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IRCT20201104049265N3 IRCT 2022-01-30 Imen Vaccine Alborz A Prospective, Phase III Clinical Trial to Evaluate the Non-inferiority of Dyston® to Dysport® for Chronic Migraine Treatment in Adults A Randomized, Double-blind, Phase III, Parallel, Active-controlled Clinical Trial to Evaluate the Non-inferiority of the Efficacy and Safety of Dyston in Comparison with Dysport for the Treatment of Chronic Migraine in Adults 2022-01-15 anticipated 92 Complete https://irct.ir/trial/57423 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequencing of patients using random permutation blocks, blocks with the size of 4, for a total of 68 patients (1: 1 ratio) is generated online at sealedenvelope.com. The generated random sequence will be provided at the study site. According to each random code, anonymous codes are labeled on each vial (two intervention groups) and placed in the drug stock at the study site. After ensuring the patient's eligibility and obtaining informed consent, the assigned vial is injected for the patient according to the order specified in the randomization sheet, Blinding description: This study will be performed as a double-blind clinical trial. The appearance of both of the vials is made sure to be the same to maintain blinding of the physician. The patients will also be blinded to the assigned intervention. 3 Condition 1: Chronic migraine without aura. Condition 2: Chronic migraine with aura. 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, temporalis, splenius capitis, occipitalis, and the trapezius muscles. Intervention 2: 2nd Intervention group: Dysport®, 500 IU single-use, sterile vial for reconstitution, up to 500 units administered intramuscularly in the corrugator, procerus, superior frontalis, temporalis, splenius capitis, occipitalis, and the trapezius muscles. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Setayesh Sadeghi
Units 603 and 604, 6th floor, No. 18, Ryan Vanak Bldg, West corner of Sheikh Baha'i Square
Tehran Iran (Islamic Republic of) 1993873057 +98 21 8609 2794 s.sadeghi@artapharmed.com Arta zist pharmed scientific Maryam Afshani
Units 603 and 604, 6th floor, No. 18, Ryan Vanak Bldg, West corner of Sheikh Baha'i Square
Tehran Iran (Islamic Republic of) 1993873057 +98 21 8609 2794 m.afshani@artapharmed.com Arta zist pharmed Iran (Islamic Republic of) 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 18 years 65 years Both 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 G43.7 G43.1 Chronic migraine without aura Migraine with aura Treatment - Drugs Treatment - Drugs 1st Intervention group: Dyston®, 500 IU single-use, sterile vial for reconstitution, up to 500 units administered intramuscularly in the corrugator, procerus, superior frontalis, temporalis, splenius capitis, occipitalis, and the trapezius muscles 2nd Intervention group: Dysport®, 500 IU single-use, sterile vial for reconstitution, up to 500 units administered intramuscularly in the corrugator, procerus, superior frontalis, temporalis, splenius capitis, occipitalis, and the trapezius muscles 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. 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. Imen Vaccine Alborz Approved 2022-01-15 Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences Central Headquarters of the Ministry of Health, Qods Town, Tehranbetween South Flamek and Zarafshan St., Treatment and Medical Education, Sima-ye-Iran St., Tehran Tehran Iran (Islamic Republic of)