Trial Outcomes & Findings for Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine (NCT NCT03303105)
NCT ID: NCT03303105
Last Updated: 2023-02-17
Results Overview
* 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.
COMPLETED
PHASE3
50 participants
Baseline (Day 0) up to follow-up visit (Day 562)
2023-02-17
Participant Flow
Participant milestones
| Measure |
TEV-48125 (225 mg/1 Month) Group
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
TEV-48125 (225 mg/1 Month) Group
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Baseline characteristics by cohort
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=25 Participants
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=25 Participants
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
46.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to follow-up visit (Day 562)Population: Safety Set (SS): Newly enrolled subjects who received the IMP at least once
* 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.
Outcome measures
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=25 Participants
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=25 Participants
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Percentage of Subjects With at Least One Treatment-Emergent Adverse Event (TEAE)
|
92.0 percentage of participants
|
88.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available
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.
Outcome measures
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=23 Participants
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=22 Participants
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Mean Change From Baseline in the Monthly (28 Day) Average Number of Migraine Days
|
-5.9 days/month
Standard Deviation 4.3
|
-1.6 days/month
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis set (FAS): Newly enrolled subjects for whom electronic headache diary efficacy assessment data at baseline and after the first dose of IMP were available
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.
Outcome measures
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=23 Participants
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=22 Participants
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Mean Change From Baseline in the Monthly (28 Day) Average Number of Headache Days of at Least Moderate Severity
|
-4.3 days/month
Standard Deviation 4.1
|
-2.1 days/month
Standard Deviation 4.1
|
Adverse Events
TEV-48125 (225 mg/1 Month) Group
TEV-48125 (675 mg/3 Month) Group
Serious adverse events
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=25 participants at risk
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=25 participants at risk
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
Eye disorders
Rhegmatogenous retinal detachment
|
0.00%
0/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
Other adverse events
| Measure |
TEV-48125 (225 mg/1 Month) Group
n=25 participants at risk
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 chronic migraine).
|
TEV-48125 (675 mg/3 Month) Group
n=25 participants at risk
TEV-48125 will be administered subcutaneously once every 12 weeks for a total of 5 doses (at 675 mg once every 3 months).
|
|---|---|---|
|
General disorders
Injection site pruritus
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
General disorders
Injection site induration
|
12.0%
3/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
General disorders
Injection site erythema
|
28.0%
7/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
20.0%
5/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
General disorders
Injection site pain
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
12.0%
3/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Infections and infestations
Influenza
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Infections and infestations
Gastroenteritis
|
12.0%
3/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Infections and infestations
Oral herpes
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Infections and infestations
Nasopharyngitis
|
72.0%
18/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
56.0%
14/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.0%
2/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
4.0%
1/25 • Baseline (Day 0) up to follow-up visit (Day 562)
Safety Set (SS): Newly enrolled subjects who received the IMP at least once
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., LTD.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place