Health TrialsbyHealthPanel

Zavegepant Intranasal Spray for the Acute Treatment of Episodic Cluster Headache

ConditionCluster Headache
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Zavegepant 20 mg

    Drug

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ZavegepantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
end of study (up to 70 days from baseline)

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
end of study (up to 70 days from baseline)
4

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

Time frame
end of study (up to 70 days from baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: