A chart review study to assess current treatment with Onabotulinumtoxin A in chronic migraine patients in Germany

A chart review study to assess current treatment with Onabotulinumtoxin A in chronic migraine patients in Germany - BOTTOM

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00028782

Enrollment

600

Registered

2022-05-25

Start date

2022-08-08

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

G43

Interventions

Group 1: Assessing current treatment with Onabotulinumtoxin A in chronic migraine patients in Germany

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Male and female patients with a diagnosis of Chronic Migraine (CM) CM Patients with treatment initiation of OnabotulinumtoxinA therapy between Jan 2020 and July 2021 and at least one completed injections cycle Patients who were at least 18 years old

Exclusion criteria

Exclusion criteria: Patients who were concomitantly enrolled in interventional studies (enrollment in a registry is not an exclusion criteria)

Design outcomes

Primary

Measure	Time frame
To describe the effectiveness of OnabotulinumtoxinA treatment on CM in regard to headache days in real world setting of patients treated in-label - Change in number of monthly headache days from start of treatment to the end of the third treatment cycle (9 months).	—

Secondary

Measure	Time frame
To describe the effectiveness of OnabotulinumtoxinA treatment on CM in regard to other outcomes in real world setting of patients treated in-label - Change in number of monthly headache days from start of treatment to 3, 6, 12 months. - Change in number of monthly migraine days from start of treatment to 3, 6, 9, 12 months. - Change in number of used acute medications from start of treatment to 3, 6, 9, 12 months, - Change in HIT-6 from start of treatment to 3, 6, 9, 12 months, - Change in pain intensity (VAS from 0 to 10, NRS) from start of treatment to 3, 6, 9, 12 months Percentage of CM patients treated with OnabotulinumtoxinA dosed in-label (=155 U to 195 U) Used treatment regime (dose, injection location and number of treatment cycles) Patient characteristics (weight, physiques, composition of muscles, physical behaviour) and disease characteristics (high burden, specific pain points comorbidities). Clinicians’ reason for applied treatment regime. Exploratory endpoint: To describe the effectiveness of OnabotulinumtoxinA treatment on CM in regard to MIDAS, EQ-5D-3L, VR12 and VAS 0-100 in real world setting of patients treated in-label. - Change in MIDAS, EQ-5D-3L, VR12 and VAS 0-100 from start of treatment to 3, 6, 9, 12 months.	—

Measure

Time frame

To describe the effectiveness of OnabotulinumtoxinA treatment on CM in regard to other outcomes in real world setting of patients treated in-label - Change in number of monthly headache days from start of treatment to 3, 6, 12 months. - Change in number of monthly migraine days from start of treatment to 3, 6, 9, 12 months. - Change in number of used acute medications from start of treatment to 3, 6, 9, 12 months, - Change in HIT-6 from start of treatment to 3, 6, 9, 12 months, - Change in pain intensity (VAS from 0 to 10, NRS) from start of treatment to 3, 6, 9, 12 months Percentage of CM patients treated with OnabotulinumtoxinA dosed in-label (=155 U to 195 U) Used treatment regime (dose, injection location and number of treatment cycles) Patient characteristics (weight, physiques, composition of muscles, physical behaviour) and disease characteristics (high burden, specific pain points comorbidities). Clinicians’ reason for applied treatment regime. Exploratory endpoint: To describe the effectiveness of OnabotulinumtoxinA treatment on CM in regard to MIDAS, EQ-5D-3L, VR12 and VAS 0-100 in real world setting of patients treated in-label. - Change in MIDAS, EQ-5D-3L, VR12 and VAS 0-100 from start of treatment to 3, 6, 9, 12 months.

—

Countries

Germany

Contacts

Public ContactCarmina Silaidos

AbbVie Deutschland GmbH & Co. KG

carmina.silaidos@abbvie.com0611-1720-4185

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026