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

Launched by ZOSANO PHARMA CORPORATION · Aug 21, 2019

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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