Trial · NCT03266588
Open Label Safety Study in Acute Treatment of Migraine
NCT03266588, Phase 2, Phase 3, Completed, Pfizer; results first posted 2020-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Safety Study in Acute Treatment of Migraine. Trials, record NCT03266588. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03266588
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Safety Study in Acute Treatment of Migraine
- NCT number
- NCT03266588
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 3,019 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Migraine, With or Without Aura
- Interventions
- Rimegepant
- First posted
- 2017-08-30
- Last updated
- 2023-02-16
- Results first posted
- 2020-07-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational (medicinal) product and that did not necessarily have a causal relationship with this treatment. An SAE was defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received rimegepant; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention. |
| Primary | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks | Clinically significant laboratory abnormalities were defined as Grade 3 to 4 on-treatment laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0 (2017) if available; otherwise, according to Division of Acquired Immune Deficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1 (2017) for Glucose, LDL-Cholesterol, Uric Acid, and Urinalysis. Laboratory test groups of clinical interest included hematology, serum chemistry, and urinalysis. Participants must have had a non-missing measurement in the on-treatment period to be included for a given parameter. |
| Secondary | Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | Elevations of on-treatment AST or ALT \> 3 x ULN concurrent with total bilirubin \> 2 x ULN were defined as elevations on the same collection date. |
| Secondary | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation patient administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. Hepatic AEs were defined as all on-treatment PTs under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those PTs in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | The analysis was performed on treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks: Scheduled EOD + PRN group: Up to 12 weeks | The analysis was performed on treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Elevations of AST or ALT > 3 x Upper Limit of Normal (ULN) Concurrent With Total Bilirubin > 2 x ULN During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | The analysis was performed on treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) and PRN (9-14) groups: Up to 52 weeks; Scheduled EOD + PRN group: Up to 12 weeks | The analysis was performed on treated participants. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) Group | Overall number of participants with at least 1 AE | 664 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (9-14) Group | Overall number of participants with at least 1 AE | 315 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Scheduled EOD + PRN Group | Overall number of participants with at least 1 AE | 109 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) Group | AE ≥5%-Upper respiratory tract infection | 108 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (9-14) Group | AE ≥5%-Upper respiratory tract infection | 38 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Scheduled EOD + PRN Group | AE ≥5%-Upper respiratory tract infection | 12 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) Group | Mild-Upper respiratory tract infection | 56 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (9-14) Group | Mild-Upper respiratory tract infection | 21 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | Scheduled EOD + PRN Group | Mild-Upper respiratory tract infection | 8 | Participants | |
| Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment Period | PRN (2-8) Group | Moderate-Upper respiratory tract infection | 51 | Participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Observational Period | STARTED | PRN (2-8) Group | 1,605 | |
| Observational Period | STARTED | PRN (9-14) Group | 786 | |
| Observational Period | STARTED | Scheduled EOD + PRN Group | 476 | |
| Observational Period | COMPLETED | PRN (2-8) Group | 1,089 | |
| Observational Period | COMPLETED | PRN (9-14) Group | 511 | |
| Observational Period | COMPLETED | Scheduled EOD + PRN Group | 308 | |
| Observational Period | NOT COMPLETED | PRN (2-8) Group | 516 | |
| Observational Period | NOT COMPLETED | PRN (9-14) Group | 275 | |
| Observational Period | NOT COMPLETED | Scheduled EOD + PRN Group | 168 | |
| Long-term Treatment Period | STARTED | PRN (2-8) Group | 1,089 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events135
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 | Nasopharyngitis | Infections and infestations | PRN (2-8) Group | 72 | 1,033 | |
| other | Nasopharyngitis | Infections and infestations | PRN (9-14) Group | 41 | 481 | |
| other | Nasopharyngitis | Infections and infestations | Scheduled EOD + PRN Group | 9 | 286 | |
| other | Sinusitis | Infections and infestations | PRN (2-8) Group | 57 | 1,033 | |
| other | Sinusitis | Infections and infestations | PRN (9-14) Group | 28 | 481 | |
| other | Sinusitis | Infections and infestations | Scheduled EOD + PRN Group | 7 | 286 | |
| other | Upper respiratory tract infection | Infections and infestations | PRN (2-8) Group | 108 | 1,033 | |
| other | Upper respiratory tract infection | Infections and infestations | PRN (9-14) Group | 38 | 481 | |
| other | Upper respiratory tract infection | Infections and infestations | Scheduled EOD + PRN Group | 12 | 286 | |
| serious | Anaemia | Blood and lymphatic system disorders | PRN (2-8) Group | 1 | 1,033 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PRN (2-8) Group | 0 | 1,033 |
| Total, all-cause mortality | PRN (9-14) Group | 0 | 481 |
| Total, all-cause mortality | Scheduled EOD + PRN Group | 0 | 286 |
| Total, other adverse events | PRN (2-8) Group | 224 | 1,033 |
| Total, other adverse events | PRN (9-14) Group | 100 | 481 |
| Total, other adverse events | Scheduled EOD + PRN Group | 27 | 286 |
| Total, serious adverse events | PRN (2-8) Group | 28 | 1,033 |
| Total, serious adverse events | PRN (9-14) Group | 16 | 481 |
| Total, serious adverse events | Scheduled EOD + PRN Group | 3 | 286 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
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/NCT03266588
GET https://conductscience.org/api/trials/v1/NCT03266588/results?page=2