Headache Disorders, Primary, Migraine With Aura, Migraine Without Aura, Tension-Type Headache
Conditions
Keywords
Indoprocaf, Indomethacin, Caffeine, Prochlorperazine, Migraine with Aura, Migraine without Aura, Tension-Type Headache
Brief summary
Headaches are a common medical problem that physicians frequently encounter in their practice. One of key findings of The Atlas of Headache Disorders prepared by World Health Organization (WHO) is: headache disorders, including migraine and tension-type headache (TTH), are among the most prevalent disorders of mankind. The fixed combination of indomethacin, prochlorperazine and caffeine (IndoProCaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. IndoProCaf (Difmetre®) is widely used in common daily practice only in Italy from early 1970s, is available at the Commonwealth of Independent States (CIS) pharmaceutical market now. There are limited data regarding IndoProCaf usage from post-marketing settings. This will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in Ukraine and Kazakhstan.
Detailed description
The study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where IndoProCaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. No additional procedures (other than the standard of care) shall be applied to the patients.
Interventions
None listed
Sponsors
Almedis
Abbott
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary headache (migraine with or without aura and/or episodic TTH) and whose headache attacks required acute pharmacological treatment. * Were administered IndoProCaf (Difmetre®) effervescent tablets therapy according to the local product labelling. * Adults 18 years and older (male, female). * Provide Authorization to the investigator to use and/or disclose personal and/or health data.
Exclusion criteria
* Meet contraindications for treatment with IndoProCaf (Difmetre®) effervescent tablets as outlined in the latest version of local product labelling. * Patients who are required prescription by physician of IndoProCaf and nonsteroidal anti-inflammatory drug-containing products at the same time for acute headache attacks treatment. * Previous discontinuation of IndoProCaf treatment due to safety (i.e. hypersensitivity) events, lack of efficacy. * Female patients who are pregnant or are breast-feeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Significant Pain Reduction | up to 2 hours | significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest |
| Percentage of Patients Who Are Satisfied With IndoProCaf Treatment | up to 24 hours post dose | Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Significant Pain Reduction | up to 24 hours post-dose | Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest |
| Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response | up to 2 hours | significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest |
| Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse | up to 48 hours | significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest |
| Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | baseline | Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good) |
Countries
Kazakhstan, Ukraine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Headaches Adults taking IndoProCaf for acute treatment of their primary headache attacks (migraine and/or episodic tension-type headache) as per routine clinical practice | 702 |
| Total | 702 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete patient diary | 3 |
| Overall Study | Didn't take study drug | 2 |
| Overall Study | Lost to Follow-up | 43 |
| Overall Study | Moved to another city | 7 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Primary Headaches |
|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 11 |
| Region of Enrollment Kazakhstan | 270 Participants |
| Region of Enrollment Ukraine | 432 Participants |
| Sex: Female, Male Female | 542 Participants |
| Sex: Female, Male Male | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 16 / 702 |
| serious Total, serious adverse events | 3 / 702 |
Outcome results
Primary
Percentage of Patients Who Are Satisfied With IndoProCaf Treatment
Patients are asked to evaluate their satisfaction with headache pain reduction after treatment by selecting the options: =very poor, =poor, =no opinion, =good, =very good. The satisfied patients are defined as those with =good and = very good answers.
Time frame: up to 24 hours post dose
Population: Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Percentage of Patients Who Are Satisfied With IndoProCaf Treatment | 91.3 percentage of participants |
Primary
Percentage of Patients With Significant Pain Reduction
significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest
Time frame: up to 2 hours
Population: Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Percentage of Patients With Significant Pain Reduction | 90.3 percentage of participants |
Secondary
Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack
Defined as good and very good by Likert-type scale (e.g. very poor, poor, no opinion, good, very good)
Time frame: baseline
Population: Patients who took trip tans in the past (data are from Safety set which included all enrolled patients who have taken at least one dose of IndoProCaf).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 48.4 percentage of participants |
| Significant Pain Reduction at 2 Hours Post Dose | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 22.1 percentage of participants |
| Significant Pain Reduction at 4 Hour Post Dose | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 29.2 percentage of participants |
| Significant Pain Reduction at 6 Hours Post Dose | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 35.3 percentage of participants |
| Significant Pain Reduction at 24 Hours Post Dose | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 23.5 percentage of participants |
| Patients Who Took Opioid Analgesics | Percentage of Patients Who Are Satisfied With Different Medicines Previously Used for Headache Attack | 27.3 percentage of participants |
Secondary
Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response
significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest
Time frame: up to 2 hours
Population: Patients who took second IndoProCaf dose at 2 hours post-dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Percentage of Patients With Significant Pain Reduction in Case of First Dose no Response | 55.6 percentage of participants |
Secondary
Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse
significant pain reduction defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest
Time frame: up to 48 hours
Population: Patients who had headache relapse. Headache relapse was defined as a worsening of headache attack after 24 hours of the initial dosing and pain-free at 2h but no later than 48 hours of initial IndoProCaf dosing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Percentage of Patients With Significant Pain Reduction in Case of Headache Relapse | 90.0 percentage of participants |
Secondary
Time to Significant Pain Reduction
Time to significant pain reduction at 1, 2, 4, 6 and 24 hours post-dose period are summarized with number of patients in each category; significant pain reduction is defined as improvement to mild or no pain 2 hours post-dose by 4-point pain severity scale: 0 = no pain; 1 = mild headache, allowing normal activities; 2 = moderate headache, disturbing normal activities; 3 = severe headache, disabling activities, requiring bed-rest
Time frame: up to 24 hours post-dose
Population: Number of patients in full analysis set. Full analysis set included all patients who signed informed consent and complied with all the inclusion and exclusion criteria and who had at least one acceptable headache attack treated with IndoProCaf documented in the patient's diary. This population was used for the effectiveness endpoints reporting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Headaches | Time to Significant Pain Reduction | 464 participants |
| Significant Pain Reduction at 2 Hours Post Dose | Time to Significant Pain Reduction | 252 participants |
| Significant Pain Reduction at 4 Hour Post Dose | Time to Significant Pain Reduction | 176 participants |
| Significant Pain Reduction at 6 Hours Post Dose | Time to Significant Pain Reduction | 50 participants |
| Significant Pain Reduction at 24 Hours Post Dose | Time to Significant Pain Reduction | 15 participants |