Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

Migraine Clinical Trial

Official title:

A Multicenter, Randomized, Open-label Trial Evaluating the Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03303105
• Other study ID #: 406-102-00003
• Secondary ID: JapicCTI-173726
• Status: Completed
• Phase: Phase 3
• Start date: December 7, 2017
• Est. completion date: June 16, 2020

Study information

• Verified date: February 2023
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 16, 2020
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition [beta version] criteria) or clinical judgment suggests a migraine diagnosis

• Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period

• Not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.

• Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion Criteria:

• Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• TEV-48125
TEV-48125 will be administered subcutaneously once every 4 weeks.
• TEV-48125
TEV-48125 will be administered subcutaneously once every 12 weeks.

Locations

Country	Name	City	State
Japan	Saitama Medical University Hospital	Iruma

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)	TEAEs are defined as the AEs that started after trial investigational medicinal product (IMP) treatment. Multiple occurrences of TEAEs are counted once per MedDRA preferred term.; Specific AE terms are provided in the Adverse Event section.	Baseline (Day 0) up to follow-up visit (Day 562)
Secondary	Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days	Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.; Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.	Baseline, Month 12
Secondary	Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity	Headache-related efficacy endpoints were derived from headache variables collected using an eDiary. On each day, subjects entered headache data in the electronic headache diary for the previous 24-hour period. Subjects who had experienced headache on the previous day answered questions about the headache (ie, occurrence of headache, duration of headache, maximum severity of headache, presence/absence of associated symptoms, and use of acute headache medications). Overall headache duration was recorded numerically, in hours, as well as number of hours with headache of at least moderate severity. If headache was reported, then headache severity was subjectively rated by the subject as mild, moderate, or severe.; Subjects also recorded the presence or absence of photophobia, phonophobia, nausea, or vomiting, and the status of use of any acute headache medications.	Baseline, Month 12