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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764320
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : November 12, 2021
Last Update Posted : November 12, 2021
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: Migraine Prophylactic Therapy Only Other: Discontinuation of Overused Medication Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021


Arm Intervention/treatment
Active Comparator: Discontinuation
Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s)
Other: Discontinuation of Overused Medication
Immediate discontinuation of the overused medication(s) and the start of new migraine preventive therapy or adjustment of current preventive therapy

Active Comparator: Preventive Therapy Only
Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s)
Other: Migraine Prophylactic Therapy Only
Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)




Primary Outcome Measures :
  1. Frequency of Moderate to Severe Headache Days [ Time Frame: 12 weeks ]
    Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity



Information from the National Library of Medicine

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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


Locations
Show Show 29 study locations
Sponsors and Collaborators
Mayo Clinic
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Todd J Schwedt, MD Mayo Clinic
Principal Investigator: David W Dodick, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Todd J. Schwedt, Mayo Clinic:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Todd J. Schwedt, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02764320    
Other Study ID Numbers: 16-001036
PCORI ( Other Grant/Funding Number: PCS-1504-30133 )
First Posted: May 6, 2016    Key Record Dates
Results First Posted: November 12, 2021
Last Update Posted: November 12, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases