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Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine (Zotrip)

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ClinicalTrials.gov Identifier: NCT02745392
Recruitment Status : Completed
First Posted : April 20, 2016
Results First Posted : February 14, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zosano Pharma Corporation

Tracking Information
First Submitted Date  ICMJE April 14, 2016
First Posted Date  ICMJE April 20, 2016
Results First Submitted Date  ICMJE January 19, 2018
Results First Posted Date  ICMJE February 14, 2018
Last Update Posted Date March 13, 2018
Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • Proportion of Subjects With Pain Freedom [ Time Frame: 2 hours ]
    Pain Freedom at 2 hours post study drug administration is one of the co-primary endpoints. Subjects were queried via their eDiary about their level of migraine pain (none, mild, moderate, or severe) at various intervals post-dose. Subjects who answered none at 2 hours post study drug were considered pain free at 2 hours.
  • Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject) [ Time Frame: 2 hours ]
    The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
  • Proportion of Subjects With Pain Freedom [ Time Frame: 2 hours ]
    The proportion of subjects with pain freedom at 2 hours is one of two parts of a co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.
  • Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject) [ Time Frame: 2 hours ]
    The proportion of subjects with freedom from the subject's pre-specified most bothersome symptom at 2 hours is one of two parts of the co-primary efficacy endpoint. This endpoint will be evaluated separately but both endpoints have to be met statistically for the study to be considered a success.
Change History Complete list of historical versions of study NCT02745392 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of ZP-Zolmitriptan Intracutaneous Microneedle Systems for the Acute Treatment of Migraine
Official Title  ICMJE Randomized, Double-blind, Multi-center, Parallel-group, Dose-ranging Comparison of the Safety and Efficacy of the ZP-Zolmitriptan Intracutaneous Microneedle Systems to Placebo for the Acute Treatment of Migraine
Brief Summary This is a randomized, double-blind, multi-center, parallel-group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo.
Detailed Description This is a randomized, double-blind, multi-center, parallel group study designed to compare the safety and efficacy of a range of doses of ZP-Zolmitriptan intracutaneous microneedle systems to placebo. Subjects who have consented and meet the entry criteria will be randomized to one of four blinded treatment groups. There will be a screening period of up to 1 week, followed by a run-in period to record migraine activity. The run-in period is to determine eligibility for randomization, and is planned to be 4 weeks in duration but may be extended up to an additional 4 weeks to accommodate scheduling. Qualified subjects will randomize to the double-blind treatment period at Day 0 and will have up to 8 weeks to confirm and treat a qualifying migraine. Using the eDiary to confirm they are experiencing a qualified migraine, subjects will self-administer the patch or patches and continue to respond to questions in the eDiary for 48 hours post treatment administration.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine
Intervention  ICMJE
  • Drug: ZP-Zolmitriptan
    ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
  • Drug: Placebo
    Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)
Study Arms  ICMJE
  • Experimental: ZP-Zolmitriptan 1 mg
    ZP-Zolmitriptan 1 mg patch single administration
    Intervention: Drug: ZP-Zolmitriptan
  • Experimental: ZP-Zolmitriptan 1.9 mg
    ZP-Zolmitriptan 1.9 mg patch single administration
    Intervention: Drug: ZP-Zolmitriptan
  • Experimental: ZP-Zolmitriptan 3.8 mg
    ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration
    Intervention: Drug: ZP-Zolmitriptan
  • Placebo Comparator: Placebo
    Placebo (either single or double patch) single administration
    Intervention: Drug: Placebo
Publications * Spierings EL, Brandes JL, Kudrow DB, Weintraub J, Schmidt PC, Kellerman DJ, Tepper SJ. Randomized, double-blind, placebo-controlled, parallel-group, multi-center study of the safety and efficacy of ADAM zolmitriptan for the acute treatment of migraine. Cephalalgia. 2018 Feb;38(2):215-224. doi: 10.1177/0333102417737765. Epub 2017 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2017)
365
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
360
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Greater than 1 year history of episodic, acute migraine (with or without aura) with onset prior to 50 years of age. Diagnosis must comply with International Headache Society (IHS) diagnostic criteria. Diagnostic criteria must include a history of at least five attacks not attributed to any other disorder that include all of the following criteria:

    1. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
    2. Headache has at least two of the following characteristics:

    (i) unilateral location (ii) pulsating quality (iii) moderate or severe pain intensity (iv) aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) c) During headache at least one of the following: (i) nausea and/or vomiting (ii) both photophobia and phonophobia

  • Migraine history during the 6-month period prior to the run-in period must include: 2-8 migraines per month and no more than 10 headache days per month
  • Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy during the trial, and must use an acceptable methods of birth control for the duration of the trial.
  • No significant ECG findings, defined by:

    1. ischemic changes
    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), or
    4. clinically significant arrhythmias (e.g., current atrial fibrillation)
  • Able to understand the operation of the electronic diary and is able to apply the demo study drug patch.

Exclusion Criteria:

  • Contraindication to triptans
  • Use of any prohibited concomitant medications within 10 days of the Run-in Period
  • History of hemiplegic or basilar migraine
  • Participation in another investigational trial during the 30 days prior to the Run-in Period or during this study
  • Previous participation in a clinical trial of ZP-Zolmitriptan
  • Diagnosis of cancer (other than non-invasive skin cancer) within the 5 years prior to the Run-in Period
  • History of unstable psychiatric illness requiring medication or hospitalization in the 12 months prior to the Run-in Period
  • Subjects who have known allergy or sensitivity to zolmitriptan or its derivatives or formulations
  • Subjects who have known allergy or sensitivity to adhesives
  • Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application site from two weeks prior to screening through the last day of study participation
  • Use of opiate analgesics or barbiturates more frequently than one day/week
  • Women who are pregnant, breast-feeding or plan a pregnancy during this study
  • Clinically significant liver disease
  • Clinically significant kidney disease
  • 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 or receiving anti-hypertensive medication for treatment of hypertension
    • Hyperlipidemia or on prescribed anti-cholesterol treatment
    • Family history of premature coronary artery disease (< 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, transient ischemic attacks, or seizures
  • Hospitalization within the 30 days prior to the Run-in Period
  • Any other household member currently participating in a ZP-Zolmitriptan study or relatives of site staff
  • Any reason to believe that compliance with the study requirements and completion of evaluations required for this study will not be possible
  • History or current abuse or dependence on alcohol or drugs that would interfere with adherence to study requirements
  • 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

To be eligible for Treatment, subjects must continue to meet all eligibility criteria and the following criteria observed during the Run-in Period:

  1. An average of at least two qualifying migraines per 28-day period
  2. No more than 10 headache days in the last 28 days prior to randomization
  3. Demonstrated ability to properly use the eDiary and apply the demo study drug patch
  4. Confirmation of continuing good general health, or stable non-serious disease that in the opinion of the Investigator will not place the subject at risk.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02745392
Other Study ID Numbers  ICMJE CP-2016-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zosano Pharma Corporation
Study Sponsor  ICMJE Zosano Pharma Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Donald Kellerman, Pharm.D. Zosano Pharma Corporation
PRS Account Zosano Pharma Corporation
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP