Clinical Trials List
Protocol NumberCAMG334A2302
2018-02-01 - 2020-05-30
Phase III
Terminated8
Study ended1
ICD-10G44.219
Episodic tension-type headache, not intractable
ICD-9307.81
Tension headache
A 12-week double-blind, randomized, multi-center study comparing the efficacy and safety of once monthly subcutaneous AMG 334 against placebo in adult episodic migraine patients (EMPOwER)
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- YEN-FENG WANG 無
- 陳世彬 無
- 陳韋達 無
- Hung-Yu Liu 無
- 賴冠霖 無
- 陳世彬 未分科
- Jong-Ling Fuh 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Linkou Chang Gung Medical Foundation
Taiwan National PI
羅榮昇
Co-Principal Investigator
- Hong-Chou Kuo 無
- 廖洺鋒 無
- 呂榮國 無
- 朱俊哲 無
- Chin-Chang Huang 無
- 張宏旭 無
- 張國軒 無
The Actual Total Number of Participants Enrolled
11 Terminated
Audit
None
Co-Principal Investigator
- 陳炳錕 無
The Actual Total Number of Participants Enrolled
18 Study ended
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Episodic Migraine
Objectives
The primary objective is to evaluate the effect of AMG 334 compared to placebo by measuring the change in monthly migraine days from baseline to the last month (Month 3) of the double-blind treatment period (DBTP)
Test Drug
AMG334
Active Ingredient
Erenumab
Dosage Form
solution for injection in prefilled syringe
Dosage
70mg/ml
Endpoints
The primary objective is to evaluate the effect of AMG 334 compared to placebo by measuring the change in monthly migraine days from baseline to the last month (Month 3) of the double-blind treatment period (DBTP)
Secondary Objectives
Objective 1: To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects as measured by the achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3
Objective 2: To evaluate the effect of AMG 334 compared to placebo as measured by the change from baseline in monthly acute migraine-specific medication treatment days at Month 3.
Objective 3: To evaluate the safety and tolerability of AMG 334 as measured by adverse event frequency,
clinical laboratory value changes, vital sign changes, and the presences of anti-AMG 334 antibodies
Objective 4: To evaluate the effect of AMG 334 compared to placebo on change from baseline in headache impact scores as measured by change from baseline in headache impact scores as measured by the Headache Impact Test (HIT-6) at Month 3
Secondary Objectives
Objective 1: To evaluate the effect of AMG 334 compared to placebo on the proportion of subjects as measured by the achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3
Objective 2: To evaluate the effect of AMG 334 compared to placebo as measured by the change from baseline in monthly acute migraine-specific medication treatment days at Month 3.
Objective 3: To evaluate the safety and tolerability of AMG 334 as measured by adverse event frequency,
clinical laboratory value changes, vital sign changes, and the presences of anti-AMG 334 antibodies
Objective 4: To evaluate the effect of AMG 334 compared to placebo on change from baseline in headache impact scores as measured by change from baseline in headache impact scores as measured by the Headache Impact Test (HIT-6) at Month 3
Inclution Criteria
1. Written informed consent must be obtained before any assessment is performed.
2. Adults ≥ 18 to ≤ 65 years of age upon entry into screening
3. History of migraine (with or without aura) for ≥ 12 months prior to screening according to the HIS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self-report
4. Migraine frequency 4 to 14 migraine days per month on average across the 3 months prior to screening (refer to Section 6.4.1 for the definition of migraine day)
5. Headache (ie, migraine and non-migraine headache) frequency < 15 headache days per month on average across the 3 months prior to screening (refer to Section 6.6.1 for the definition of headache day)
6. Migraine frequency 4 to 14 migraine days during the baseline period based on the eDiary calculations
7. Headache frequency < 15 headache days during the baseline period based on the eDiary calculations
8. Demonstrated at least 80% compliance with the eDiary (for example, completing eDiary items for at least 23 out of 28 days during the baseline period)
2. Adults ≥ 18 to ≤ 65 years of age upon entry into screening
3. History of migraine (with or without aura) for ≥ 12 months prior to screening according to the HIS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self-report
4. Migraine frequency 4 to 14 migraine days per month on average across the 3 months prior to screening (refer to Section 6.4.1 for the definition of migraine day)
5. Headache (ie, migraine and non-migraine headache) frequency < 15 headache days per month on average across the 3 months prior to screening (refer to Section 6.6.1 for the definition of headache day)
6. Migraine frequency 4 to 14 migraine days during the baseline period based on the eDiary calculations
7. Headache frequency < 15 headache days during the baseline period based on the eDiary calculations
8. Demonstrated at least 80% compliance with the eDiary (for example, completing eDiary items for at least 23 out of 28 days during the baseline period)
Exclusion Criteria
1. Older than 50 years of age at migraine onset
2. History of cluster headache or hemiplegic migraine headache
3. Unable to differentiate migraine from other headaches
4. No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of
migraine after an adequate therapeutic trial. These medication categories are:
• Category 1: Divalproex sodium, sodium valproate
• Category 2: Topiramate
• Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol,
propranolol, timolol)
• Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
• Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine,
duloxetine, milnacipran)
• Category 6: Flunarizine, verapamil
• Category 7: Lisinopril, candesartan
No therapeutic response is defined as no reduction in headache frequency, duration, or severity after
administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on
the investigator’s assessment.
The following scenarios do not constitute lack of therapeutic response:
• Lack of sustained response to a medication
• Failure to tolerate a therapeutic dose
5. Used a prohibited medication, device, or procedure within 2 months prior to the start of or during the baseline
period, or during the DBTP (Refer to Section 5.5.8 for the list of these excluded treatments)
6. Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline
period or during the baseline period
7. Taken the following for any indication in any month during the 2 months prior to the start of the baseline
period:
• Ergotamines or triptans on ≥ 10 days per month, or
• Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per
month, or
• Opioid- or butalbital-containing analgesics on ≥ 4 days per month
8. Anticipated to require any excluded medication, device, or procedure during the study (Refer to Section 5.5.8
for the lists of these medications, devices, and procedures). Traditional medications and/or procedures are
allowed if used at a stable dose/frequency for at least three months prior to randomization, and during the study
9. Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)
10. History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of
depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety
disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator
to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable
dose within the 3 months prior to the start of the baseline period.
11. History of seizure disorder or other significant neurological conditions other than migraine. Note: A single
childhood febrile seizure is not exclusionary.
12. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ
cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.
13. Human immunodeficiency virus (HIV) infection by history
14. Hepatic disease by history or total bilirubin ≥ 2.0 x upper limit of normal (ULN) or alanine transaminase
(ALT) or aspartate aminotransferase (AST) ≥ 3.0 x ULN, as assessed by the central laboratory at initial
screening
15. Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery
bypass surgery or other revascularization procedure within 12 months prior to screening
16. History or evidence of any other unstable or clinically significant medical condition, that in the opinion of the
investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
17. Subject has any clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during
screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the studyevaluation
18. Score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating
Scale (C-SSRS), if this ideation occurred in the past 6 months, or “yes” on any item of the Suicidal Behavior
section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior
section), if this behavior occurred in the past 2 years.
19. Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical
records, patient self-report, or positive urine drug test performed during screening (with the exception of
prescribed medications such as opioids or barbiturates)
20. Pregnant or nursing (lactating) women
21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant,
unless they are using basic methods of contraception during dosing of investigational drug. Basic contraception
methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic
abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total
hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of
oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up
hormone level assessment
• Male sterilization (at least 6 m prior to screening). For female subjects on the study, the vasectomized
male partner should be the sole partner for that subject
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For
UK: with spermicidal foam/gel/film/cream/vaginal suppository
• Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or
other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example
hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device
(IUD) or intrauterine system
• (IUS)
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3
months before taking investigational drug.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of
natural (spontaneous) amenorrhea with an appropriate clinical profile (eg age appropriate, history of vasomotor
symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or
tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of
the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing
potential.
22. Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic
effect has returned to baseline, whichever is longer.
23. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
24. Previously randomized into an AMG 334 study
25. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all
required study procedures (eg, independent completion of electronic diary [eDiary] items) to the best of the
subject’s and investigator’s knowledge. No additional exclusions may be applied by the investigator, in order to
ensure that the study population will be representative of all eligible patients.
2. History of cluster headache or hemiplegic migraine headache
3. Unable to differentiate migraine from other headaches
4. No therapeutic response with > 2 of the following 7 medication categories for prophylactic treatment of
migraine after an adequate therapeutic trial. These medication categories are:
• Category 1: Divalproex sodium, sodium valproate
• Category 2: Topiramate
• Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol,
propranolol, timolol)
• Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)
• Category 5: Serotonin-norepinephrine reuptake inhibitors (for example: venlafaxine, desvenlafaxine,
duloxetine, milnacipran)
• Category 6: Flunarizine, verapamil
• Category 7: Lisinopril, candesartan
No therapeutic response is defined as no reduction in headache frequency, duration, or severity after
administration of the medication for at least 6 weeks at the generally accepted therapeutic dose(s) based on
the investigator’s assessment.
The following scenarios do not constitute lack of therapeutic response:
• Lack of sustained response to a medication
• Failure to tolerate a therapeutic dose
5. Used a prohibited medication, device, or procedure within 2 months prior to the start of or during the baseline
period, or during the DBTP (Refer to Section 5.5.8 for the list of these excluded treatments)
6. Received botulinum toxin in the head and/or neck region within 4 months prior to the start of the baseline
period or during the baseline period
7. Taken the following for any indication in any month during the 2 months prior to the start of the baseline
period:
• Ergotamines or triptans on ≥ 10 days per month, or
• Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs], acetaminophen) on ≥ 15 days per
month, or
• Opioid- or butalbital-containing analgesics on ≥ 4 days per month
8. Anticipated to require any excluded medication, device, or procedure during the study (Refer to Section 5.5.8
for the lists of these medications, devices, and procedures). Traditional medications and/or procedures are
allowed if used at a stable dose/frequency for at least three months prior to randomization, and during the study
9. Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain)
10. History of major psychiatric disorder (such as schizophrenia and bipolar disorder), or current evidence of
depression based on a Beck Depression Inventory (BDI)-II total score > 19 at screening. Subjects with anxiety
disorder and/or major depressive disorder are permitted in the study if they are considered by the investigator
to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable
dose within the 3 months prior to the start of the baseline period.
11. History of seizure disorder or other significant neurological conditions other than migraine. Note: A single
childhood febrile seizure is not exclusionary.
12. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ
cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.
13. Human immunodeficiency virus (HIV) infection by history
14. Hepatic disease by history or total bilirubin ≥ 2.0 x upper limit of normal (ULN) or alanine transaminase
(ALT) or aspartate aminotransferase (AST) ≥ 3.0 x ULN, as assessed by the central laboratory at initial
screening
15. Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery
bypass surgery or other revascularization procedure within 12 months prior to screening
16. History or evidence of any other unstable or clinically significant medical condition, that in the opinion of the
investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
17. Subject has any clinically significant vital sign, laboratory, or electrocardiogram (ECG) abnormality during
screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the studyevaluation
18. Score “yes” on item 4 or item 5 of the Suicidal Ideation section of the Columbia Suicide Severity Rating
Scale (C-SSRS), if this ideation occurred in the past 6 months, or “yes” on any item of the Suicidal Behavior
section, except for the “Non-Suicidal Self-Injurious Behavior” (item also included in the Suicidal Behavior
section), if this behavior occurred in the past 2 years.
19. Evidence of drug or alcohol abuse or dependence within 12 months prior to screening, based on medical
records, patient self-report, or positive urine drug test performed during screening (with the exception of
prescribed medications such as opioids or barbiturates)
20. Pregnant or nursing (lactating) women
21. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant,
unless they are using basic methods of contraception during dosing of investigational drug. Basic contraception
methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic
abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total
hysterectomy or tubal ligation at least six weeks before taking investigational drug. In case of
oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up
hormone level assessment
• Male sterilization (at least 6 m prior to screening). For female subjects on the study, the vasectomized
male partner should be the sole partner for that subject
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For
UK: with spermicidal foam/gel/film/cream/vaginal suppository
• Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or
other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example
hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device
(IUD) or intrauterine system
• (IUS)
In case of use of oral contraception women should have been stable on the same pill for a minimum of 3
months before taking investigational drug.
Women are considered post-menopausal and not of child bearing potential if they have had 12 months of
natural (spontaneous) amenorrhea with an appropriate clinical profile (eg age appropriate, history of vasomotor
symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or
tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of
the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing
potential.
22. Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic
effect has returned to baseline, whichever is longer.
23. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
24. Previously randomized into an AMG 334 study
25. Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all
required study procedures (eg, independent completion of electronic diary [eDiary] items) to the best of the
subject’s and investigator’s knowledge. No additional exclusions may be applied by the investigator, in order to
ensure that the study population will be representative of all eligible patients.
The Estimated Number of Participants
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Taiwan
130 participants
-
Global
880 participants
