Efficacy of OnabotulinumtoxinA in Migraine

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Population studies estimate that patients who have episodic migraine transition to chronic migraine at a rate of about 2.5% per year.

CM is a devastating disorder associated to severe disability. Patients with CM frequently overuse symptomatic medications in the attempt to control their disease, which adds up to the high costs associated to the disorder In this frame, it seems of the outmost importance to strive at preventing the transition from EM to CM.

At the moment Onabotulinum toxin A (BoNT-A) represents the only drug specifically approved for CM prophylaxis.

The aim of the present study was to evaluate the efficacy of BoNT-A in reducing the number of migraine days in a population of migraineurs with a high frequency of migraine attacks over a 12-month period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

Criteria

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 .

• 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.

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®'

Withdrawal criteria

• Severe side effects, diary completion insufficient for evaluation.