A Phase 3 interventional study of Erenumab and Placebo in Episodic Migraine, sponsored by Novartis Pharmaceuticals. Completed at 81 sites in 11 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-11.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Prevention
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Among 17 studies testing erenumab in Headache — 1 open to participants now, 2 under way, 1 of them phase 3. erenumab · Headache.
Among the 17 studies testing erenumab in Headache, this one is the 2nd largest by enrollment, is the only one that started in 2018, is one of 8 in phase 3, and was the 7th registered.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
Browse Headache studies →1 of the 17 studies testing erenumab in Headache is open now, in 1 country. Recruiting first, the newest first:
Danish Headache Center · Sites in Denmark
Ages 18+
By country, each count listing its studies:
erenumab: first FDA approval 2018 (AIMOVIG), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 83 Headache studies recruiting now, 30 (36%) set no upper age limit and 44 (53%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2018.
This study's enrollment of 900 is above the median of 65 across 560 interventional studies indexed under Headache.
Median enrollment 475 across the 17 interventional studies. Of the 14 that completed or were terminated, 14 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 17 have an industry lead sponsor. The 4 most frequent:
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis has 7 studies filed under Headache — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 17 studies testing erenumab in Headache, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.
Key inclusion criteria:
Key exclusion criteria:
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
Biological: Erenumab
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
Biological: Erenumab
Two pre-filled syringes containing placebo identical in appearance to erenumab
Other: Placebo
70 mg/mL pre-filled syringe administered subcutaneously
Also known as: AMG334
Matching placebo in pre-filled syringe administered subcutaneously
Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Time frame: Baseline up to Month 3
Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3
Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
Time frame: Baseline and at Month 3
Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3
Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.
Time frame: Baseline up to Month 3
Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3
The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme
Time frame: Baseline up to Month 3
| Milestone | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Started | 338 | 224 | 338 |
| Full analysis set | 329 | 219 | 330 |
| Safety analysis set | 335 | 224 | 335 |
| Completed | 321 | 218 | 326 |
| Not completed | 17 | 6 | 12 |
| Withdrew: Adverse event | 0 | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Physician decision | 4 | 0 | 1 |
| Withdrew: Pregnancy | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 9 | 6 | 5 |
| Withdrew: Randomized but not treated | 3 | 0 | 3 |
| Milestone | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Started | 324 | 218 | 328 |
| Completed | 311 | 214 | 315 |
| Not completed | 13 | 4 | 13 |
| Withdrew: Lost to follow-up | 6 | 2 | 1 |
| Withdrew: Withdrawal by subject | 7 | 2 | 12 |
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
| Migraine days/month | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) | -4.20 ± 0.25 | -4.79 ± 0.30 | -3.10 ± 0.25 |
Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity 2. ≥ 1 of the following associated symptoms: nausea and/or vomiting, photophobia and phonophobia
| percentage of participants | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3 | 55.3 | 63.9 | 44.8 |
Number of days on which acute migraine-specific medications were used were recorded in eDiary between each monthly IP dose. Migraine-Specific medications include two categories of medications: triptan-based migraine medications and ergotamine-based migraine medications. Monthly migraine-specific medication use at baseline is the number of migraine-specific medication treatment days in the baseline period.
| Migraine days/month | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3 | -1.84 ± 0.26 | -2.39 ± 0.33 | -0.49 ± 0.26 |
The HIT-6 is a short-form self-administered questionnaire based on the internet-HIT question pool. The HIT-6 was developed as a global measure of adverse headache impact to assess headache severity in the previous month and change in a patient's clinical status over a short period of time. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social). Each of the 6 questions is responded to using 1 of 5 response categories: "never," "rarely," "sometimes," "very often," or "always." For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points were summed to produce a total HIT-6 score that ranges from 36 to 78. Scores were categorized into 4 grades, representing little or no impact (49 or less), some impact (50-55), substantial impact (56-59), and severe impact (60-78) due to headache. Lower values represent better outcomes, therefore negative change denotes improveme
| scores on a scale | AMG334 70 mg | AMG334 140 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3 | -8.39 ± 0.45 | -9.34 ± 0.54 | -6.62 ± 0.44 |
Collected over Adverse events were reported from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 28 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AMG 334 70mg | 0/335 (0%) | 10/335 (3%) | 83/335 (24.8%) |
| AMG 334 140mg | 0/224 (0%) | 0/224 (0%) | 58/224 (25.9%) |
| Placebo | 0/335 (0%) | 5/335 (1.5%) | 85/335 (25.4%) |
| Event | AMG 334 70mg | AMG 334 140mg | Placebo |
|---|---|---|---|
| MigraineNervous system disorders | 2/335 | 0/224 | 1/335 |
| AbortionPregnancy, puerperium and perinatal conditions | 0/335 | 0/224 | 2/335 |
| Epigastric discomfortGastrointestinal disorders | 1/335 | 0/224 | 0/335 |
| AstheniaGeneral disorders | 1/335 | 0/224 | 0/335 |
| Cellulitis orbitalInfections and infestations | 0/335 | 0/224 | 1/335 |
| GastroenteritisInfections and infestations | 1/335 | 0/224 | 1/335 |
| LabyrinthitisInfections and infestations | 1/335 | 0/224 | 0/335 |
| Viral infectionInfections and infestations | 0/335 | 0/224 | 1/335 |
| Cerebral infarctionNervous system disorders | 1/335 | 0/224 | 0/335 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/335 | 0/224 | 0/335 |
| Event | AMG 334 70mg | AMG 334 140mg | Placebo |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 20/335 | 12/224 | 10/335 |
| PyrexiaGeneral disorders | 11/335 | 5/224 | 19/335 |
| NasopharyngitisInfections and infestations | 2/335 | 9/224 | 13/335 |
| Upper respiratory tract infectionInfections and infestations | 13/335 | 6/224 | 9/335 |
| DizzinessNervous system disorders | 4/335 | 7/224 | 6/335 |
| Injection site erythemaGeneral disorders | 4/335 | 1/224 | 8/335 |
| InfluenzaInfections and infestations | 8/335 | 3/224 | 5/335 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/335 | 5/224 | 4/335 |
| DiarrhoeaGastrointestinal disorders | 5/335 | 2/224 | 6/335 |
| NauseaGastrointestinal disorders | 3/335 | 2/224 | 6/335 |
| Age, Continuous(years) | AMG334 70 mg | AMG334 140 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 37.3 ± 10.0 | 37.1 ± 9.6 | 38.0 ± 10.1 | 37.5 ± 9.9 |
| Sex: Female, Male(Participants) | AMG334 70 mg | AMG334 140 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 272 | 184 | 281 | 737 |
| Male | 66 | 40 | 57 | 163 |
| Race/Ethnicity, Customized(participants) | AMG334 70 mg | AMG334 140 mg | Placebo | Total |
|---|---|---|---|---|
| White | 58 | 35 | 60 | 153 |
| Black or African American | 1 | 0 | 0 | 1 |
| Asian | 278 | 184 | 269 | 731 |
| American Indian or Alaska Native | 1 | 0 | 1 | 2 |
| Multiple | 9 | 8 | 5 | 22 |
| Other | 9 | 13 | 13 | 35 |
| Monthly Migraine Days at Baseline(Migraine days/month) | AMG334 70 mg | AMG334 140 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 8.09 ± 2.62 | 8.27 ± 3.14 | 8.35 ± 2.76 | 8.23 ± 2.81 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Feb 2018 to primary completion in Jan 2020, 23 months.
Results were first posted in Mar 2021, 1 year 1 month after primary completion.
Of 21 industry-sponsored phase 3 interventional studies under Headache, half reached primary completion within 17 months of starting (the median); a quarter within 13 and three quarters within 31. This study's 23 months is above that.
Counting every sponsor, half of 30 studies reached it within 18 months; a quarter within 13 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erenumab