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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Acute Migraine
Interventions Drug: ZP-Zolmitriptan
Drug: Placebo
Enrollment 365
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Hide Arm/Group Description

Placebo (either single or double patch) single administration

Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

ZP-Zolmitriptan 1 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 1.9 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

Period Title: Overall Study
Started 91 90 92 92
Completed 91 89 92 92
Not Completed 0 1 0 0
Reason Not Completed
Lost to Follow-up             0             1             0             0
Arm/Group Title Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg Total
Hide Arm/Group Description Either single or double patch administration Single 1 mg patch administration Single 1.9 mg patch administration Double 1.9 mg patch administration Total of all reporting groups
Overall Number of Baseline Participants 77 79 83 82 321
Hide Baseline Analysis Population Description
mITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 79 participants 83 participants 82 participants 321 participants
42.7  (11.53) 41.7  (11.58) 40.1  (10.92) 41.0  (11.39) 41.3  (11.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 83 participants 82 participants 321 participants
Female
69
  89.6%
70
  88.6%
73
  88.0%
68
  82.9%
280
  87.2%
Male
8
  10.4%
9
  11.4%
10
  12.0%
14
  17.1%
41
  12.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 83 participants 82 participants 321 participants
Hispanic or Latino
11
  14.3%
13
  16.5%
14
  16.9%
15
  18.3%
53
  16.5%
Not Hispanic or Latino
66
  85.7%
66
  83.5%
69
  83.1%
67
  81.7%
268
  83.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 79 participants 83 participants 82 participants 321 participants
American Indian or Alaska Native
0
   0.0%
1
   1.3%
1
   1.2%
0
   0.0%
2
   0.6%
Asian
1
   1.3%
3
   3.8%
4
   4.8%
2
   2.4%
10
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.2%
1
   1.2%
2
   0.6%
Black or African American
15
  19.5%
16
  20.3%
20
  24.1%
10
  12.2%
61
  19.0%
White
59
  76.6%
58
  73.4%
54
  65.1%
67
  81.7%
238
  74.1%
More than one race
2
   2.6%
1
   1.3%
3
   3.6%
1
   1.2%
7
   2.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.2%
1
   0.3%
1.Primary Outcome
Title Proportion of Subjects With Pain Freedom
Hide Description 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.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all subjects who were randomized, received any amount of study drug (applied the patch(es) to treat a qualifying migraine, and had at least 1 post-treatment efficacy assessment
Arm/Group Title Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Hide Arm/Group Description:

Placebo (either single or double patch) single administration

Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

ZP-Zolmitriptan 1 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 1.9 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

Overall Number of Participants Analyzed 77 79 83 82
Measure Type: Count of Participants
Unit of Measure: Participants
11
  14.3%
24
  30.4%
23
  27.7%
34
  41.5%
2.Primary Outcome
Title Proportion of Subjects With Freedom From Most Bothersome Pre-specified Other Symptom (Nausea, Photophobia, or Phonophobia Pre-specified by Subject)
Hide Description 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.
Time Frame 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
mITT
Arm/Group Title Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Hide Arm/Group Description:

Placebo (either single or double patch) single administration

Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

ZP-Zolmitriptan 1 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 1.9 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

Overall Number of Participants Analyzed 77 79 83 82
Measure Type: Count of Participants
Unit of Measure: Participants
33
  42.9%
45
  57.0%
44
  53.0%
56
  68.3%
Time Frame 2-8 days post-study drug administration for a single migraine
Adverse Event Reporting Description The number of subjects at risk includes only subjects who treated with study drug (333). Although 365 subjects were randomized, not all subjects had a migraine (a criterion for administering study drug) between randomization and the end of the trial. 32 subjects (8 in the placebo group, 10 in ZP-Zolmitriptan 1 mg, 5 in ZP-Zolmitriptan 1.9 mg, 9 in ZP-Zolmitriptan 3.8 mg) did not treat with study drug, and that is the difference between the number of subjects randomized and the number at risk.
 
Arm/Group Title Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Hide Arm/Group Description

Placebo (either single or double patch) single administration

Placebo: Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)

ZP-Zolmitriptan 1 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 1.9 mg patch single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

ZP-Zolmitriptan 3.8 mg (1.9 mg x 2 patches) single administration

ZP-Zolmitriptan: ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system

All-Cause Mortality
Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/80 (0.00%)   0/87 (0.00%)   0/83 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/83 (0.00%)   0/80 (0.00%)   0/87 (0.00%)   0/83 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo ZP-Zolmitriptan 1 mg ZP-Zolmitriptan 1.9 mg ZP-Zolmitriptan 3.8 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/83 (18.07%)   26/80 (32.50%)   37/87 (42.53%)   43/83 (51.81%) 
Gastrointestinal disorders         
Nausea   0/83 (0.00%)  2/80 (2.50%)  1/87 (1.15%)  1/83 (1.20%) 
General disorders         
Application site erythema   12/83 (14.46%)  23/80 (28.75%)  31/87 (35.63%)  38/83 (45.78%) 
Application site bruise   3/83 (3.61%)  5/80 (6.25%)  12/87 (13.79%)  12/83 (14.46%) 
Application site pain   1/83 (1.20%)  2/80 (2.50%)  2/87 (2.30%)  8/83 (9.64%) 
Application site haemorrhage   0/83 (0.00%)  3/80 (3.75%)  5/87 (5.75%)  4/83 (4.82%) 
Application site swelling   3/83 (3.61%)  1/80 (1.25%)  3/87 (3.45%)  2/83 (2.41%) 
Application site oedema   0/83 (0.00%)  1/80 (1.25%)  3/87 (3.45%)  2/83 (2.41%) 
Musculoskeletal and connective tissue disorders         
Muscle tightness *  0/83 (0.00%)  0/80 (0.00%)  1/87 (1.15%)  2/83 (2.41%) 
Nervous system disorders         
Dizziness *  0/83 (0.00%)  1/80 (1.25%)  0/87 (0.00%)  4/83 (4.82%) 
Paraesthesia *  1/83 (1.20%)  0/80 (0.00%)  0/87 (0.00%)  2/83 (2.41%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Donald Kellerman
Organization: Zosano Pharma Corporation
Phone: (510) 745-4004
EMail: dkellerman@zosanopharma.com
Layout table for additonal information
Responsible Party: Zosano Pharma Corporation
ClinicalTrials.gov Identifier: NCT02745392     History of Changes
Other Study ID Numbers: CP-2016-001
First Submitted: April 14, 2016
First Posted: April 20, 2016
Results First Submitted: January 19, 2018
Results First Posted: February 14, 2018
Last Update Posted: March 13, 2018