A Single-Dose, Open-Label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Administration of Fremanezumab in Pediatric Migraine Patients (6 to 11 Years of Age Inclusive) Phase 1
Study ID: STU 062018-073
General Study Design and Methodology: This is a multicenter, single-dose, open-label study to characterize the pharmacokinetics, safety and tolerability of sc administration of fremanezumab in pediatric migraine patients (6 to 11 years of age inclusive). up to 15 patients are planned to be enrolled in this study with the intent of attaining at least 12 evaluable patients for the primary analysis. at least 4 patients at body weight [Less Than]30 kg and at least 4 patients at body weight [GreaterThanorequalTo]30 kg will be recruited into the study. every effort will be made to include at least 4 patients from each gender. after completing the informed consent and assent process according to local regulations at the screening visit, eligibility criteria will be confirmed. Patients meeting eligibility criteria during screening and re-confirmed at day -1 will be enrolled into the study, which consists of an inpatient treatment period followed by approximately 4 months of outpatient period. Patien[See protocol for complete text]
Patients may be included in this study only if they meet all of the following criteria: a. Male or female children are 6 to 11 years of age inclusive (at the time of assent of the patient and/or consent of parent(s)/guardian[s]). b. Written informed consent is obtained from each patient[Single Quote]s parent(s) or legal guardian(s) and assent (according to local regulations) is obtained from each patient. c. Patient has been diagnosed with migraine (International Classification of Headache Disorders, ICHD-3; see Appendix D for details). d. Females of childbearing potential must not be sexually active and must have a negative urine beta human chorionic gonadotropin ([BETA]-HCG) test at screening. e. The patient is in good health as determined by a medical and psychiatric history, physical examination, 12-lead ECG, and clinical laboratory tests including serum chemistry, hematology, coagulation, and urinalysis. f. The patient and parent(s)/legal guardian(s) must be willing and able to comply with study restrictions and with the requirement for the patient to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluations as specified in this protocol. g. The patient is able to understand and follow study instructions alone or with parental(s)/legal guardian(s) assistance. h. The patient weighs at least 17.0 kg and less than 45.0 kg.
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- DERYK LEE WALSH
ICON CLINICAL RESEARCH INC
Primary objective: The primary objective of this study is to characterize the pharmacokinetic profile of fremanezumab following administration of a single subcutaneous (sc) dose in pediatric patients with migraine (6 to 11 years of age inclusive). Secondary objective: The secondary objective of the study is to evaluate the safety and tolerability profile of fremanezumab following administration of a single sc dose in pediatric patients with migraine (6 to 11 years of age inclusive).