Efficacy and Safety of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Chronic Migraine

NCT03303079 | Completed Phase 2 Results

• 2 other identifiers: 406-102-00001JapicCTI-173723
• Study Type: interventional
• Target: 571
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of subcutaneous (SC) administration of TEV-48125 \[monthly TEV-48125 225 mg (loading dose only: 675 mg) and TEV-48125 675 mg once over a period of 3 months\] compared with placebo for preventive treatment in Chronic Migraine patients

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of Investigational Medicinal Product (IMP)

  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, 12 weeks

Secondary Outcomes (5)

• Mean Change From Baseline in the Monthly Average Number of Migraine Days During the 12-week Period After the First Dose of IMP

  Baseline, 12 weeks

• Proportion of Subjects Reaching at Least 50% Reduction in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP

  12 weeks

• Mean Change From Baseline in the Monthly Average Number of Days With Use of Any Acute Headache Medications During the 12-week Period After the First Dose of IMP

  Baseline, 12 weeks

• Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-week Period After the First Dose of IMP in Subjects Not Receiving Concomitant Preventive Migraine Medications

  Baseline, 12 weeks

• Mean Change From Baseline in Disability Score, as Measured by 6-Item Headache Impact Test (HIT-6) at 4 Weeks After the Final (Third) Dose of IMP

  Baseline, 4 weeks

Study Arms (3)

TEV-48125 (675/225/225 mg) group

EXPERIMENTAL

TEV-48125 will be subcutaneously administered once monthly for 3 months (675/225/225 mg).

Drug: TEV-48125

TEV-48125 (675 mg/placebo/placebo) group

EXPERIMENTAL

TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months (675 mg/ placebo/placebo).

Drug: TEV-48125 or placebo

Placebo group

PLACEBO COMPARATOR

Placebo will be subcutaneously administered once monthly for 3 months (placebo/placebo/placebo).

Drug: Placebo

Interventions

TEV-48125 DRUG

TEV-48125 will be subcutaneously administered once monthly for 3 months.

TEV-48125 (675/225/225 mg) group

TEV-48125 or placebo DRUG

TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.

TEV-48125 (675 mg/placebo/placebo) group

Placebo DRUG

Placebo will be subcutaneously administered once monthly for 3 months.

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 1 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.

You may not qualify if:

• Patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses
• Patient suffers from unremitting headaches, defined as having headaches for more than 80% of the time that he/she is awake, and less than 4 days without headache per month. Daily headache is acceptable if the patient has headaches 80% or less of the time they are awake on most days.
• Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Saitama Medical University Hospital

Iruma, Japan

Location

Related Publications (1)

• Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X, Koga N. Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain. 2022 Feb 9;23(1):24. doi: 10.1186/s10194-022-01393-0.

  PMID: 35139816 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

CL_OPCJ_RDA_Team@otsuka.jp

+81-3-6361-7366

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 5, 2017
• Study Start: December 19, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

JP (1)