Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: BOTOX - 100 UNIT ALLERGAN POLVERE PER SOLUZIONE INIETTABILE 1 FLACONCINO
Product Name: tossina botulinica A
Product Code: M03AX01
Pharmaceutical Form: Powder for solution for injection
Sponsors
IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
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®’
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of BoNT-A in reducing the number of migraine days/month in one year;Secondary Objective: ¿ Monthly headache days; ¿ Mean migraine attack intensity; ¿ Monthly use of acute drugs; ¿ Migraine-related disability ¿ Quality of life ¿ Levels of anxiety and depression ;Primary end point(s): Efficacy will be calculated in terms of absolute and percent reduction of migraine days/month ;Timepoint(s) of evaluation of this end point: Last 16 weeks of the study period as compared to the 4 baseline weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Monthly headache days; Mean migraine attack intensity; Monthly use of acute drugs; Migraine-related disability; Quality of life; Levels of anxiety and depression;Timepoint(s) of evaluation of this end point: Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks.; Last 16 weeks of the study period as compared to the 4 baseline weeks. | — |
Countries
Italy
Contacts
Public ContactClinical Trial Center
IRCCS Fondazione Istituto Neurologico C. Mondino
Outcome results
None listed