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
Overview
- Phase
- Phase 2
- Intervention
- C213 Microneedle System
- Conditions
- Cluster Headache
- Sponsor
- Zosano Pharma Corporation
- Enrollment
- 42
- Locations
- 12
- Primary Endpoint
- Percentage of Subjects Who Achieve Pain Relief
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •Conjunctival injection and/or lacrimation
- •Nasal congestion and/or rhinorrhea
- •Eyelid edema
- •Forehead and facial sweating
Exclusion Criteria
- •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
- •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
Arms & Interventions
C213 1.9 mg
C213, 1.9 mg administered as one 1.9 mg patch and one placebo patch
Intervention: C213 Microneedle System
C213 3.8mg
C213 3.8 mg administered as two 1.9 mg patches
Intervention: C213 Microneedle System
Placebo
Placebo microneedle system administered as two placebo patches
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage 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.
Percentage 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 Outcomes
- Percentage of Subjects That Achieve Pain Relief(20 minutes)
- Percentage of Subjects That Achieve Sustained Pain Relief(10 minutes to 60 minutes)
- Percentage of Subjects That Achieve Pain Freedom(20 minutes)
- Percentage of Subjects That Achieve Sustained Pain Freedom(15 to 60 minutes)
- Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject(within 20 minutes)