Philadelphia University + Thomas Jefferson University

Headache Trials

Below is a list of trials enrolling as of March 2017.  Please contact (215) 955-2037 to find out the latest information about any of our trials and for information related to enrolling in a trial.

A Two Part Multicenter, Placebo-Controlled, Active Comparator Controlled, Single Dose Study in Acute Episodic and Chronic Cluster Headache to Evaluate the Safety and Efficacy of SOM230 subcutaneous (s.c.)

This study is designed to help determine if SOM230 helps people with cluster. Cluster is a form of very severe headache. SOM230 is an FDA-approved medication for other disorders, but physicians believe it may be helpful for cluster.   

What kind of patients are participating in this trial? To participate in this trial, you must be between the ages of 18 and 65.  You must experience a certain frequency of cluster attacks each day during your cluster cycle.

What kind of patients are not able to participate in this trial?  You cannot participate if you have uncontrolled diabetes, gallstones that cause symptoms, significant heart disease or abnormal ECGs.  You also cannot participate if you are taking one or more medications known to cause ECG changes.  You cannot participate if you are allergic to any part of the medicine.

How many visits will I need to make? You will need to visit the Jefferson Headache Center four times.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT02619617, or call (215) 955-2037

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache

This study is designed to help determine if LY2951742 (galcanezumab) helps people with chronic cluster headache attacks.  Cluster is a form of very severe headache. In this study, a medication will be injected every month for 3 months with an option up to 15 months.

What kind of patients are participating in this trial? To participate in this trial, you must be between the ages of 18 and 65. You must experience a certain frequency of cluster attacks each day during your cluster cycle.

What kind of patients are not able to participate in this trial? You cannot participate if you have a history of medication overuse headaches, significant heart disease, uncontrolled high blood pressure or a history of seizures.  You cannot participate if you are allergic to any part of the medicine.  You also cannot participate if you’ve had BoTox® injected into your head or neck within the past four months.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center six or up to twenty times depending on how long you stay in the study.

Where can I learn more?  You can learn more at ClinicalTrials.gov: NCT02438826, or call (215) 955-2037

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Cluster Headache

This study is designed to help determine if LY2951742 (galcanezumab) helps people with episodic cluster headache attacks.  Cluster is a form of very severe headache. In this study, a medication will be injected every month for 2 treatments.

What kind of patients are participating in this trial? To participate in this trial, you must be between the ages of 18 and 65.  You must experience a certain frequency of cluster attacks each day during your cluster cycle.

What kind of patients are not able to participate in this trial? You cannot participate if you have a history of medication overuse headaches, significant heart disease, uncontrolled high blood pressure or a history of seizures.  You cannot participate if you are allergic to any part of the medicine.  You also cannot participate if you’ve had BoTox® injected into your head or neck within the past four months.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center seven times.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT02397473 or call (215) 955-2037.

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Episodic Cluster Headache

This study is designed to help determine if TV48125 (fremanezumab) helps people with episodic cluster headache attacks.  Cluster is a form of very severe headache. In this study, a medication will be injected every 4 weeks for 3 times.

What kind of patients are participating in this trial? To participate in this trial, you must be between the ages of 18-70 and in good health. You must experience a certain frequency of cluster attacks each day during your cluster cycle.

What kind of patients are not able to participate in this trial? You cannot participate if you have a history of medication overuse, significant medical or psychiatric disease, abnormal ECG, used an intervention/device during the 4 weeks prior to screening.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center five times.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT02945046 or call (215) 955-2037.

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens (Intravenous/Subcutaneous and Subcutaneous) of TEV-48125 versus Placebo for the Prevention of Chronic Cluster Headache

This study is designed to help determine if TV48125 (fremanezumab) helps people with episodic cluster headache attacks.  Cluster is a form of very severe headache. In this study, a medication will be injected every 4 weeks for 3 times.

What kind of patients are participating in this trial? To participate in this trial, you must be between the ages of 18-70 and in good health. You must experience a certain frequency of cluster attacks each day during your cluster cycle.

What kind of patients are not able to participate in this trial? You cannot participate if you have a history of medication overuse, significant medical or psychiatric disease, abnormal ECG, used an intervention/device during the 4 weeks prior to screening.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center five times.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT02964338 or call (215) 955-2037.

A Double Blind Placebo Controlled Pilot Study To Collect And Evaluate Data On The Use Of Intravenous Ibuprofen In The Treatment Of An Acute Migraine Attack

This study is designed to help determine if intravenous ibuprofen helps people with migraine. Ibuprofen is the active ingredient in Motrin® and Advil®. In this study, a medication will be given during the migraine attack.

What kind of patients are participating in this trial?  To participate in this trial, you must be between the ages of 18 and 65.  You must have a certain number of migraine attacks each month.

What kind of patients are not able to participate in this trial? You cannot participate in this trial if you are taking warfarin (Coumadin®), lithium, methotrexate and certain blood pressure medications.  You cannot participate if you are allergic to any part of the medicine.  You also cannot participate if you have anemia, asthma or gastric bleeding in the past.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center three times.  One of these visits is a two to four-hour treatment session during an acute migraine attack.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT01230411 or call (215) 955-2037.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Tolerability, and Safety Study of DFN-15 in Episodic Migraine With or Without Aura

This study is designed to help determine if DFN-15 helps people with episodic migraine.

What kind of patients are participating in this trial?  To participate in this trial, you must be between the ages of 18 and 75. You must have a certain number of migraine attacks each month.  Your migraines must be of a certain severity.

What kind of patients are not able to participate in this trial? You cannot participate if you have a history of medication overuse.  You cannot participate if you’ve had BoTox® injected into your head or neck within the past four months, or if you have taken antipsychotics within the past 30 days.  You are also unable to participate in you have epilepsy, significant heart disease, uncontrolled diabetes or high blood pressure or a history of a positive drug test.

How many visits will I need to make?  You will need to visit the Jefferson Headache Center three or four times.

Where can I learn more? You can learn more at ClinicalTrials.gov: NCT03006276 or call (215) 955-2037.