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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066023
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

Brief 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. Subjects will self-administer the patches and respond to questions in the electronic diary (eDiary) until 1-hour post treatment administration.

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: C213 Microneedle System Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All subjects, care providers, investigator, and outcomes assessors are blinded to randomized treatment assignment. Study drugs are blinded and identical in appearance.
Primary Purpose: Treatment
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
Actual Study Start Date : October 3, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: C213 1.9 mg
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
Drug: C213 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.
Other Name: Zolmitriptan Microneedle System

Experimental: C213 3.8mg
C213 3.8 mg administered as two 1.9 mg patches
Drug: C213 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.
Other Name: Zolmitriptan Microneedle System

Placebo Comparator: Placebo
Placebo microneedle system administered as two placebo patches
Drug: 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.
Other Name: ZP Placebo




Primary Outcome Measures :
  1. Proportion of subjects who achieve pain relief [ Time Frame: 15 minutes ]
    Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication.

  2. Proportion of subjects who achieve sustained pain relief [ Time Frame: 15 minutes to 60 minutes ]
    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.


Secondary Outcome Measures :
  1. Proportion of subjects that achieve pain relief [ Time Frame: 5, 10, and 20 minutes ]
    Pain relief is defined by a decrease in pain from sever to mild or none without the use of acute rescue medication.

  2. Proportion of subjects that achieve sustained pain relief [ Time Frame: 5 minutes to 60 minutes and 10 minutes to 60 minutes ]
    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.

  3. Proportion of subjects that achieve pain freedom [ Time Frame: 10 minutes and 15 minutes ]
    Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication.

  4. Proportion of subjects that achieve sustained pain freedom [ Time Frame: 10 to 60 minutes and 15 to 60 minutes ]
    Sustained pain freedom requires a pain rating of none at each timepoint within the time frame without the use of acute rescue medication.

  5. Proportion of subjects using rescue therapy [ Time Frame: within 20 minutes ]
    Listed and summarized

  6. Proportion of subjects able to perform their usual daily activities as assessed by the subject [ Time Frame: within 20 minutes ]
    Listed and summarized

  7. Incidence of adverse events and serious adverse events [ Time Frame: 1-8 days ]
    Coded by MedDRA and summarized



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Able to provide written informed consent
  2. Women or men 18 to 65 years of age
  3. 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:

    1. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 45-180 minutes (average, when untreated)
    2. Either or both of the following:

      1. At least one of the following symptoms or signs, ipsilateral to the pain:

        1. Conjunctival injection and/or lacrimation
        2. Nasal congestion and/or rhinorrhea
        3. Eyelid edema
        4. Forehead and facial sweating
        5. Miosis and or/ptosis
      2. A sense of restlessness or agitation
    3. 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.
    4. Not better accounted for by another International Classification of Headache Disorders (ICHD) diagnosis
  4. Cluster history during the 12-month period prior to the screening visit must include:

    1. At least 1 cluster period
    2. Averaging 2-6 headaches per day
    3. Lasting at least 7 days
  5. Subject can distinguish cluster headaches from other headaches (i.e., migraine and tension-type headaches)
  6. 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
  7. Able to understand the operation of the electronic diary and able to apply the demo study drug patch correctly.

Exclusion Criteria:

  1. Contraindications to triptans
  2. Use of any prohibited concomitant medications within 30 days of screening
  3. History of hemiplegic migraine or migraine with brainstem aura
  4. Participation in another investigational trial within 30 days or 5 half-lives of investigational product (whichever is longer).
  5. Previous M207/C213 exposure in a clinical trial
  6. Subject has other significant pain problems that might confound the study assessments in the opinion of the investigator
  7. 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
  8. History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to study initiation
  9. Subjects who have a known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  10. Subjects who have a known allergy or sensitivity to adhesions
  11. Subjects who have skin lesions or tattoos covering the entire potential area(s) of C213 application
  12. Woman who are pregnant, breast-feeding or plan a pregnancy during this study
  13. Clinically significant liver disease [Alanine Aminotransferase (ALT) > 150 U/L; Aspartate Aminotransferase (AST) > 130 U/L or bilirubin > 2x ULN]
  14. Clinically significant kidney disease (eGFR < 60 ml/min / 1.73 m² or to creatinine > 1.5 x ULN)
  15. Subject has clinically significant ECG findings, defined by:

    1. ischemic changes (defined as > 1mm of down-sloping ST segment depression in at least two contiguous leads)
    2. Q-waves in at least two contiguous leads
    3. clinically significant intra-ventricular conduction abnormalities (left bundle branch block or Wolf-Parkinson-White syndrome)
    4. clinically significant arrhythmias (e.g., current atrial fibrillation)
  16. 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)
  17. Three or more of the following CAD risk factors:

    1. Current tobacco use
    2. Hypertension (systolic BP > 140 or diastolic BP > 90) or receiving anti-hypertensive medication for treatment of hypertension
    3. Hyperlipidemia - LDL > 159 mg/dL and/or HDL < 40 mg/dL (or on prescribed anti-cholesterol treatment)
    4. 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)
    5. Diabetes mellitus
  18. History of cerebral vascular accident (CVA), transient ischemic attacks (TIA), or seizures
  19. History of concurrent illness that requires hospitalization within 30 days prior to study initiation
  20. Any other household member currently participating in a C213 study or relative of site staff member
  21. Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible
  22. Any language barrier that, in the opinion of the Investigator, would preclude communication and compliance with the study requirements
  23. History or current abuse of or dependence on alcohol or drugs that would interfere with the results or adherence to study requirements
  24. Any positive drug screens for phencyclidine (PCP), 3,4-methylenedioxy-methamphetamine (MDMA) (ecstasy), cocaine, and/or meth/amphetamine(s)
  25. Current or planned use of hallucinogens (e.g. psilocybin) during the trial
  26. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066023


Contacts
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Contact: Whitney Halladay (510) 745-4011 whalladay@zosanopharma.com
Contact: Peter Schmidt, MD (510) 745-1251 pschmidt@zosanopharma.com

Locations
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United States, California
Keck Medicine of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Rama Koppula       sahai@usc.edu   
Principal Investigator: Soma Sahai-Srivastava, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Stephanie Tran       trans@stanford.edu   
Principal Investigator: Nada Hindiyeh, MD         
California Medical Clinic for Headache Recruiting
Santa Monica, California, United States, 90404
Contact: Tatyana Neyman       tneyman@drkudrow.com   
Principal Investigator: David Kudrow, MD         
United States, Connecticut
KI Health Partners LLC DBA New England Institute for Clinical Research Recruiting
Stamford, Connecticut, United States, 06905
Contact: Angelo Termine       angelo@neinh.com   
Principal Investigator: Kathleen B Mullin, MD         
United States, Georgia
Atlanta Headache Specialists Recruiting
Atlanta, Georgia, United States, 30328
Contact: Wes Williams       wwilliams@pandaneuro.com   
Principal Investigator: Frank Berenson, MD         
United States, Massachusetts
New England Regional Headache Center, Inc. Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Diana Gubber-Markley       gubberdm@nerhc.org   
Principal Investigator: Herbert Markley, MD         
United States, Nevada
Nevada Headache Institute Recruiting
Las Vegas, Nevada, United States, 89113
Contact: Xavier Aradanas       xaradanas@nvhi.net   
Principal Investigator: Abraham Nagy, MDs         
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Faith Alexandre       faith.p.alexandre@hitchcock.org   
Principal Investigator: Barbara Nye, MD         
United States, New York
Dent Neuro Institute, Buffalo Recruiting
Amherst, New York, United States, 14226
Contact: Mollie Bower       mbower@dentinstitute.com   
Principal Investigator: Shivang Joshi, MD         
United States, Pennsylvania
Jefferson Headache Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Mary Hopkins       mary.hopkins@jefferson.edu   
Contact: Ashley Liautaud       ashley.liautaud@jefferson.edu   
Principal Investigator: Stephanie Nahas-Geiger, MD         
Sponsors and Collaborators
Zosano Pharma Corporation
Investigators
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Study Director: Don Kellerman, PharmD Zosano Pharma Corporation
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Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT04066023    
Other Study ID Numbers: CP-2019-001
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zosano Pharma Corporation:
Episodic cluster headache
Chronic cluster headache
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs