Adults 6 to 17, any sex, with Migraine Disorders. 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.
Safety and Tolerability of Single Doses of Rizatriptan in Pediatric MigraineursPrimary· 24 Hours
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram) and laboratory safety tests (hematology/blood chemistry/urinalysis)
Serious Adverse Events
Group
Value
95% CI
Rizatriptan 5 mg
0
Rizatriptan 10 mg
0
Placebo
0
Non-Serious Adverse Events
Group
Value
95% CI
Rizatriptan 5 mg
3
Rizatriptan 10 mg
7
Placebo
3
No Adverse Events Reported
Group
Value
95% CI
Rizatriptan 5 mg
7
Rizatriptan 10 mg
7
Placebo
4
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan- Area Under the Curve (AUC(0-∞))Secondary· 24 Hours
Preliminary pharmacokinetics data; Area Under the Curve (AUC(0-∞)); i.e., area under the concentration-time plot
Group
Value
95% CI
Panel A Rizatriptan
59.4
± 11.5
Panel B Rizatriptan
84.0
± 19.8
Panel C Rizatriptan
67.93
± 25.17
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Maximum Concentration (Cmax)Secondary· 24 Hours
Preliminary pharmacokinetics data; Maximum concentration (Cmax); i.e, highest concentration of drug achieved
Group
Value
95% CI
Panel A Rizatriptan
24.6
± 7.2
Panel B Rizatriptan
25.0
± 8.1
Panel C Rizatriptan
18.4
± 5.5
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Time to Maximum Concentration (Tmax)Secondary· 24 Hours
Preliminary pharmacokinetics data; Time to maximum concentration (Tmax); i.e., amount of time required to reach maximum concentration
Group
Value
95% CI
Panel A Rizatriptan
1.0
0.3 – 2.0
Panel B Rizatriptan
1.5
0.3 – 3.0
Panel C Rizatriptan
1.3
0.7 – 1.7
Preliminary Pharmacokinetic Data Following Single Dose Administration of Rizatriptan - Apparent Half-life (Apparent t½)Secondary· 24 Hours
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.
After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT07170176 — Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
· NA
· recruiting
NCT07093138 — Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatmen
· Phase 4
· recruiting
NCT06426316 — The Role of Cytokines and Regulatory T Lymphocytes in Migraine Pathophysiology.
· NA
· recruiting
NCT06623188 — Treatment of Episodic Migraine With AURICular Neuromodulation
· NA
· recruiting
NCT06535880 — Trigeminal Brainstem Mapping 2: Higher Cortical Strucureas As Well As Subnuclei of the Spinal Trigeminal Nucleus
· NA
· recruiting
Other Organon and Co trials
Trials by the same sponsor.
NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
· Phase 4
· completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi
· Phase 4
· completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
· Phase 4
· completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18
· Phase 2
· completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive
· Phase 3
· terminated
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 19 April 2024
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/NCT00604812.