Trial · NCT04066023
Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
NCT04066023, Phase 2, Phase 3, Completed, Zosano Pharma Corporation; results first posted 2022-05-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches. Trials, record NCT04066023. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04066023
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-Blind Comparison of the Efficacy and Safety of C213 to Placebo for the Acute Treatment of Cluster Headaches
- NCT number
- NCT04066023
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 42 participants, actual
- Lead sponsor
- Zosano Pharma Corporation
- Conditions
- Cluster Headache
- Interventions
- C213 Microneedle System, Placebo
- First posted
- 2019-08-22
- Last updated
- 2022-06-14
- Results first posted
- 2022-05-02
- Limitations and caveats
The COVID-19 pandemic had significant impact: Enrollment was hampered; therefore, Zosano ended the trial with 42 subjects randomized and 23 subjects who treated a Cluster attack. The study was thus underpowered to detect a difference between C213 doses and placebo. The protocol was amended to allow for feasible assessments to be done virtually and permit in home monthly pregnancy testing. The monitoring plan and Zosano Pharma vendor management plan were updated to allow for remote monitoring.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Who Achieve Pain Relief | 15 minutes | Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication. |
| Primary | Percentage of Subjects Who Achieve Sustained Pain Relief | 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 | Percentage of Subjects That Achieve Pain Relief | 5 minutes | Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication. |
| Secondary | Percentage of Subjects That Achieve Sustained Pain Relief | 5 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. |
| Secondary | Percentage of Subjects That Achieve Pain Freedom | 10 minutes | Pain freedom is defined by a decrease in pain from severe to none without the use of acute rescue medication. |
| Secondary | Percentage of Subjects That Achieve Sustained Pain Freedom | 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. |
| Secondary | Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject | within 20 minutes | Whether or not subjects were able to perform their usual daily activities was assessed by subject responses (Yes or No) in the electronic diary (eDiary) to the question, "Do you feel able to perform your usual daily activities?" If a subject responded "Yes" but had used a rescue medication, the subject was considered as not being able to perform the usual daily activities. |
| Secondary | Percentage of Subjects That Achieve Pain Relief | 10 minutes | Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication |
| Secondary | Percentage of Subjects That Achieve Pain Relief | 20 minutes | Pain relief is defined by a decrease in pain from severe to mild or none without the use of acute rescue medication. |
| Secondary | Percentage of Subjects That Achieve Sustained Pain Relief | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Who Achieve Pain Relief | 15 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Subjects Who Achieve Sustained Pain Relief | 15 minutes to 60 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects That Achieve Pain Relief | 5 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects That Achieve Sustained Pain Relief | 5 minutes to 60 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects That Achieve Pain Freedom | 10 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects That Achieve Sustained Pain Freedom | 15 to 60 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects Able to Perform Their Usual Daily Activities as Assessed by the Subject | within 20 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects That Achieve Pain Relief | 10 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects That Achieve Pain Relief | 20 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of Subjects That Achieve Sustained Pain Relief | 10 minutes to 60 minutes | Modified Intent-to-treat Population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Who Achieve Pain Relief | Placebo | 3 | Participants | ||
| Percentage of Subjects Who Achieve Pain Relief | C213 1.9 mg | 5 | Participants | ||
| Percentage of Subjects Who Achieve Pain Relief | C213 3.8mg | 5 | Participants | ||
| Percentage of Subjects Who Achieve Sustained Pain Relief | Placebo | 3 | Participants | ||
| Percentage of Subjects Who Achieve Sustained Pain Relief | C213 1.9 mg | 4 | Participants | ||
| Percentage of Subjects Who Achieve Sustained Pain Relief | C213 3.8mg | 5 | Participants | ||
| Percentage of Subjects That Achieve Pain Relief | Placebo | 0 | Participants | ||
| Percentage of Subjects That Achieve Pain Relief | C213 1.9 mg | 2 | Participants | ||
| Percentage of Subjects That Achieve Pain Relief | C213 3.8mg | 1 | Participants | ||
| Percentage of Subjects That Achieve Sustained Pain Relief | Placebo | 0 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | C213 1.9 mg | 17 | |
| Overall Study | STARTED | C213 3.8mg | 13 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | COMPLETED | C213 1.9 mg | 9 | |
| Overall Study | COMPLETED | C213 3.8mg | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | C213 1.9 mg | 8 | |
| Overall Study | NOT COMPLETED | C213 3.8mg | 6 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sunburn | Injury, poisoning and procedural complications | Placebo | 1 | 9 | 1 |
| other | Sunburn | Injury, poisoning and procedural complications | C213 1.9 mg | 0 | 9 | 0 |
| other | Sunburn | Injury, poisoning and procedural complications | C213 3.8mg | 0 | 7 | 0 |
| other | Application site erythema | General disorders | Placebo | 1 | 9 | 1 |
| other | Application site erythema | General disorders | C213 1.9 mg | 2 | 9 | 2 |
| other | Application site erythema | General disorders | C213 3.8mg | 0 | 7 | 0 |
| other | Application site oedema | General disorders | Placebo | 1 | 9 | 1 |
| other | Application site oedema | General disorders | C213 1.9 mg | 0 | 9 | 0 |
| other | Application site oedema | General disorders | C213 3.8mg | 0 | 7 | 0 |
| other | Application site bruise | General disorders | Placebo | 0 | 9 | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 9 |
| Total, all-cause mortality | C213 1.9 mg | 0 | 9 |
| Total, all-cause mortality | C213 3.8mg | 0 | 7 |
| Total, other adverse events | Placebo | 1 | 9 |
| Total, other adverse events | C213 1.9 mg | 4 | 9 |
| Total, other adverse events | C213 3.8mg | 2 | 7 |
| Total, serious adverse events | Placebo | 0 | 9 |
| Total, serious adverse events | C213 1.9 mg | 0 | 9 |
| Total, serious adverse events | C213 3.8mg | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04066023
GET https://conductscience.org/api/trials/v1/NCT04066023/results?page=2