headacheHead Pain Studies

If you think you may qualify for one of these studies, please contact CNI’s Research Department at 303-806-7423.

 

Cluster Headaches

This headache syndrome involves what is described as “attacks” of severe pain on one side of the head lasting 15-180 minutes and occurring as little as once every day or as often as 8 times a day. Attacks are associated with eye redness, tearing from the eye, runny nose, nasal congestion, facial sweating, or sometimes eyelid swelling, all occurring on one side. Cluster headaches generally start occurring between the ages of 30-40 years of age and tend to be more common in men. Given their intermittent nature, these types of headaches can create significant anxiety due to anticipation of when the next “attack” may occur. (credit: www.coloradoheadache.com)

cGAR: A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

The aim of this study is to assess the long-term safety and tolerability of 300 mg of galcanezumab administered up to once monthly in episodic or chronic cluster headache patients who have completed study I5Q-MC-cGAL (cGAL) or study I5Q-MC-cGAM (cGAM).

eligibility and information – Enrolling by invitation
Primary Investigator: Cori Millen, DO


TEVA 30058: A Study to Explore the Long-Term Safety of TEV-48125 (Fremanezumab) for the Prevention of Cluster Headache (ENFORCE)

This study investigates the long-term safety of the study drug TEV-48125 in adult patients with cluster headaches.

eligibility and information – Enrolling by invitation
Primary Investigator: Cori Millen, DO

Downloadable Brochure: Attachment 1 Cluster Teva


Chronic Cluster Headache

TEVA 30057: A Study Comparing the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Chronic Cluster Headache (CCH)

This study investigates the effectiveness of the study drug TEV-48125 by examining the change in the monthly average number of cluster headaches.

eligibility and information – Open to enrollment
Primary Investigator: Cori Millen, DO
Research Coordinator: Angela Condellire (303.357.5443)

Downloadable Brochure: Attachment 1 Cluster Teva


cGAM: A Study of LY2951742 in Participants With Chronic Cluster Headache

The aim of this study is to assess the safety and efficacy of doses of 300 mg of Ly2951742 every 30 days for the prevention of chronic cluster headache.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


Episodic Cluster Headache

TEVA 30056: A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

This study investigates the effectiveness of the study drug TEV-48125 by examining the change in the weekly average number of cluster headaches and the number of days of use with cluster-specific acute headache medications.

eligibility and information – Open to enrollment
Primary Investigator: Cori Millen, DO
Research Coordinator: Angela Condellire (303.357.5443)

Downloadable Brochure: Attachment 1 Cluster Teva


cGAL: A Study of LY2951742 in Participants With Episodic Cluster Headache

The purpose of this study is to assess the safety and efficacy of doses of 300 mg of LY2951742 every 30 days for the prevention of episodic cluster headache.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


Migraine Headaches

This headache syndrome involves what is described as an intense pulsing or throbbing pain in one area of the head. Part of the criteria of diagnosing a migraine is by its pain and the number of attacks, as well as additional symptoms including nausea and/or vomiting or sensitivity to both light and sound. Migraine is three times more common in women than in men and affects more than 10% of people worldwide. Roughly 1/3 of affected individuals can predict the onset of a migraine because is it preceded by an “aura.” An aura can be a visual disturbance that appears as flashing lights, zig-zag lines or a temporary loss of vision. It can also include sensory or speech disturbances. (credit:  www.coloradoheadache.com)

IMPAX: Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

This study investigates the safety and effectiveness of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.

eligibility and information – Open to enrollment
Primary Investigator: Michael Pearlman, MD, PhD
Research Coordinator: Tyler Irani (720.357.0013)
 


TEVA 30051: Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine (HALO)

The primary objective of this study is to evaluate the long-term safety and tolerability of subcutaneous TEV-48125 in the preventive treatment of migraine.

eligibility and information – Enrollment by invitation
Primary Investigator: Cori Millen, DO


UBR-MD-02: Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine

The objective of this study is to evaluate the efficacy, safety and tolerability of 2 doses of the study drug (25 mg and 50 mg of ubrogepant) compared to placebo for the acute treatment of a single migraine attack.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


UBR-MD-04: An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine

The objective of this study is to evaluate the safety and tolerability of intermittent treatment with ubrogepant for the acute treatment of migraine over 1 year.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


Chronic Migraine

cGAI: Evaluation of LY2951742 in the Prevention of Chronic Migraine (REGAIN)

The purpose of this study is to assess the safety and efficacy of the study drug LY2951742 in patients with chronic migraine headache.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


TEVA 30049: Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

The aim of this study is to demonstrate the efficacy of 2 dose regimens of TEV-48125, as assessed by the decrease in the monthly average of headaches of at least moderate severity during the 12-week period after the 1st dose of study drug.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


Episodic Migraine

cGAG: Evaluation of LY2951742 in the Prevention of Episodic Migrain – the EVOLVE-1 Study

The purpose of this study is to assess the safety and efficacy of the study drug LY2951742 in patients with episodic migraine headache.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO


TEVA 30050: Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

The aim of this study is to demonstrate the efficacy of 2 dose regimens of TEV-48125, as assessed by the decrease in the monthly average number of migraine days during the 12-week period after the 1st dose of study drug.

eligibility and information – Closed to enrollment
Primary Investigator: Cori Millen, DO

Colorado Neurological Insitute