Acute migraine attacks with headache. MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: AKIS - 25 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
Product Name: AKIS - 25 MG/ML SOLUZIONE INIETTABILE 1 SIRINGA PRERIEMPITA CON AGO
Product Code: AKIS - 25 MG/ML SOLUZION
Sponsors
IBSA INSTITUT BIOCHIMIQUE SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for this study must meet all the following criteria: 1. Male and female, with an age between 18 and 65 years 2. Subjects with migraine with or without aura, according to ICHD-3criteria since at least 1 year and with 3 months of well documented retrospective history 3. Subjects with migraine onset before 50 years of age 4. Subjects with a history of migraine attacks typically lasting between 4 and 72 hours if untreated or treated unsuccessfully and with migraine episodes separated by at least 48 hours of headache pain freedom 5. Subjects with history of 2 to 8 migraine attacks per month with moderate to severe headache 6. Subjects with no more than 15 days of headache per month 7. Subjects on prophylactic migraine medication (no more than 1 prophylactic agent) on a stable dose for at least 3 months prior to study entry. If prophylaxis has been withdrawn, this should have been at least 1 month prior to inclusion or longer for compounds with long half-lives or that accumulate 8. Any female subject of childbearing potential must use adequate methods of contraception throughout the course of the study. 9. Subjects able to understand and comply with all study procedures 10. Subjects who have signed written informed consent prior to inclusion into the study. 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 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects eligible for the study must not meet any of the following criteria: 1. Subjects with major depression, schizophrenia, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments 2. Subjects with actual acute pain syndromes 3. Subjects taking medications suspected to interfere with the IMP or known to interfere with the IMP if the pathology under treatment is unstable and if, in the Investigator’s opinion, the concurrent administration of the IMP during the study may be contraindicated 4. Subjects with presence of anaemia 5. Subjects with a history or evidence of asthma 6. Subjects with uncontrolled blood hypertension with significant cardiac impairment (i.e heart failure, severe ischemic heart disease) history or cerebrovascular diseases (i.e. ictus), history of peripheral arterial disease 7. Subjects with impaired hepatic or renal function, on the basis of out of range blood and urine analyses. 8. Subjects with a history of congenital bleeding diathesis (e.g., haemophilia) or any active clinically significant bleeding, or have any underlying platelet dysfunction including (e.g. idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction) 9. Subjects with a history of allergy or hypersensitivity to any component of aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors 10. Subjects administered with NSAIDs, triptans, ergotamine, opioids, or combination analgesics as medication for acute treatment of headache for 15 or more days per month in the previous month 11. Pregnant or nursing women 12. Subjects who have participated in an investigational drug trial in the month prior to the inclusion in the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of diclofenac sodium administered subcutaneously at three different doses (25-50-75 mg/1ml) in comparison to placebo in the treatment of an acute migraine attack with headache. ;Secondary Objective: To select the most suitable dose(s) of diclofenac sodium subcutaneous injection in order to implement successive pivotal clinical trials and to evaluate safety and tolerability of diclofenac sodium as a self- administered treatment of an acute migraine attack with headache.;Primary end point(s): Percentage of subjects pain free (pain score = zero) at 2 hours after the study drug injection.;Timepoint(s) of evaluation of this end point: End of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects with the absence of photophobia at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with the absence of phonophobia at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of nausea at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of vomit at 2 hours after the injection using a binary scale (present or absent).; Percentage of subjects with absence of nausea at 12, 24 and 48 hours after the injection.; Percentage of subjects with sustained pain freedom from 2 to 24 hours after the injection.; Percentage of subjects with sustained pain freedom from 2 to 48 hours after the injection; The incidence of relapse, defined as the return of headache of any severity within 48 hours after the injection when the subjects was pain-free at 2 hours after the injection.; Percentage of subjects requiring Rescue Medication within 48 after administration of study medication.; Percentage of subjects able to function normally, at 2 hours, defined as “no impact” of migraine on the daily activities, using a 4-point Likert-like Scale: severe (score=3), moderate (score=2), mild (score=1), none (score=0); Percentage of subjects satisfied or extremely satisfied at 2 hours after initial treatment using a 5-Point Likert-like Scale: totally satisfied (score=4), satisfied (score=3), neither satisfied nor unsatisfied (score=2), unsatisfied (score=1), totally unsatisfied (score=0); Time to pain freedom, evaluated as the speed of onset of therapeutic effect.; Subject’s Global Impression of the study treatment using a 5-Point Likert-like Scale evaluated at the end of the migraine attack: excellent (score=4) ,good (score=3), fair (score=2), poor (score=1), very poor (score=0);Timepoint(s) of evaluation of this end point: End of study.; End of study.; End of study.; End of study.; End of study.; En | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Pharmaceutical Development and Services srl
Outcome results
None listed