18 and older, any sex, with Migraine, With or Without Aura. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With SAEs and AEs Leading to Discontinuation During the Treatment PeriodPrimary· 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 rimeg
Overall number of participants with at least 1 AE
Group
Value
95% CI
PRN (2-8) Group
664
PRN (9-14) Group
315
Scheduled EOD + PRN Group
109
AE ≥5%-Upper respiratory tract infection
Group
Value
95% CI
PRN (2-8) Group
108
PRN (9-14) Group
38
Scheduled EOD + PRN Group
12
Mild-Upper respiratory tract infection
Group
Value
95% CI
PRN (2-8) Group
56
PRN (9-14) Group
21
Scheduled EOD + PRN Group
8
Moderate-Upper respiratory tract infection
Group
Value
95% CI
PRN (2-8) Group
51
PRN (9-14) Group
17
Scheduled EOD + PRN Group
4
Severe-Upper respiratory tract infection
Group
Value
95% CI
PRN (2-8) Group
1
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
AE ≥5%-Nasopharyngitis
Group
Value
95% CI
PRN (2-8) Group
72
PRN (9-14) Group
41
Scheduled EOD + PRN Group
9
Mild-Nasopharyngitis
Group
Value
95% CI
PRN (2-8) Group
53
PRN (9-14) Group
28
Scheduled EOD + PRN Group
7
Moderate-Nasopharyngitis
Group
Value
95% CI
PRN (2-8) Group
19
PRN (9-14) Group
13
Scheduled EOD + PRN Group
2
Number of Participants With Clinically Significant Laboratory Abnormalities During the Treatment PeriodPrimary· 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
Alanine Aminotransferase (ALT)
Group
Value
95% CI
PRN (2-8) Group
3
PRN (9-14) Group
2
Scheduled EOD + PRN Group
0
Aspartate Aminotransferase (AST)
Group
Value
95% CI
PRN (2-8) Group
4
PRN (9-14) Group
2
Scheduled EOD + PRN Group
0
Albumin
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
Alkaline Phosphatase
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
Bicarbonate
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
Bilirubin
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
Calcium, Low
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
Calcium, High
Group
Value
95% CI
PRN (2-8) Group
0
PRN (9-14) Group
0
Scheduled EOD + PRN Group
0
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 PeriodSecondary· 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.
Group
Value
95% CI
PRN (2-8) Group
0.1
0.00 – 0.60
PRN (9-14) Group
0
0.00 – 0.96
Scheduled EOD + PRN Group
0
0.00 – 1.60
Number of Participants With Hepatic-related AEs and Hepatic-related AEs Leading to Discontinuation During the Treatment PeriodSecondary· 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.
Hepatic-related AE
Group
Value
95% CI
PRN (2-8) Group
16
PRN (9-14) Group
10
Scheduled EOD + PRN Group
0
Hepatic-related AE leading to discontinuation
Group
Value
95% CI
PRN (2-8) Group
3
PRN (9-14) Group
3
Scheduled EOD + PRN Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from start of study drug treatment up to 52 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 16 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03266588.