Smartphone assisted migraine therapy

Phase 2

Recruiting

Conditions: G43
Migraine

Registration Number: DRKS00016328

Lead Sponsor: Charité Campus Charité Mitte

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

First presentation in the headache outpatient department of the Charité Universitätsmedizn Berlin, Universitätsmedizin Rostock or Universitätsklinik Halle
- Diagnosis of episodic migraine with at least 5 migraine days / month or chronic migraine with or without aura according to the IHCD-3 criteria
- onset of migraine before the age of 50 and lasting for at least a year
- Own an Android or iOS enabled smartphone with mobile internet access and basic understanding of apps
- Ability and readiness to give a written informed consent
- Insured with a statutory health insurance
- The M-sense calendar has been completed with a compliance rate of at least 80% in the last 28 days prior to inclusion
- The subject documented at least 5 migraine days in the baseline phase with M-sense over a period of 28 days

Exclusion Criteria

• Previous use of the M-sense active app more than 14 days
• Diagnosis of another headache disease besides migraine (all secondary headaches and primary headaches of the ICHD-3 group 3 and 4) Tension-type headaches (ICHD-3 group 2) are allowed, provided they do not account for more than 50% of headache days / month
• Previous or current drug or alcohol abuse within one year prior to visit (excessive or compulsory use as determined by the study physician)
• Current use of medication that indicates evidence of abuse or dependency (exception: analgesic or triptan overuse)
• Taking more than 3 doses / month of opioids or barbiturates

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of migraine days per 28 days in month 6 after enrollment compared to baseline (day -28 until day 0) and between patients in intervention group and control group<br>

Secondary Outcome Measures