Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Diclofenac Potassium
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: diclofenac potassium
CAS Number: 15307-81-0
Other descriptive name: DICLOFENAC POTAS
Sponsors
Glostrup Hospital, 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-32 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: · 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 · 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 · Start of new preventive migraine treatment within the last two months · Change in dosage of ongoing preventive migraine treatment within the last two months · Current preventive 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, atogepant or rimegepant) · 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: 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. 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. - Inhibitors of the BCRP (breast cancer resistance protein) transporter (eg, rifampicin) - Drugs with narrow therapeutic margins (eg, digoxin, warfarin) · 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 breastfeeding per subject self-report or medical records · Subjec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In a real-world population of adults with migraine, we would like to investigate whether 50 mg diclifenac potassium (soluable) is non-inferior to 75 mg rimegepant 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 after having taken the study medication | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory endpoints: - Absence of the most bothersome symptom at 2 hours - Relapse - Headache intensity - Rescue medication - Global evaluation - Presence or absence of associated symptoms (nausea, photophobia, phonophobia): at the time trial treatment is administered, 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 - Adverse events;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: every 30 minutes until 2 hours after treatment; hourly until 4 hours after treatment; at 12, 24 and 48 hours after treatment; and at the time of relapse - Rescue medication: 2 hours post-dose - Global evaluation; 48 hours post-dose - Presence or absence of associated symptoms (nausea, photophobia, phonophobia): - Adverse events: any time | — |
Countries
Denmark
Contacts
Public ContactDanish Headache Center
Glostrup Hospital, Danish Headache Center
Outcome results
None listed