N/A
N=720
The MOTS (Medication Overuse Treatment Strategy) Trial
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02764320 ↗Enrolled (actual)
720
Serious AEs
1.9%
Results posted
Nov 2021
Primary outcome: Primary: Frequency of Moderate to Severe Headache Days — 9.3; 9.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Migraine Prophylactic Therapy Only (Other); Discontinuation of Overused Medication (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Moderate to Severe Headache Days |
9.3; 9.1 | — |
Summary
There are two commonly used treatment strategies for treating patients who have chronic migraine with medication overuse. This study will compare the outcomes amongst patients randomized to one of the two treatment strategies.
Eligibility Criteria
Inclusion Criteria
- Adults, at least 21 years of age
- Chronic Migraine - diagnosed according to ICHD3beta criteria
- Medication Overuse - diagnosed according to ICHD3beta criteria
- Willingness to be randomized to either of the two treatment arms
- Willingness to maintain a headache diary
- Plan for follow-up care with the clinician
- No changes to migraine prophylactic therapy within the 4 weeks prior to randomization.
Exclusion Criteria
- Younger than 21 years of age
- Headache diagnoses other than chronic migraine with medication overuse; episodic tension-type headache on 3 or fewer days per month is allowed
- Not willing to be randomized to either of the treatment arms
- Not willing to maintain a daily headache diary
- Not planning on follow-up care with the clinician
- In the opinion of the clinician, randomization to either treatment arm would be considered unsafe (ex: pregnancy, immediate discontinuation
- Prisoners
- Diminished decision-making capacity which in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
Data sourced from ClinicalTrials.gov (NCT02764320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.