Influence of DiGA sinCephalea on drug therapy of the Prophylaxis in patients with episodic migraine

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032604

Enrollment

300

Registered

2023-09-04

Start date

2023-10-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G43.0 G43.1

Interventions

Group 1: Use of DiGA sinCephalea in the context of normal daily care.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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. Exclusion criteria: Insulin therapy, non-periodic migraine or chronic migraine

Design outcomes

Primary

Measure	Time frame
Change in drug prophylaxis from before prescription of sinCephalea, after 3 and 6 months of use.	—

Secondary

Measure	Time frame
Comparison of medication history Comparison of doctor / hospital visits Comparison of the number of migraine-related sick days Comparison of patient status in relation to antibody therapy Surveyed before sinCephalea prescription, after 3 and 6 months of use.	—

Countries

Germany

Contacts

Public ContactKristian Ewald

Perfood GmbH

kristian.ewald@perfood.de+4915792486332

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026