Health TrialsbyHealthPanel

EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.

ConditionMigraine Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorIRCCS San Raffaele Roma

About this trial

The object of this study is to assess the effectiveness, safety, and tolerability of eptinezumab in a real life migraine population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years;

Males and females;

Willingness to sign the informed consent;

High frequency episodic migraine, at least 8 days per month of disabling migraine in the past 3 months;

Disqualifiers

Other headaches different than migraine;

Known intolerance to eptinezumab or eccipients;

Current treatment with other mAbs;

Vascular disease or Raynaud.

Trial population

all consecutive patients aged 18-75 affected by hight frequency or chronic migraine with or without medication overuse.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Eptinezumab 100 mg or Eptinezumab 300 mg administered intravenously in 100 mL saline solution

    Drug

    migraine prophylaxis

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change from baseline in monthly migraine days (MMD) in HFEM or monthly headache days (MHD) in CM;

assessment of MMD or MHD

Time frame
over 12 weeks of treatment compared to baseline
2

Change from baseline in MMD in HFEM or MHD in CM;

assessment of MMD or MHD

Time frame
over 24 weeks of treatment compared to baseline
3

Change from baseline in MMD in HFEM or MHD in CM;

assessment of MMD or MHD

Time frame
over 48 weeks of treatment compared to baseline
4

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

assessment of occurrence of Treatment-Emergent Adverse Events

Time frame
over 12 months of treatment compared to baseline

Secondary outcomes

1

Change in monthly analgesic intake

Assessment of monthly analgesic intake

Time frame
over 12 weeks compared to baseline
2

Change in monthly analgesic intake

Assessment of monthly analgesic intake

Time frame
over 24 weeks compared to baseline
3

Change in monthly analgesic intake

Assessment of monthly analgesic intake

Time frame
over 48 weeks compared to baseline
4

Change in Numeric Rating Scale (NRS)

Assessment of NRS

Time frame
over 12 weeks compared to baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Raffaele Roma

Lead sponsor

Source ClinicalTrials.gov
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