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29 Headache Disorders Trials

Power is an online platform that helps thousands of Headache Disorders patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.

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Galcanezumab for Migraine

Wichita, Kansas
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 17
Sex:All
300 Participants Needed
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Atogepant for Pediatric Migraine

Oklahoma City, Oklahoma
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:6 - 17
Sex:All
650 Participants Needed
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Galcanezumab for Pediatric Migraine

Overland Park, Kansas
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Prior Safety Data
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Sex:All
325 Participants Needed
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Rimegepant for Migraine

Overland Park, Kansas
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Sex:All
633 Participants Needed
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Erenumab for Pediatric Migraine

Grand Island, Nebraska
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Sex:All
456 Participants Needed
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Eptinezumab for Migraine

Springfield, Missouri
This trial is testing eptinezumab, a medication that prevents migraines, in adults who have migraines and medication overuse headaches. The goal is to see if it can reduce the number of days with migraines and headaches, and lower the use of other headache medications. The study lasts several months and includes different phases to monitor safety and effectiveness.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 75
Sex:All
609 Participants Needed
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Rimegepant for Migraine Prevention

Springfield, Missouri
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 65
Sex:All
659 Participants Needed
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Erenumab for Migraine

Frisco, Texas
This trial tests if erenumab, an injection given regularly, can reduce migraine days in children and adolescents with chronic migraines by blocking a protein that triggers these headaches. Erenumab has been shown to reduce migraine days and improve quality of life in adults with chronic and episodic migraines.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 17
Sex:All
284 Participants Needed
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Lu AG09222 for Migraine

Dallas, Texas
The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
498 Participants Needed
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Mind-Body Balance for Pediatric Migraine

Aurora, Colorado
This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 17
Sex:All
260 Participants Needed
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CBT + Amitriptyline for Childhood Migraine

Aurora, Colorado
This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 17
Sex:All
400 Participants Needed
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Mindfulness Program for Migraines

Aurora, Colorado
The goal of this study is to assess feasibility and acceptability of a mindfulness-based intervention adapted for adolescents with migraine to inform a future randomized trial assessing effects of the intervention on headache-related outcomes.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 18
Sex:All
25 Participants Needed
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Factors Influencing Migraine in Adolescents

Saint Louis, Missouri
Aim 1. To identify psychophysical and neural factors predicting migraine onset in adolescents Aim 2a. To determine hormonal, psychophysical, and neural changes associated with migraine onset. Aim 2b. To identify the temporal relationships between hormonal, psychophysical, and neural changes preceding vs. following migraine onset. Aim 3. To identify psychophysical and neural factors predicting migraine prognosis in adolescents with migraine.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 13
Sex:All
250 Participants Needed
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Intranasal Ketorolac for Migraines

Saint Louis, Missouri
The purpose of this study is to determine if intranasal (IN) Ketorolac in combination with oral Prochlorperazine and Diphenhydramine is non-inferior to current migraine management which involves use of intravenous (IV) Ketorolac and oral adjuncts Prochlorperazine and diphenhydramine for reducing pain intensity in children with migraine headaches. The investigators hypothesize that IN ketorolac combined with these oral adjuncts is non-inferior to IV ketorolac and oral adjuncts in reducing acute migraine headache pain by a minimum clinically significant difference within 60 minutes of administration.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:6 - 17
Sex:All
120 Participants Needed
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MEDI0618 for Migraine

Austin, Texas
The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
408 Participants Needed
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Brain Stimulation + Cognitive Training for Mild Traumatic Brain Injury

Minneapolis, Minnesota
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:All
160 Participants Needed
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Mixed Reality Rehabilitation for Traumatic Brain Injury

Fort Sam Houston, Texas
The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI). The main questions this comparative pilot study aims to answer are: * Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI? * Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery? Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including: * gaze stabilization * dual-task balance training * spatial navigation * agility training Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group. Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 50
Sex:All
30 Participants Needed
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Ketamine and SGB for Traumatic Brain Injury

Chicago, Illinois
Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI) with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan, as well as in more recent conflicts in Eastern Europe and the Middle East. This study aims to determine whether a procedural intervention (stellate ganglion block (SGB)) or medication (ketamine), alone or in combination, can alleviate PTSD and TBI-associated headache. Determining efficacious treatments in a randomized, double-blind, placebo-controlled, multicenter study trial may improve quality of life in those with TBI and PTSD, and identifying factors associated with treatment outcome (personalized medicine) may enhance selection, thereby improving the risk: benefit and cost-effectiveness ratios. Primary Objectives: 1. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache; 2. To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD; 3. To determine the comparative effectiveness of SGB and ketamine infusion, and the effect of combination treatment on TBI-related headache and PTSD; 4. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance; 5. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups. Secondary Objectives: 1. Exploratory Aim 1: To determine the effects of SGB, ketamine infusion, and the combination on structural and functional MRI, biomarker levels and pain thresholds and tolerance (Biomedical levels and MRI not included at Northwestern University Site). 2. Exploratory Aim 2: To identify factors associated with treatment responders overall and for individual treatment groups.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
175 Participants Needed
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Botox + Fremanezumab for Chronic Migraine

Chicago, Illinois
Chronic migraine patients treated with OnabotulinumtoxinA may experience breakthrough headaches, especially toward the end of their 12-week therapy. The addition of a CGRPmAb could help in decreasing or eliminating these episodes, but this combination is considered "experimental" by many payers, which often leads to a denial of coverage. Currently, there is no reference in the literature or data to support the treatment of chronic migraine with OnabotulinumtoxinA and CGRPmAbs (Aimovig, Ajovy, Emgality or Vyepti) combination therapy. This has resulted in many patients and providers having to settle for one or the other. Investigators hopes to provide crucial data and findings to support the addition of CGRPmAb in some chronic migraine patients currently on monotherapy OnabotulinumtoxinA.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 75
Sex:All
50 Participants Needed
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Qudexy XR for Pediatric Migraine Prevention

Birmingham, Alabama
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:6 - 11
Sex:All
132 Participants Needed
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MTX101 for Migraine

New Orleans, Louisiana
The goal of this clinical trial is to learn if drug MTX101 works to treat acute migraine attacks in adults. It will also learn about the safety of the drug MTX101. The main questions it aims to answer are: Does the drug MTX101 lower headache pain for participants and the need to use a rescue medication? What side effects, if any, do participants have when taking the drug MTX101? Researchers will compare the drug MTX101 to a placebo (a look-alike substance that contains no drug) to see if the drug MTX101 works to treat acute migraine attacks. Participants will: Take the drug MTX101 or a placebo to treat 1 migraine attack with each treatment. Visit the clinic twice and have one phone call over a 4 week period for checkups and tests. Keep a diary of their symptoms and the number of times they use a rescue medication.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
72 Participants Needed
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Mind and Body Approaches for Migraine

Cincinnati, Ohio
The overarching objective of this protocol is to identify and understand the neural and pain processing mechanisms by which youth with migraine improve in response to preventive treatment. The study design of this mechanistic investigation includes functional magnetic resonance imaging (fMRI), daily headache diaries, assessment of conditioned pain modulation via quantitative sensory testing, and validated psychometric assessments before and after the delivery of one of five treatments over an 8 week period \[cognitive behavioral therapy (CBT), biofeedback-assisted relaxation training (BART) and cognitive reappraisal (CR) training, amitriptyline, and placebo\]. We are examining both distinct and common pathways that may help explain the response to various preventive treatments, as well as potential predictors of outcome.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:10 - 17
Sex:All
132 Participants Needed
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Intravenous Fluids for Childhood Migraine

Dayton, Ohio
The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are: * Does a large amount of fluids (bolus) improve pain * Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours. Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 21
Sex:All
134 Participants Needed
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Osteopathic Treatment for TMJ Dysfunction

Auburn, Alabama
The goal of this clinical trial is to measure the effects of osteopathic manipulative treatment (OMT) on tissues of the craniocervico-mandibular unit (CCMU) in individuals with neck pain and headaches. The main questions to answer are: 1. How does OMT affect CCMU muscle stiffness 2. How does OMT affect jaw motion 3. How does OMT affect autonomic function 4. Is pain pressure threshold affected by OMT of the CCMU Participants will undergo the following interventions: 1. Photos taken to measure head and neck angles 2. Ultrasound 3. Smooth Pursuit Neck Torsion Test 4. Motion Capture 5. Autonomic Protocol 6. Algometry 7. Surveys
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:19 - 65
Sex:All
30 Participants Needed
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Behavioral Intervention for Chronic Migraine

Phoenix, Arizona
This proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. Additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. Successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
70 Participants Needed
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Ketamine for Chronic Daily Headache

Toronto, Ontario
Chronic daily headaches (CDH) poses a significant burden on patients, healthcare systems and the society. Intravenous (IV) ketamine infusion, an intervention that is widely available and scalable, can treat CDH by reversing receptor-mediated sensitization. This study is a multicenter, placebo-controlled, parallel group randomized trial with blinding of participants and observers with the goal of comprehensively assessing the effect of high-dose IV ketamine infusion (1 mg.kg-1.h-1 for six hours) on the frequency and intensity of headaches, mood, activity, sleep, quality of life and safety of ketamine for three months after the interventions. Use of validated questionnaires, wearable technology, a research team that includes investigators with expertise in studying ketamine and in evaluating treatments for CDH and pain syndromes are some of the unique features of this project. Our study aims to prospectively assess the efficacy and safety of high-dose intravenous ketamine infusions compared to saline infusions in participants with CDH syndrome.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
56 Participants Needed
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Lumbar Vein Embolization for Chronic Headaches

Jacksonville, Florida
The purpose of this research is to gather information on the safety and feasibility of coiling the lumbar vein for the treatment of chronic headaches in patients with Nutcracker physiology and retrograde lumbar vein flow with epidural venous plexus congestion. All patients are extensively evaluated by a headache trained Neurologist confirming high pressure headache refractory to other treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
4 Participants Needed
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Neuromodulation for Concussion

Buffalo, New York
Mild traumatic brain injury (mTBI) often causes persistent motor and cognitive deficits in children resulting in functional limitations. We are testing a brain stimulation method along with evaluating objective tools to help record and restore communication among affected brain areas, which will facilitate recovery in youth after mTBI.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 15
Sex:All
10 Participants Needed
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Neurofeedback Mindfulness for Migraines

Saskatoon, Saskatchewan
As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
135 Participants Needed
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Frequently Asked Questions

How much do Headache Disorders clinical trials pay?

Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.

How do Headache Disorders clinical trials work?

After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Headache Disorders trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Headache Disorders is 12 months.

How do I participate in a study as a "healthy volunteer"?

Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.

What does the "phase" of a clinical trial mean?

The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.

Do I need to be insured to participate in a Headache Disorders medical study ?

Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.

What are the newest Headache Disorders clinical trials ?

Most recently, we added MTX101 for Migraine, Ketamine and SGB for Traumatic Brain Injury and Neurofeedback Mindfulness for Migraines to the Power online platform.

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