
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28003
Novartis Investigatice Site Not yet recruiting
Madrid, Spain, 28006
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28040
Novartis Investigative Site Not yet recruiting
Madrid, Spain, 28046
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04114630    
Other Study ID Numbers: CAMG334AES01
2019‐001820‐36 ( EudraCT Number )
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Erenumab
Antibodies, Monoclonal
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Immunologic Factors