Condition 1: Chronic migraine without aura. Condition 2: Chronic migraine with aura. Chronic migraine without aura Migraine with aura
Conditions
Interventions
Intervention 1: 1st Intervention group: Dyston®, 500 IU single-use, sterile vial for reconstitution, up to 500 units administered intramuscularly in the corrugator, procerus, superior frontalis, tempo
Sponsors
Imen Vaccine Alborz
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Men and women of 18 to 65 years Diagnosis of chronic migraine (=15 headache days a month for > 6 months) Headaches must have at least two of the following characteristics: unilateral location, pulsating quality, moderate-severe pain intensity and/or aggravation by or causing avoidance of routine physical activity (e.g. Walking or climbing stairs), nausea and/or vomiting, photophobia and phonophobia Informed and written consent
Exclusion criteria
Exclusion criteria: Previous treatment with botulinum toxin for chronic migraine Previous treatment with botulinum toxin for cosmetic purposes with an interval of less than three months Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function Subjects not willing to comply with the study visits Subject is currently participating or has participated in the last 3 months in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device Confirmed allergy to botulinum toxin-A or any of the product components Patients diagnosed with major depression Patients diagnosed with any serious systemic diseases such as renal or hepatic failure, any other neurologic diseases like multiple sclerosis, epilepsy, and any other diseases that in the opinion of the investigator would put the patient at risk Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% responder rate; meaning the proportion of patients with a =50% decrease from baseline in the frequency of headache days. Timepoint: baseline (week -4), week 0, week 4, 8, and 12. Method of measurement: Headache diary. | — |
Secondary
| Measure | Time frame |
|---|---|
| 30% responder rate; meaning the proportion of patients with a =30% decrease from baseline in the frequency of headache days. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Reduction of the duration of migraine attacks. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Reduction of the intensity of the migraine attacks. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Reduction of the patient’s PHQ-9 depression score. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Improvement of the patient’s quality of life according to HIT-6. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Reduction of the patient’s disability scores according to MIDAS. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary.;Incidence of any adverse events. Timepoint: Throughout the study period. Method of measurement: Headache diary.;Reduction of acute migraine medication consumption. Timepoint: Baseline (week -4), week 0, 4, 8, and 12. Method of measurement: Headache diary. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSetayesh Sadeghi
Arta zist pharmed
Outcome results
None listed