Influence of DiGA sinCephalea on drug therapy of theProphylaxis in patients with episodic migraine
Recruiting
- Conditions
- G43.0G43.1Migraine without aura [common migraine]Migraine with aura [classical migraine]
- Registration Number
- DRKS00032604
- Lead Sponsor
- Perfood GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Patients with confirmed migraine diagnosis (migraine ICD-10 codes
G43.0 and G43.1 (ICD-11 codes 8A80.0, 8A80A.1) or diagnosis 1.1
and 1.2 of the IHS Classification ICHD-3))
Sufficient intellectual capacity to consent and participate
Ability and willingness to provide consent
Written informed consent
Exclusion Criteria
The exclusion criteria of the study are the contraindications and exclusion criteria of the approved DiGA.
Specifically, these are the following:
Contraindication (according to ICD-10): E10.- Diabetes mellitus, type 1.
Insulin therapy, non-periodic migraine or
chronic migraine
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in drug prophylaxis from before prescription<br>of sinCephalea, after 3 and 6 months of use.
- Secondary Outcome Measures
Name Time Method Comparison of medication history<br>Comparison of doctor / hospital visits<br>Comparison of the number of migraine-related sick days<br>Comparison of patient status in relation to antibody therapy<br><br>Surveyed before sinCephalea prescription, after 3 and 6 months of use.