treatment-resistant migraine. Migraine, unspecified
Conditions
Interventions
Intervention 1: Group 1: Galcanezumab (CinnaGen Co.), Galcanezumab 240 mg (2 PFSs of 120 mg/ml) at day 0 and 120 mg (one PFS) at days 30 and 60 administered by subcutaneous injection. Intervention 2:
Sponsors
Cinnagen company
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Patients are 18 to 60 years of age (inclusive) at the time of signing the informed consent form Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3 2018) (migraine with or without aura), with a history of migraine of at least 1 year prior to screening, and migraine onset prior to age 50 Prior to screening, have a history of at least 4 migraine headache days and at least 1 headache-free day per month on average within the past 3 months Prior to screening, have previous failure to 2 to 4 migraine preventive medication categories in the past 10 years from the following list: a) propranolol or metoprolol, b) topiramate, c) valproate or divalproex, d) amitriptyline or nortriptyline, e) venlafaxine or duloxetine, f) flunarizine, g) botulinum toxin A or B During prospective baseline period, have a frequency of 4 or more migraine headache days and at least 1 headache-free day in the 30-day run-in period Ability to comprehend and willingness to sign the informed consent form for this study and adherence to the study protocol principles
Exclusion criteria
Exclusion criteria: Treatment with any investigational agent in the last 30 days prior to screening visit or passing less than five half-lives of the investigational agent (whichever is longer) or participating in clinical studies consisting of any investigational agent or procedure Prior exposure to Galcanezumab or another CGRP (Calcitonin gene-related peptide) antibody Have a history of known serious allergies to any components of the formulation Receiving more than one medication or other treatments for the prevention of migraine in the run-in visit. Patients must have discontinued such treatment(s) at least 30 days prior to entering the run-in period. Botulinum toxin A and B that has been administered in the head or neck area for therapeutic use must be discontinued at least 3 months prior to entering the run-in period. Failure to respond to more than 4 migraine preventive medication categories from the list in Inclusion Criterion [4]. Previous failures to medications not on the above list will not count toward this exclusion. History of other types of headaches besides migraine, tension type headache, or medication overuse headache (MOH) as defined by IHS ICHD-3 in the 3 months prior to randomization (In other words, patients can have migraine, tension type headache, or MOH in the 3 months prior to randomization, but they cannot have other types of headaches in that time.) History of cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 History of head or neck injury within 6 months prior to screening History of traumatic head injury associated with a significant change in the quality or frequency of headaches History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, deep vein thrombosis/pulmonary embolism, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary intervention Patients who have used opioids or barbiturate >4 days per month for the treatment of pain in more than 2 of the past 3 months Alanine aminotransferase (ALT) >3-fold upper limit of normal (ULN), or total bilirubin (TBL) >2-fold ULN, or alkaline phosphatase (ALP) >3-fold ULN at the screening visit History of significant psychiatric disease, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders. Note: Patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD) whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications. Women who are pregnant, nursing, or planning a pregnancy during the study History of drug or alcohol abuse/dependence within 1 year prior to screening judged by the investigator Having any other condition such as major neurologic diseases which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall proportion of patients with =50% reduction from run-in in monthly Migraine Headache days (MHDs) during the 3-month study period. Timepoint: Beginning of study, 90 days after intervention. Method of measurement: Assessment based on electronic Patient Reported Outcome (ePRO) questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| The overall mean change from run-in in the number of monthly Migraine Headache Days (MHDs) during the 3-month study period. Timepoint: Beginning of the study, 90 days after intervention. Method of measurement: Assessment based on electronic Patient Reported Outcome (ePRO) questionnaire.;The overall mean change from run-in in the number of monthly MHDs leading to taking medication for the acute treatment of headache during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;Change from run-in in the number of monthly MHDs with: •Nausea and/or vomiting •Photophobia and/or phonophobia. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;The overall mean change from run-in in the number of monthly headache days during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;The proportion of patients who maintain 50% response criteria for all 3 months of study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;Overall mean change from run-in in the migraine attacks monthly measures (during the 3-month study period) in patients with episodic migraine. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;The overall mean change from run-in in the number of monthly moderate to severe headache days during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire.;Assessment of adverse events. Timepoint: During all scheduled visits. Method of measurement: Clinical monitoring.;Assessment of immunogenicity (Assessment of anti | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed