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The MOTS (Medication Overuse Treatment Strategy) Trial (MOTS)

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ClinicalTrials.gov Identifier: NCT02764320
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2016
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Todd J. Schwedt, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Migraine Other: Treatment Strategy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Optimal Treatment Strategy for Patients Who Have Chronic Migraine With Medication Overuse
Actual Study Start Date : January 9, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Discontinuation
Immediate discontinuation of the overused medication(s) and migraine preventive therapy
Other: Treatment Strategy
Both arms will initiate or optimize preventive medications. Subjects in the Discontinuation arm will stop overused medications and use an alternative rescue medication(s) with a limited frequency. Subjects in the Preventive Therapy Only arm will initiate or optimize preventive medications without immediately discontinuing the overused medication.

Active Comparator: Preventive Therapy Only
Migraine preventive therapy without immediate discontinuation of the overused medication(s)
Other: Treatment Strategy
Both arms will initiate or optimize preventive medications. Subjects in the Discontinuation arm will stop overused medications and use an alternative rescue medication(s) with a limited frequency. Subjects in the Preventive Therapy Only arm will initiate or optimize preventive medications without immediately discontinuing the overused medication.




Primary Outcome Measures :
  1. Frequency of Moderate to Severe Headache Days [ Time Frame: 12 weeks ]
    The primary outcome measure is frequency of moderate to severe headache days (i.e. days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity) during weeks 9-12 post-randomization. If non-inferiority is demonstrated for the primary outcome, then a test of superiority will be performed for the frequency of moderate to severe headache days during the first 2 weeks post-randomization.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764320


  Show 31 Study Locations
Sponsors and Collaborators
Mayo Clinic
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Todd J Schwedt, MD Mayo Clinic
Principal Investigator: David W Dodick, MD Mayo Clinic

Responsible Party: Todd J. Schwedt, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02764320     History of Changes
Other Study ID Numbers: 16-001036
PCORI ( Other Grant/Funding Number: PCS-1504-30133 )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases