A Phase 2/3 interventional study of C213 Microneedle System and Placebo in Cluster Headache, sponsored by Zosano Pharma Corporation. Completed at 12 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Zosano Pharma Corporation · Phase 2/3, Interventional, and Treatment
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.
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's enrollment of 42 is close to the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Zosano Pharma Corporation is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Either or both of the following:
At least one of the following symptoms or signs, ipsilateral to the pain:
Cluster history during the 12-month period prior to the screening visit must include:
Exclusion Criteria:
Subject has clinically significant findings, defined by:
Three or more of the following CAD risk factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
Drug: C213 Microneedle System
C213 3.8 mg administered as two 1.9 mg patches
Drug: C213 Microneedle System
Placebo microneedle system administered as two placebo patches
Drug: Placebo
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.
Also known as: Zolmitriptan Microneedle System
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.
Also known as: ZP Placebo
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.
Time frame: 15 minutes
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.
Time frame: 15 minutes to 60 minutes
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.
Time frame: 5 minutes
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.
Time frame: 5 minutes to 60 minutes
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.
Time frame: 10 minutes
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.
Time frame: 15 to 60 minutes
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.
Time frame: within 20 minutes
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
Time frame: 10 minutes
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.
Time frame: 20 minutes
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.
Time frame: 10 minutes to 60 minutes
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.
Time frame: 20 minutes
A total of 51 subjects were screened at 12 investigative sites. Of the 51 screened subjects, 42 were randomized to receive either C213 1.9 mg (17 subjects), C213 3.8 mg (13), or placebo (12) and had up to 48 weeks from randomization to treat a qualifying headache. 23 subjects applied the study patch and entered the Treatment Period.
| Milestone | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Started | 12 | 17 | 13 |
| Completed | 9 | 9 | 7 |
| Not completed | 3 | 8 | 6 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Sponsor decision | 3 | 6 | 2 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 |
| Withdrew: Noncompliance | 0 | 1 | 1 |
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects Who Achieve Pain Relief | 3 | 5 | 5 |
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.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects Who Achieve Sustained Pain Relief | 3 | 4 | 5 |
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Pain Relief | 0 | 2 | 1 |
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.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Sustained Pain Relief | 0 | 2 | 1 |
Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Pain Freedom | 0 | 1 | 1 |
Sustained pain freedom requires a pain rating of none at each timepoint within the time frame without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Sustained Pain Freedom | 1 | 2 | 2 |
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.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject | 2 | 5 | 4 |
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Pain Relief | 2 | 3 | 3 |
Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Pain Relief | 4 | 5 | 4 |
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.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Sustained Pain Relief | 2 | 3 | 3 |
Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.
| Participants | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Percentage of Subjects That Achieve Pain Freedom | 2 | 3 | 3 |
Collected over Treatment Emergent Adverse Events were collected for 8 days (+3 days) from patch application through the End of Study or Early Discontinuation visit, up to 48 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| C213 1.9 mg | 0/9 (0%) | 0/9 (0%) | 4/9 (44.4%) |
| C213 3.8mg | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Event | Placebo | C213 1.9 mg | C213 3.8mg |
|---|---|---|---|
| Application site erythemaGeneral disorders | 1/9 | 2/9 | 0/7 |
| Corona virus infectionInfections and infestations | 0/9 | 1/9 | 1/7 |
| Atrioventricular block first degreeCardiac disorders | 0/9 | 0/9 | 1/7 |
| SunburnInjury, poisoning and procedural complications | 1/9 | 0/9 | 0/7 |
| Application site oedemaGeneral disorders | 1/9 | 0/9 | 0/7 |
| Application site bruiseGeneral disorders | 0/9 | 1/9 | 0/7 |
| TonsillitisInfections and infestations | 0/9 | 1/9 | 0/7 |
Safety Population
| Age, Continuous(years) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Mean | 52.4 ± 11.82 | 50.3 ± 12.75 | 45.4 ± 12.76 | 50.1 ± 12.12 |
| Sex: Female, Male(Participants) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Female | 1 | 3 | 2 | 6 |
| Male | 8 | 6 | 3 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 9 | 8 | 5 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 2 | 3 |
| White | 9 | 8 | 3 | 20 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| United States | 9 | 9 | 5 | 23 |
| Weight(kilograms) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Mean | 94.9 ± 9.76 | 85.3 ± 13.36 | 82.6 ± 14.88 | 88.4 ± 12.98 |
| Height(centimeters) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Mean | 180.0 ± 8.92 | 174.3 ± 9.14 | 173.7 ± 7.53 | 176.5 ± 8.82 |
| BMI(kg/m^2) | Placebo | C213 1.9 mg | C213 3.8mg | Total |
|---|---|---|---|---|
| Mean | 29.4 ± 3.51 | 28.4 ± 4.54 | 27.2 ± 3.27 | 28.6 ± 3.79 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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Zosano Pharma Corporation