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Cluster HeadachePhase 2NCT07714369

Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache

A Phase 2 study testing Zavegepant 20 mg in people with Cluster Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess headache response rate for minimal pain at 30 minutes following zavegepant administration and to assess additional effectiveness and treatment failure endpoints at various timepoints after zavegepant administration Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cluster Headache
What is being tested?
Zavegepant 20 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A diagnosis of episodic cluster headache according to the International Classification of Headache Disorders 3rd edition
  • A history of at least 2 prior headache bouts
  • Onset of cluster headache before age 50 years
  • Cluster headache attacks last a minimum duration of 45 minutes (if untreated)
  • Evidence of signed informed consent (ICF) as described in the protocol, indicating compliance with the requirements and restrictions listed in the ICF and this protocol

Who cannot join

  • General exclusions
  • Pregnant or breastfeeding patients.
  • Inability to follow training instructions for use of nasal device.
  • Unable to speak or read English.
  • Unable to access the internet (for the Questionnaires / Case Report Forms).
  • Females of childbearing potential, without the ability to use 2 acceptable methods of contraception to avoid pregnancy for up to 48 hours after each study drug administration, followed by 1 acceptable method for 28 days after the last administration of study treatment.
Show all 34Show fewer
  • Body mass index ≥ 35 kg/m2
  • Prisoners or subjects who are involuntarily incarcerated.
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
  • Have participated in another clinical research study with biological investigational agents (or other relevant agents) in the last 90 days.
  • Positive drug screen for drugs of abuse at the investigator's discretion (e.g., positive amphetamines may be allowed when prescribed for an approved indication such as ADHD)
  • Past medical history exclusions:
  • Co-existing disease or other characteristics that precludes appropriate diagnosis of cluster headache. Other headache and facial pain disorders are allowed as long as their attacks are distinguishable from cluster headache attacks
  • Currently uncontrolled, unstable, or recently diagnosed cardiovascular or neurovascular disease, Raynaud's disease, uncontrolled hypertension, a history of myocardial infarction , Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or Transient Ischemic Attack (TIA) in the prior 6 months
  • A known history of severe hepatic impairment, or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
  • A history of Human Immunodeficiency Virus (HIV).
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • Response of "yes" to Question 4 or 5 for suicidal ideation, or any suicidal behavioral question on the Columbia Suicide Severity Rating Scale (C-SSRS) at screening (or up to 1 year prior to the screening, as assessed in the medical history), or any indication of serious risk of suicide in the opinion of the investigator
  • Psychiatric disorders that, in the opinion of the site investigator, would interfere with adherence to study requirements. This includes participants who have confirmed but untreated psychiatric disorders, or have psychiatric disorders that, in the opinion of the site investigator, would make them unable to undergo an ECG, have laboratory testing, or administer the medication at the appropriate time. "Psychiatric disorders" refers specifically to the following Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) classes of disorders: Schizophrenia Spectrum and Other Psychotic Disorders, Bipolar and Related Disorders, Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma- and Stressor-Related disorders, Dissociative Disorders, Somatic Symptom and Related Disorders, Feeding and Eating Disorders, Disruptive, Impulse-Control and Conduct Disorders, Substance-Related and Addictive Disorders, or Neurocognitive Disorders
  • Hematologic or solid malignancy diagnosis within 5 years prior to the screening visit. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit
  • Nasal issues
  • History of nasal surgery in the 6 months preceding the screening visit
  • Nose piercings that might interfere with positioning of the study medication
  • Evidence at screening of significant nasal conditions that may affect the administration or absorption of the nasal product (e.g., severe septum deviation, nasal deformity or blockage, inflammation, perforation, mucosal erosion or ulceration, polyposis, nasal trauma) as evaluated by the Investigator or medically qualified delegate
  • Prominent nasal congestion or rhinorrhea associated with cluster headache attacks that, in the opinion of the study team, will interfere with ipsilateral absorption of a nasal spray
  • Laboratory and ECG abnormalities within 3 months of screening including:
  • ECG abnormalities including Corrected QT interval (QTc) > 470 msec, Left Bundle Branch Block (LBB), Right Bundle Branch Block (RBB) with QRS>150 msec, or Intraventricular Conduction Defect with a QRS duration ≥ 150 msec
  • History of stage 4 renal disease (creatinine clearance<30 mL/min)
  • Any unacceptable findings on laboratory studies or physical examination including bilirubin >1.5x upper limit of normal(ULN), Neutrophil count ≤ 1000/uL (or equivalent), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) >1.5x ULN
  • Uncontrolled diabetes, defined as HbA1c ≥ 7.5%
  • Zavegepant-specific exclusions
  • History of hypersensitivity reaction to zavegepant or to any of the components of zavegepant
  • Previous use of zavegepant, or previously intolerant of zavegepant (if tried for noncluster headache reasons)
  • Concomitant use of potent inhibitors/inducers of Organic Anion Transporting Polypeptide 1B3 (OATP1B3) or Sodium/Taurocholate Cotransporting Polypeptide (NTCP) transporters including atazanavir, clarithromycin, cyclosporine, estrone sulfate, lopinavir, gemfibrozil, rifampin, or ritonavir

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mark J Burish, MD, PhD contact

713-486-7771

nctt.wec@uth.tmc.edu

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Mark J Burish, MD,PhD, (713) 704-3127, nctt.wec@uth.tmc.edu

Other trials in United States

About this study

Official title: Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache: A Prospective, Open-Label, Single-Arm, Interventional Pilot Study

The purpose of this study is to assess headache response rate for minimal pain at 30 minutes following zavegepant administration and to assess additional effectiveness and treatment failure endpoints at various timepoints after zavegepant administration

Being tested
Zavegepant 20 mg
Keywords
Zavegepant, headache, CGRP
Medical subject headings
Cluster Headache, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zavegepant 20 mgDrug

    Participants will administer zavegepant 10 mg twice in quick succession (once into the left nostril, once into the right nostril, for a total of 20mg) to treat up to 3 separate cluster headache attacks maintaining a minimum interval of 48 hours between administrations.

Study groups in NCT07714369
Study groupRoleWhat they receive
ZavegepantExperimentalNot described
Receives: Drug: Zavegepant 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who achieve minimal pain at 30 minutes following their first administration of zavegepant 20mg.

    Minimal pain is defined as 0 or 1 on the 0-4 numerical rating scale.

    Measured: end of study (up to 70 days from baseline)

Secondary outcomes (5)

  1. Percentage of participants who achieve minimal pain at 15 minutes following zavegepant administration

    Minimal pain is defined as 0 or 1 on the 0-4 numerical rating scale.

    Measured: end of study (up to 70 days from baseline)

  2. Percentage of participants who achieve pain freedom at 30 minutes following zavegepant administration

    Pain freedom is defined as 0 on the 0-4 numerical rating scale.

    Measured: end of study (up to 70 days from baseline)

  3. Percentage of participants who achieve pain freedom at 15 minutes following zavegepant administration

    Pain freedom is defined as 0 on the 0-4 numerical rating scale.

    Measured: end of study (up to 70 days from baseline)

  4. Percentage of participants who use rescue therapy between 30-180 minutes following zavegepant administration

    Measured: end of study (up to 70 days from baseline)

  5. Treatment failure as assessed by the percentage of participants with cluster headache recurrence within 3 hours

    Pain recurrence is defined as both of the following: 1. A pain intensity of 0 or 1 on a 0-4 numerical rating scale at 30 minutes post-dose, and 2. pain intensity of 3 or 4 (on a 0-4 numerical rating scale) at any point between 30 minutes post-dose and 180 minutes post headache onset

    Measured: end of study (up to 70 days from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Apr 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714369
Sponsor's protocol ID
HSC-MS-26-0153
Status last verified
Sep 2026
First submitted
14 Jul 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Concern for de-identifying participants

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zavegepant 20 mg in people with Cluster Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mark J Burish, MD, PhD (713-486-7771, nctt.wec@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who achieve minimal pain at 30 minutes following their first administration of zavegepant 20mg. (time frame: end of study (up to 70 days from baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07714369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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