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Corticosteroid

Mind and Body Approaches for Migraine

Phase 2

Recruiting

Led By Scott Powers, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders, 3rd Edition (beta) (ICHD-3b) criteria

PedMIDAS: PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy

Must not have

Must agree not to take non-specific acute medication, such as nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications, such as triptans, more than 6 times per month

Diagnosis of epilepsy or other neurological diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post treatment (8 weeks post randomization)

Summary

This trial is testing different treatments for migraines in children and young adults to see which work best. They will use things like fMRI and daily diary entries to track progress.

Who is the study for?

This trial is for young people with migraines, who have them 8-28 days a month and experience some disruption in daily life. They must be able to swallow pills, not take certain painkillers too often, and can't start new migraine prevention meds during the study. Participants need to fit in an MRI scanner and not have metal implants or severe claustrophobia.

What is being tested?

The trial tests how well different treatments help youth with migraines by looking at brain scans, headache diaries, pain response tests, and questionnaires before/after treatment. Treatments include cognitive therapy (CBT), biofeedback training (BART), cognitive reappraisal (CR) training, amitriptyline (a medication), or placebo over 8 weeks.

What are the potential side effects?

Amitriptyline may cause dry mouth, drowsiness, constipation or heart issues like QT interval lengthening on an ECG. CBT and BART are generally safe but could potentially lead to temporary discomfort from discussing personal issues or learning relaxation techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with migraine, following the ICHD-3b criteria.

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My daily activities are mildly to severely disrupted due to my condition.

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I have had between 8 and 28 headaches in the last 28 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I agree to limit my use of NSAIDs to less than 3 times a week and migraine medications to less than 6 times a month.

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I have been diagnosed with epilepsy or another neurological condition.

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I am currently taking opioids, antipsychotics, or similar medications.

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I cannot learn to swallow pills, even with training.

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I am a sexually active youth not using or planning to use birth control.

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I have had a non-stop headache for the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post treatment (8 weeks post randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post treatment (8 weeks post randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post treatment (8 weeks post randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in functional resonance imaging (fMRI)

Conditioned pain modulation as measured in a standard protocol using quantitative sensory testing. Employed as a predictor of headache day change in the study analytic plan

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274

18%

Weight increase

10%

Tachycardia

Psychiatric Hospitalization

Hypertension

Loss of libido

Appetite increase

Concentration impaired

Memory impaired

Rash

Restlessness

Amenorrhea

Cellulitis

Appetite decrease

Apathy

Hot flashes

Akathisia

Anorgasmia

Drug abuse

Drug-related hospitalization

Blurred vision

Drooling

Dizziness upon standing

Sleep disturbed

Medical Hospitalization

Fatigue

Hiccup

Hit by a motorcycle

Hurt when riding a bike

Mental activity decreased

Muscle twitch

Sleeplessness

Pneumonia

Nightmares

Teeth grating

Incarceration

Sensory hallucinations

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citalopram

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Cognitive Behavioral Therapy (CBT)Experimental Treatment1 Intervention

Cognitive Behavioral Therapy (CBT) is a mind and body based intervention using education on gate control theory of pain, behavioral strategies such as muscle relaxation and activity pacing, and cognitive strategies including distraction, problem solving, and using calming self-statements.

Group II: AmitriptylineActive Control1 Intervention

Amitriptyline will be administered once a day at home, to be taken by mouth. Dosage will be weight-based.

Group III: Biofeedback-Assisted Relaxation Training (BART)Active Control1 Intervention

Biofeedback-Assisted Relaxation Training (BART) is a mind and body based intervention that focuses specifically on mind and body techniques such as deep breathing, muscle relaxation, and guided imagery skills to manage pain.

Group IV: Cognitive Retraining (CR)Active Control1 Intervention

Cognitive Retraining (CR) is a mind and body based intervention that focuses on the use of tests of evidence and other cognitive strategies such as positive coping statements and pleasant activities and mindfulness to manage pain.

Group V: PlaceboPlacebo Group1 Intervention

The placebo pill will be administered once a day at home, to be taken by mouth.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy (CBT)

2008

Completed Phase 4

~3620

0 / 9Eligibility criteria met