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

NCT04114630 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: CAMG334AES012019-001820-36
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 27

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.

Conditions

Migraine

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

Outcome Measures

Primary Outcomes (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)

  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)

  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).

  Baseline, month 3, 6 and 12.

• Mean change in HRQoL

  Baseline, month 6 and 12.

• Patient profile: number of migraine episodes/month

  Baseline

• Duration and exposure of 70 and 140 mg doses of erenumab

  Baseline up to approximately 1 year

• Change in the mean number of migrane days per month from baseline to month 12

  From baseline to month 12

Study Arms (1)

erenumab

EXPERIMENTAL

Solution for s.c injection. Prefilled autoinjector

Drug: erenumab 70mg/mL

Interventions

erenumab 70mg/mL DRUG

Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors

Also known as: AMG334

erenumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (27)

Novartis Investigative Site

Seville, Andalicía, 41009, Spain

Location

Novartis Investigative Site

Cadiz, Andalusia, 11009, Spain

Location

Novartis Investigative Site

Córdoba, Andalusia, 14011, Spain

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Zaragoza, Aragon, 50009, Spain

Location

Novartis Investigative Site

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Novartis Investigative Site

Barakaldo, Basque Country, 48903, Spain

Location

Novartis Investigative Site

Bilbao, Basque Country, 48013, Spain

Location

Novartis Investigative Site

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Novartis Investigative Site

Valladolid, Castille and León, 47005, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08041, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Lugo, Galicia, 27003, Spain

Location

Novartis Investigative Site

Santiago de Compostela, Galicia, 15706, Spain

Location

Novartis Investigative Site

Alcorcón, Madrid, 28922, Spain

Location

Novartis Investigative Site

Fuenlabrada, Madrid, 28942, Spain

Location

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Elda, Valencia, 03600, Spain

Location

Novartis Investigative Site

Valencia, Valencia, 46010, Spain

Location

Novartis Investigational Site

Valencia, Valencia, 46026, Spain

Location

Novartis Investigative Site

Madrid, 28003, Spain

Location

Novartis Investigatice Site

Madrid, 28006, Spain

Location

Novartis Investigative Site

Madrid, 28040, Spain

Location

Novartis Investigative Site

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Migraine Disorders; Nausea; Vomiting; Photophobia; Headache

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Pain

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: October 3, 2019
• Study Start: October 30, 2019
• Primary Completion: December 6, 2021
• Study Completion: January 7, 2022
• Last Updated: June 1, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

ES (27)