Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Almotriptan "Sandoz"
Product Name: Almotriptan "Sandoz"
Pharmaceutical Form: Tablet
INN or Proposed INN: Almotriptan
CAS Number: 154323-57-6
Other descriptive name: ALMOTRIPTAN
Concentrati
Sponsors
Danish Headache Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has provided informed consent prior to initiation of any study-specific activities/procedures. • Aged 18 to 65 years upon entry into screening • History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the ICHD-33 criteria based on medical records and/or patient self-report. • Not more than 12 attack per month with moderate to severe headache pain in each of the previous 3 months. 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 645 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Disease Related: • Greater than 50 years of age at migraine onset • History of cluster headache or hemiplegic migraine headache • Inability to differentiate between migraine from other headaches • Has taken medication for acute treatment of headache (including acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), triptans, ergotamine, opioids, or combination analgesics) on 10 or more days per months in the previous 3 months • Has a history of migraine aura with diplopia or impairment of levels of consciousness, hemiplegic migraine, or retinal migraine. • Required hospital treatment of a migraine attack 3 or more timens in the previous 6 months. Other Medical Conditions: • The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior • Has a chronic non-headache pain condition requiring daily pain medication • Has a history of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of investigational product; participants with prior gastric bariatric interventions which have been reversed are not excluded. • Has a history of malignancy in the prior 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. • History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Medication related • Start of new preventive migraine treatment within the two months • Change in dosage of ongoing preventive migraine treatment within the last two months • Current treatment with monoclonal antibodies targeting calcitonin gene related peptide (CGRP) or CGRP receptors, or current use of small-molecule CGRP receptor antagonist (e.g. erenumab, fremanezumab, galcanezumab eller atogepant) • Changes in treatment with Selective serotonin reuptake inhibitors (SSRI) or serotonin norepinephrine reuptake inhibitors (SNRI) within the last two months • Use of the following medication within 30 days prior to screening: o Strong and moderate cytochrome P450 3A4 (CYP3A4) inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant; cyclosporine; nefazodone; cimetidine; quinine; and HIV protease inhibitors o Strong and moderate CYP3A4 inducers, including but not limited to barbiturates (eg, phenobarbital and primidone), systemic (oral/IV) glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine, phenytoin, rifampin, rifabutin, and St. John’s wort o Inhibitors of the BCRP (breast cancer resistance protein) transporter (e.g., rifampicin) o Drugs with narrow therapeutic margins (e.g., digoxin, warfarin) Other Exclusions • Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test. • Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product. • Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product. • Evidence of current pregnancy or brea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In a real-world population of adults with migraine, we would like to investigate whether 12.5 mg almotriptan is non-inferior to 50 mg ubrogepant in terms of pain freedom at 2 hours after drug intake. ;Secondary Objective: Not applicable;Primary end point(s): Pain freedom at 2 hours;Timepoint(s) of evaluation of this end point: 2 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory endpoints: - absence of the most bothersome symptom - relapse - Headache intensity - rescue medication - global evaluation - presence or absence of associated symptoms (nausea, photophobia, phonophone) ;Timepoint(s) of evaluation of this end point: Exploratory endpoints: - absence of the most bothersome symptom: 2 hours post dose - relapse: 48 hours post dose - Headache intensity: predose, 0.5, 1, 1.5, 2, 4, 12, 24 and 48 hours after initial dose - rescue medication: 48 hours post-dose - global evaluation: 48 hours post dose - presence or absence of associated symptoms (nausea, photophobia, phonophone): at the time of assessment of the primary efficacy outcome (e.g. 2 hours) and at 4, 8, 12, 24- and 48-hours post-dose | — |
Countries
Denmark
Contacts
Public ContactDanish Headache Center
Danish Headache Center
Outcome results
None listed