A Phase 3 interventional study of TEV-48125 and TEV-48125 in Migraine, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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
Exclusion Criteria:
TEV-48125 will be administered subcutaneously once every 4 weeks for a total of 13 doses (at 225 mg once monthly \[except for a loading dose of 675 mg in subjects with CM\]).
Drug: TEV-48125
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
Drug: TEV-48125
TEV-48125 will be administered subcutaneously once every 4 weeks.
TEV-48125 will be administered subcutaneously once every 12 weeks.
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.
Time frame: Baseline (Day 0) up to follow-up visit (Day 562)
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.
Time frame: Baseline, Month 12
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.
Time frame: Baseline, Month 12
| Milestone | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| Started | 25 | 25 |
| Completed | 23 | 21 |
| Not completed | 2 | 4 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
* 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.
| percentage of participants | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE) | 92.0 | 88.0 |
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.
| days/month | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days | -5.9 ± 4.3 | -1.6 ± 5.7 |
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.
| days/month | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity | -4.3 ± 4.1 | -2.1 ± 4.1 |
Collected over Baseline (Day 0) up to follow-up visit (Day 562). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TEV-48125 (225 mg/1 Month) Group | 0/25 (0%) | 0/25 (0%) | 20/25 (80%) |
| TEV-48125 (675 mg/3 Month) Group | 0/25 (0%) | 2/25 (8%) | 16/25 (64%) |
| Event | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| Rhegmatogenous retinal detachmentEye disorders | 0/25 | 1/25 |
| Subarachnoid haemorrhageNervous system disorders | 0/25 | 1/25 |
| Event | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group |
|---|---|---|
| NasopharyngitisInfections and infestations | 18/25 | 14/25 |
| Injection site erythemaGeneral disorders | 7/25 | 5/25 |
| Injection site indurationGeneral disorders | 3/25 | 2/25 |
| Injection site painGeneral disorders | 1/25 | 3/25 |
| GastroenteritisInfections and infestations | 3/25 | 1/25 |
| Injection site pruritusGeneral disorders | 2/25 | 1/25 |
| InfluenzaInfections and infestations | 1/25 | 2/25 |
| Oral herpesInfections and infestations | 1/25 | 2/25 |
| Back painMusculoskeletal and connective tissue disorders | 1/25 | 2/25 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/25 | 2/25 |
| Age, Categorical(Participants) | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 25 | 49 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group | Total |
|---|---|---|---|
| Mean | 46.8 ± 7.9 | 45.8 ± 7.0 | 46.3 ± 7.4 |
| Sex: Female, Male(Participants) | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group | Total |
|---|---|---|---|
| Female | 23 | 19 | 42 |
| Male | 2 | 6 | 8 |
| Race/Ethnicity, Customized(Participants) | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group | Total |
|---|---|---|---|
| Japanese | 25 | 25 | 50 |
| Region of Enrollment(Participants) | TEV-48125 (225 mg/1 Month) Group | TEV-48125 (675 mg/3 Month) Group | Total |
|---|---|---|---|
| Japan | 25 | 25 | 50 |
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Otsuka Pharmaceutical Co., Ltd.