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Cluster HeadachePhase 2/3NCT04066023

Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches

A Phase 2/3 study testing C213 Microneedle System in people with Cluster Headache, run by Zosano Pharma Corporation at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a double-blind, placebo-controlled study. Subjects who meet the entry criteria will be randomized o receive one of three blinded treatments [C213 1.9 mg patch and placebo patch; C213 3.8 mg (1.9 mg x 2 patches), two placebo patches] on Day 1 and will have up to 48 weeks to confirm and treat a cluster headache. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cluster Headache
What is being tested?
C213 Microneedle System
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
12 sitesUnited States
Study dates
3 Oct 2019to 14 Apr 2021
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent
  • Women or men 18 to 65 years of age
  • Greater than 1-year history of episodic or chronic cluster headache with onset prior to 50 years of age. Diagnosis must comply with ICHD-3 (International Headache Society (IHS) diagnostic criteria). Diagnostic criteria must include a history of at least 5 attacks not attributed to any other disorder that include all of the following criteria:
  • Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 45-180 minutes (average, when untreated)
  • Either or both of the following:
  • At least one of the following symptoms or signs, ipsilateral to the pain:
Show all 21Show fewer
  • Conjunctival injection and/or lacrimation
  • Nasal congestion and/or rhinorrhea
  • Eyelid edema
  • Forehead and facial sweating
  • Miosis and or/ptosis
  • A sense of restlessness or agitation
  • Attacks have a frequency between one every other day and eight per day for more than half of the time when the disorder is active.
  • Not better accounted for by another International Classification of Headache Disorders (ICHD) diagnosis
  • Cluster history during the 12-month period prior to the screening visit must include:
  • At least 1 cluster period
  • Averaging 2-6 headaches per day
  • Lasting at least 7 days
  • Subject can distinguish cluster headaches from other headaches (i.e., migraine and tension-type headaches)
  • Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy during the trial, and must use one of the following or be surgically sterilized: intrauterine device, or a hormonal contraceptive
  • Able to understand the operation of the electronic diary and able to apply the demo study drug patch correctly.

Who cannot join

  • Contraindications to triptans
  • Use of any prohibited concomitant medications within 30 days of screening
  • History of hemiplegic migraine or migraine with brainstem aura
  • Participation in another investigational trial within 30 days or 5 half-lives of investigational product (whichever is longer).
  • Previous M207/C213 exposure in a clinical trial
  • Subject has other significant pain problems that might confound the study assessments in the opinion of the investigator
Show all 35Show fewer
  • Diagnosis of any malignant disease (other than adequately treated or excised non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin) within the 5 years prior to screening
  • History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to study initiation
  • Subjects who have a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  • Subjects who have a known allergy or sensitivity to adhesions
  • Subjects who have skin lesions or tattoos covering the entire potential area(s) of C213 application
  • Woman who are pregnant, breast-feeding or plan a pregnancy during this study
  • Clinically significant liver disease [Alanine Aminotransferase (ALT) > 150 U/L; Aspartate Aminotransferase (AST) > 130 U/L or bilirubin > 2x ULN]
  • Clinically significant kidney disease (eGFR < 60 ml/min / 1.73 m² or to creatinine > 1.5 x ULN)
  • Subject has clinically significant ECG findings, defined by:
  • ischemic changes (defined as > 1mm of down-sloping ST segment depression in at least two contiguous leads)
  • Q-waves in at least two contiguous leads
  • clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome)
  • clinically significant arrhythmias (e.g., current atrial fibrillation)
  • History of coronary artery disease (CAD), coronary vasospasm (including Prinzmetal's angina), aortic aneurysm, peripheral vascular disease or other ischemic diseases (e.g., ischemic bowel syndrome or Raynaud's syndrome)
  • Three or more of the following CAD risk factors:
  • Current tobacco use
  • Hypertension (systolic BP > 140 or diastolic BP > 90) or receiving anti-hypertensive medication for treatment of hypertension
  • Hyperlipidemia - LDL > 159 mg/dL and/or HDL < 40 mg/dL (or on prescribed anti-cholesterol treatment)
  • Family history of premature coronary artery disease (CAD) (< 55 years of age in male first-degree relatives or < 65 years of age in female first degree relatives)
  • Diabetes mellitus
  • History of cerebral vascular accident (CVA), transient ischemic attacks (TIA), or seizures
  • History of concurrent illness that requires hospitalization within 30 days prior to study initiation
  • Any other household member currently participating in a C213 study or relative of site staff member
  • Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible
  • Any language barrier that, in the opinion of the Investigator, would preclude communication and compliance with the study requirements
  • History or current abuse of or dependence on alcohol or drugs that would interfere with the results or adherence to study requirements
  • Any positive drug screens for phencyclidine (PCP), 3,4-methylenedioxy-methamphetamine (MDMA) (ecstasy), cocaine, and/or meth/amphetamine(s)
  • Current or planned use of hallucinogens (e.g. psilocybin) during the trial
  • Any clinically relevant abnormal findings in the physical exam, vital signs or laboratory tests that, in the opinion of the Investigator, may put the subject at risk

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Dent Neuro Institute, Buffalo

    Amherst, New York, 14226

  • Atlanta Headache Specialists

    Atlanta, Georgia, 30328

  • University of Texas Southwestern Medical Center- Neurology Clinic

    Dallas, Texas, 75390

  • Nevada Headache Institute

    Las Vegas, Nevada, 89113

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Keck Medicine of USC

    Los Angeles, California, 90033

  • Medstar Georgetown University Hospital at McLean

    McLean, Virginia, 22101

  • Stanford University

    Palo Alto, California, 94304

  • Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • KI Health Partners LLC DBA New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • New England Regional Headache Center, Inc.

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Multi-Center, Parallel-Group Comparison of the Efficacy and Safety of the C213 (Zolmitriptan Microneedle System) to Placebo for the Acute Treatment of Cluster Headaches

This is a double-blind, placebo-controlled study. Subjects who meet the entry criteria will be randomized o receive one of three blinded treatments [C213 1.9 mg patch and placebo patch; C213 3.8 mg (1.9 mg x 2 patches), two placebo patches] on Day 1 and will have up to 48 weeks to confirm and treat a cluster headache. Subjects will self-administer the patches and respond to questions in the electronic diary (eDiary) until 1-hour post treatment administration.

Read the detailed description

This is a randomized, double-blinded, placebo-controlled study. Approximately 120 subjects who meet the entry criteria will be randomized 1:1:1 to receive one of three blinded treatments [C213 1.9 mg patch and placebo patch; C213 3.8 mg (1.9 mg x 2 patches), two placebo patches].

Qualified subjects will randomize to the double-blind treatment period at Day 1 and will have up to 48 weeks to confirm and treat a cluster headache. Using the eDiary to confirm they are experiencing a cluster headache, subjects will self-administer the patches and continue to respond to questions in the eDiary until 1-hour post treatment administration.

Being tested
C213 Microneedle System, Placebo
Keywords
Episodic cluster headache, Chronic cluster headache
Medical subject headings
Cluster Headache

What participants receive

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

  • C213 Microneedle SystemDrug

    Also called Zolmitriptan Microneedle System

    The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch.

  • PlaceboDrug

    Also called ZP Placebo

    The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.

Study groups in NCT04066023
Study groupRoleWhat they receive
C213 1.9 mgExperimentalC213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
Receives: Drug: C213 Microneedle System
C213 3.8mgExperimentalC213 3.8 mg administered as two 1.9 mg patches
Receives: Drug: C213 Microneedle System
PlaceboPlacebo comparatorPlacebo microneedle system administered as two placebo patches
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Subjects Who Achieve Pain Relief

    Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.

    Measured: 15 minutes

  2. Percentage of Subjects Who Achieve Sustained Pain Relief

    Sustained pain relief requires a pain rating of mild or none at each timepoint from 15 minutes to 60 minutes without the use of acute rescue medication.

    Measured: 15 minutes to 60 minutes

Secondary outcomes (9)

  1. Percentage of Subjects That Achieve Pain Relief

    Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.

    Measured: 5 minutes

  2. Percentage of Subjects That Achieve Sustained Pain Relief

    Sustained pain relief requires a pain rating of mild or none at each timepoint within the time frame without the use of acute rescue medication.

    Measured: 5 minutes to 60 minutes

  3. Percentage of Subjects That Achieve Pain Freedom

    Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.

    Measured: 10 minutes

  4. Percentage of Subjects That Achieve Sustained Pain Freedom

    Sustained pain freedom requires a pain rating of none at each timepoint within the time frame without the use of acute rescue medication.

    Measured: 15 to 60 minutes

  5. Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject

    Whether or not subjects were able to perform their usual daily activities was assessed by subject responses (Yes or No) in the electronic diary (eDiary) to the question, "Do you feel able to perform your usual daily activities?" If a subject responded "Yes" but had used a rescue medication, the subject was considered as not being able to perform the usual daily activities.

    Measured: within 20 minutes

  6. Percentage of Subjects That Achieve Pain Relief

    Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication

    Measured: 10 minutes

  7. Percentage of Subjects That Achieve Pain Relief

    Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.

    Measured: 20 minutes

  8. Percentage of Subjects That Achieve Sustained Pain Relief

    Sustained pain relief requires a pain rating of mild or none at each timepoint within the time frame without the use of acute rescue medication.

    Measured: 10 minutes to 60 minutes

  9. Percentage of Subjects That Achieve Pain Freedom

    Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.

    Measured: 20 minutes

Timeline

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

  1. First posted22 Aug 2019
  2. Study start3 Oct 2019
  3. Primary completion14 Apr 2021
  4. Study completion14 Apr 2021

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Qualified subjects are assigned to received a single administration of one of three blinded treatment assignments (one of two dose levels or placebo)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04066023
Sponsor's protocol ID
CP-2019-001
Status last verified
May 2022
First submitted
19 Aug 2019
Last updated
14 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing C213 Microneedle System in people with Cluster Headache, run by Zosano Pharma Corporation at 12 sites 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 21 inclusion and 35 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: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects Who Achieve Pain Relief (time frame: 15 minutes). The study lists 2 primary outcomes in all. 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 NCT04066023.

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 14 Jun 2022.

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