Study to evaluate the efficacy of OnabotulinumtoxinA in migraine

Phase 1

• Conditions: Migraine; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-002866-38-IT
• Lead Sponsor: IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

•Subjects fulfilling the diagnostic criteria for migraine without or with aura of the International Headache Classification with a number of migraine days ranging from 9 to 14 days/month in the previous 3 months.
•The frequency needs to be confirmed over the 28 days before the screening visit (Lipton et al., Cephalalgia 2011, The INTREPID study).
•Subjects have to be in general good health, as confirmed by medical history, baseline physical examination, baseline neurological exam and vital signs.
•Females have to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
•Age between 18-65 years old

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Previous failure of more than two adequate trials of medications from different drug classes used for migraine prophylaxis;
•Onset of migraine after age 50;
•Exclusively migraine aura without headache;
•Diagnosis of other primary or secondary headache disorders. Episodic tension-tyep headache is allowed if the patient can distinguish clearly between attack of migraine and of tension-type headache;
•Another chronic painful condition (e.g. osteoarthritis, low back pain);
•A significant medical history or medical condition of neurological, cardiovascular hepatic or renal disease;
•History of suicide attempt or suicidal ideation or of a major psychiatric disorder;
•History of drug or alcohol abuse within the past two years.
•Known hypersensitivity to botulinum toxin type A or to any of the other ingredients used to form ‘Botox®’

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified