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Migraine and Headache Clinical Trial Recruitment Opportunities

A Patient’s Role in Accelerating Research Webinar Recording

Have you thought about taking part in research? Now is your chance to learn more! Watch this webinar to hear about patient experiences, types of research patients can be involved in and what studies are currently recruiting.

Migraine and Headache Clinical Trial Recruitment Opportunities

Observational Studies

Observational Study to Assess Maternal, Fetal & Infant Outcomes Following Exposure to Rimegepant 

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Inclusion Criteria: Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy. Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy

Contact: Kristin Veley, PharmD, MPH 877-366-0324, [email protected]

Click here for more information

 

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Migraine Headaches

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Inclusion Criteria: Signed informed consent and diagnosis of migraine headaches by a physician. Refer to the link for the exclusion criteria.

Contact: Sabine Hazan, MD 805-339-0549, [email protected] 

Click here for more information

 

Family Study of Affective and Anxiety Spectrum Disorders 

This study will examine how depression, anxiety, and migraine run in families. It will help in defining the risk factors for physical, mental, and health problems-as well as define ways that those problems may be prevented and treated. 

Inclusion Criteria: Must have the ability to comprehend the interview, and probands must agree to contact at least two relatives. Groups assessed will be Bipolar 1, Bipolar 2, Major Depression, Panic/Generalized Anxiety Disorder, Phobias and Migraine. 

Contact Kathleen Merikangas, Ph.D (301) 496-1172 [email protected]

Click here for more information 

 

The Will Erwin Headache Research Center – Cluster Headache Study (WEC1)

The Will Erwin Headache Research Center will assemble a national registry of Cluster Headache patients and will sub-categorize and organize this cohort based on individuating characteristics including but not limited to type and severity of condition, associated symptoms, and medical/ psychological issues. This will encompass genomic and epigenomic studies, past medical history, imaging reports, and specific physical exam results for each patient. It will also enable the study investigators to match patients with suitable interventional clinical trials. 

Inclusion Criteria: Diagnosis of a trigeminal autonomic cephalalgia according to the International Headache Classification including cluster headache, paroxysmal hemicrania, SUNCT, SUNA and hemicrania continua OR Diagnosis of a trigeminal neuralgia according to the IHC. Able to provide HIPAA authorization to share prior medical records/imaging. 

Contact: Mark J Burish, MD, PhD or Rebecca Martinez, RN [email protected]

Click here for more information

 

Natural History Surveys

SUNCT/SUNA Observational Study

Ciitizen is excited to launch a next generation, digital Observational Study to learn more about the diagnosis and treatment of short-lasting unilateral neuralgiform with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform with cranial autonomic symptoms (SUNA).

Click here for more information

 

Trigeminal Neuralgia Observational Study

Ciitizen is excited to launch a next generation, digital Observational Study to learn more about the diagnosis and treatment of Trigeminal Neuralgia (TN).

Click here for more information

 

Behavioral-Interventional Study

Acceptance & Commitment Therapy for High Frequency Migraine; A Virtual Mindfulness Intervention

Mindfulness Training specifically for pain to be offered to migraine patients. Those in the intervention group will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.

Inclusion Criteria: Women ages 18-65 with a diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria), have 4-14 migraine days per month over the past 3 months with no changes in medication in the past 3 months. Has greater than 1 year of migraines. Agreeable to participate, commit to all study procedures and to be randomized to either group. Fluent in English. Refer to the link for the exclusion criteria.

Carolyn A. Bernstein, MD Contact: 617-732-9700 or [email protected]

Click here for more information

 

Interventional Studies

Repeat Dosing of Psilocybin in Migraine Headache at Yale University

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin. In hopes of identifying an underlying mechanism in psilocybin’s effects, neuroinflammatory markers for migraine headache will be measured.

Inclusion Criteria: It is a dual gender trial of 24 patients who are 21-65 years old with a diagnosis of migraine. The person should have a typical pattern of migraine attacks with approx. 2+ migraines weekly.

Contact: Christina Forte, BA [email protected] or 203-932-5711 ext. 2526

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A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age. Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab.

Inclusion Criteria: The participant/caregiver has demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 out of 28 days, has received all recommended age-appropriate vaccines according to the local standard of care and schedule, weighs at least 17.0 kg on the day of study enrollment and has a body mass index ranging from the 5th to the 95th percentile. The participant is not using preventive medications or using no more than 1 preventive medication for migraine or other medical condition, as long as the dose and regimen have been stable for at least 2 months prior to screening.

Contact: 1-888-483-8279 or [email protected]

Click here for more information 

 

High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache

This study intends to investigate the use of high-dose Vitamin D3 plus a multivitamin in the prevention of cluster headache attacks.

Inclusion Criteria: A diagnosis of episodic cluster headache according to the ICH 3rd edition as well as cluster periods that are predictable and have a duration of 6 weeks or greater and approximately one attack daily minimum OR a diagnosis of chronic cluster headache according to the ICH 3rd edition as well as approximately one attack daily. Participants who are unlikely to need to change their preventive cluster headache treatment regimen in the next 6 weeks. 

Contact: Mark J Burish, MD, PhD or Rebecca Martinez, RN (713) 486-7771 or [email protected]

Click here for more information 

 

Feasibility of Olive Oil for Reducing Facial Pain of Trigeminal Neuralgia

This is a 16-week non-blinded, parallel, controlled trial to determine the feasibility and potential efficacy of an olive oil dietary intervention to alleviate facial pain caused by trigeminal neuralgia type 1.

Inclusion Criteria: Diagnosis of Trigeminal Neuralgia, able to provide written informed consent in English, self-identifying females 18-70 years of age, willing to consume 60 mL of olive oil and accommodating dietary changes, and thereby achieve weight maintenance. Willing to provide information about dietary intake at baseline, at the study midpoint, and at the end of the study to assess dietary changes. Willing to complete online questionnaires associated with the study. 

Contact: Wendy J Dahl, PhD 352-294-3707 or [email protected] 

Click here for more information

 

Erenumab for Idiosyncratic Facial Pain

This is a phase IV randomized, double-blinded, placebo-controlled study to evaluate the efficacy of Erenumab in subjects with midfacial pain or pressure, without clinical or radiographic evidence of sinusitis.

Inclusion Criteria: Adults 18 years of age and older presenting to Duke Head & Neck Surgery clinic for evaluation of rhinosinusitis and/or facial pain or pressure. Symptoms are present at least 10 days a month for the last 3 months as reported by subject and must include midfacial pain or uncomfortable pressure. Nasal endoscopy in the last three months shows no signs of inflammation. Sinus CT scan or MRI within 12 months of enrollment during asymptomatic period shows no more than scattered minimal mucosal edema or mucous retention cyst with patent infundibula bilaterally. For subjects with a CT scan more than 12 months old or just an MRI, a CT will be repeated for study purposes. For patients with CT scans less than 12 months old, a CT will be repeated for study purposes if the subject has changes in symptoms suggestive of sinusitis. Ability to read/write English. Has a smart phone, ipod or iPad touch for completion of the EMA on a daily basis.

Contact: Victoria Johnson 919-681-4595 [email protected] or Amy Walker 919-684-1732 [email protected]

Click here for more information

 

A 1-Year Trial To Inform About Long Term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) (CHRONICLE)

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

Inclusion Criteria: The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit. The participant has had a diagnosis of cluster headache at <50 years of age, has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit and is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).

Contact: H. Lundbeck A/S: [email protected]

Click here for more information

 

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine (PROSPECT-2)

To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.

Inclusion Criteria: The participant is 12-17 years old and has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit. During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 24 of the 28 days following the screening visit and must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Contact: H. Lundbeck A/S: [email protected]

Click here for more information

 

Emgality® Versus Nurtec® ODT Head-to-Head Migraine Preventive Treatment Study: CHALLENGE-MIG Study

The study aims to evaluate the efficacy and safety of once-monthly injectable Emgality® (galcanezumab-gnlm) compared to every-other-day Nurtec® ODT (rimegepant) taken orally. 

Inclusion criteria: Adult patients who meet the International Classification of Headache Disorders-3 (ICHD-3) criteria for a diagnosis of migraine with or without aura and experiencing 4-14 migraine headache days per month. 

Contact: ​​The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979)

Click here for more information

 

Registries

Teva Migraine Pregnancy Registry

The purpose of the Teva Migraine Pregnancy Registry is to help doctors learn more about the effects of different migraine medicines on pregnancy and babies. What is learned from this registry may help other pregnant women like yourself who suffer from migraine.

Contact: Registry Phone Number: 833-927-2605  Registry Fax Number: 800-800-1052

[email protected]syneoshealth.com

Click here for more information

 

Clusterbusters Patient Registry

Join the cluster headache registry by Clusterbusters.

Contact: [email protected]

Click here for more information

 

Antidote

If you do not fit the inclusion criteria for the trials listed above or feel overwhelmed by looking at research studies then try using Antidote. Antidote uses precision recruitment to match patients with the right trials.

To see which trials you fit best with, visit: https://www.antidote.me/clinical-trial-search 

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