Trial Outcomes & Findings for The MOTS (Medication Overuse Treatment Strategy) Trial (NCT NCT02764320)

NCT ID: NCT02764320

Last Updated: 2021-11-12

Results Overview

Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity

Recruitment status

COMPLETED

Study phase

Target enrollment

720 participants

Primary outcome timeframe

12 weeks

Results posted on

2021-11-12

Participant Flow

Participant milestones

Participant milestones
Measure	Discontinuation Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Overall Study STARTED	361	359
Overall Study COMPLETED	310	310
Overall Study NOT COMPLETED	51	49

Reasons for withdrawal

Reasons for withdrawal
Measure	Discontinuation Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Overall Study Withdrawal by Subject	35	38
Overall Study Protocol Violation	11	6
Overall Study Adverse Event	2	0
Overall Study Health Issues unable to continue	2	0
Overall Study Did not meet inclusion criteria	1	0
Overall Study Subject moved	0	2
Overall Study Overused medication unavailable	0	1
Overall Study Seeking care outside site	0	1
Overall Study Technology barriers	0	1

Baseline Characteristics

The MOTS (Medication Overuse Treatment Strategy) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discontinuation n=361 Participants Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only n=359 Participants Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)	Total n=720 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 13 • n=5 Participants	44 years STANDARD_DEVIATION 13 • n=7 Participants	44 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	313 Participants n=5 Participants	317 Participants n=7 Participants	630 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	42 Participants n=7 Participants	90 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	270 Participants n=5 Participants	273 Participants n=7 Participants	543 Participants n=5 Participants
Race/Ethnicity, Customized Other	91 Participants n=5 Participants	86 Participants n=7 Participants	177 Participants n=5 Participants
Region of Enrollment United States	361 participants n=5 Participants	359 participants n=7 Participants	720 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Data not collected or analyzed on 16 subjects from the discontinuation arm. Data not collected or analyzed on 19 subjects from the preventive therapy only arm.

Number of days on which a headache lasts for at least 2 hours and at any time peaks at moderate or severe intensity

Outcome measures

Outcome measures
Measure	Discontinuation n=294 Participants Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only n=291 Participants Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Frequency of Moderate to Severe Headache Days	9.3 days Standard Deviation 7.2	9.1 days Standard Deviation 6.8

Adverse Events

Discontinuation

Serious events: 7 serious events

Other events: 20 other events

Deaths: 0 deaths

Preventive Therapy Only

Serious events: 7 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Discontinuation n=361 participants at risk Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only n=359 participants at risk Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
General disorders Fatigue	1.1% 4/361 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.56% 2/359 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Infections and infestations Sinusitis	1.1% 4/361 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Investigations Weight Gain	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	1.7% 6/359 • Number of events 6 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Nervous system disorders Headache Worsened	1.7% 6/361 • Number of events 6 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	1.4% 5/359 • Number of events 5 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Nervous system disorders Paresthesia	1.9% 7/361 • Number of events 7 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	1.1% 4/359 • Number of events 4 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.

Additional Information

Dr. Todd J. Schwedt

Mayo Clinic

Phone: 480-301-9443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Discontinuation n=361 participants at risk Migraine prophylactic therapy will be initiated or optimized with the immediate discontinuation of the overused medication(s) 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	Preventive Therapy Only n=359 participants at risk Migraine prophylactic therapy will be initiated or optimized without the early discontinuation of the overused medication(s) Migraine Prophylactic Therapy Only: Start of new migraine preventive therapy or adjustment of current preventive therapy without immediate discontinuation of the overused medication(s)
Gastrointestinal disorders Abdominal Pain	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.56% 2/359 • Number of events 2 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Blood and lymphatic system disorders Anemia	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Psychiatric disorders Anxiety	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Gastrointestinal disorders Cecal Volvulus	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Injury, poisoning and procedural complications Fall	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
General disorders Fatigue	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Nervous system disorders Headache Worsened	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Musculoskeletal and connective tissue disorders Joint Range of Motion Decrease Cervical Spine	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Cardiac disorders Left Ventricular Systolic Dysfunction	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
General disorders Non-Cardiac Chest Pain	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Musculoskeletal and connective tissue disorders Osteoporosis	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Cardiac disorders Palpitations	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Infections and infestations Sepsis	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Surgical and medical procedures Surgical Procedure - Spine	0.28% 1/361 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.00% 0/359 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Vascular disorders Thromboembolic Event	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.
Cardiac disorders Ventricular Tachycardia	0.00% 0/361 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.	0.28% 1/359 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 48 weeks on all participants.