EUCTR2017-002866-38-IT
Active, not recruiting
Phase 1
Pilot study for the evaluation of the efficacy of OnabotulinumtoxinA in high frequency migraine - OnabotulinumtoxinA in migraine
IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO0 sites42 target enrollmentJune 8, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO
- Enrollment
- 42
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 (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
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®’
Outcomes
Primary Outcomes
Not specified
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