A Phase 4 interventional study of Erenumab in Migraine, Migraine Disorders and Migraine Headache, sponsored by Novartis Pharmaceuticals. Completed at 75 sites in Germany. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Prevention
This is a 128-week open-label study to assess the long-term safety and tolerabilty of the monoclonal antibody erenumab in migraine patients.
This was an open-label, multi-center, single arm study with flexible dosing allowing both dose adjustment and one drug holiday per patient.
The study design consisted of 3 parts:
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 701 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consisted of patients with a documented history of episodic (4 - 14 baseline migraine days) or chronic migraine (≥15 baseline headache days), who had been successfully randomized to clinical trial CAMG334ADE01.
Key inclusion Criteria:
Key exclusion Criteria:
Erenumab dose could be adjusted from 70 mg to 140 mg or vice versa at the discretion of the physician at any scheduled study visit.
Biological: Erenumab
Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Also known as: AMG334; Aimovig
Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years
This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.
Time frame: Up to 128 weeks
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE
Participants discontinuing the Open-label Treatment Epoch due to adverse events (AEs) to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
Time frame: Up to 128 weeks
Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons
Participants discontinuing the Open-label Treatment Epoch due to non-AE reasons to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
Time frame: Up to 128 weeks
Participants took part in 79 investigative sites in Germany.
| Milestone | Erenumab |
|---|---|
| Started | 701 |
| Completed | 534 |
| Not completed | 167 |
| Withdrew: Subject/guardian decision | 91 |
| Withdrew: Adverse event | 24 |
| Withdrew: Lost to follow-up | 19 |
| Withdrew: New therapy for study indication | 9 |
| Withdrew: Pregnancy | 9 |
| Withdrew: Withdrawal of informed consent | 8 |
| Withdrew: Physician decision | 4 |
| Withdrew: Protocol deviation | 3 |
This outcome measure was calculated dividing the number of adverse events (AEs) by the total patient exposure time and standardizing it per 100 patient-years. Exact Pearson-Clopper confidence intervals for single proportions were calculated to evaluate the precision of the estimated parameter.
| number of AEs per 100 patient-years | Erenumab |
|---|---|
| Exposure Adjusted Incidence Rate of AE During Open-label Treatment Epoch Per 100 Subject Years | 101.71 (92.28 to 111.14) |
Participants discontinuing the Open-label Treatment Epoch due to adverse events (AEs) to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
| Participants | Erenumab |
|---|---|
| Proportion of Patients Discontinuing Open-label Treatment Epoch Due to AE | 29 |
Participants discontinuing the Open-label Treatment Epoch due to non-AE reasons to evaluate the long-term tolerability of erenumab in patients with episodic migraine or chronic migraine.
| Participants | Erenumab |
|---|---|
| Proportion of Patients Discontinuing Open-label Treatment Epoch Due to Non-AE Reasons | 126 |
Collected over From first dose of study treatment in the Open-label Treatment Epoch of this study to 8 weeks after last dose (up to 132 weeks).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Erenumab | 0/701 (0%) | 86/701 (12.3%) | 514/701 (73.3%) |
| Event | Erenumab |
|---|---|
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | 7/701 |
| DepressionPsychiatric disorders | 5/701 |
| AppendicitisInfections and infestations | 4/701 |
| Back painMusculoskeletal and connective tissue disorders | 4/701 |
| TachycardiaCardiac disorders | 2/701 |
| VertigoEar and labyrinth disorders | 2/701 |
| CholelithiasisHepatobiliary disorders | 2/701 |
| Arthropod stingInjury, poisoning and procedural complications | 2/701 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/701 |
| MigraineNervous system disorders | 2/701 |
| Event | Erenumab |
|---|---|
| COVID-19Infections and infestations | 242/701 |
| NasopharyngitisInfections and infestations | 134/701 |
| ConstipationGastrointestinal disorders | 103/701 |
| FatigueGeneral disorders | 61/701 |
| HypertensionVascular disorders | 46/701 |
| Immunisation reactionInjury, poisoning and procedural complications | 43/701 |
| MigraineNervous system disorders | 43/701 |
| Back painMusculoskeletal and connective tissue disorders | 42/701 |
| HeadacheNervous system disorders | 42/701 |
| DepressionPsychiatric disorders | 39/701 |
| Age, Continuous(years) | Erenumab |
|---|---|
| Mean | 41.8 ± 12.3 |
| Sex: Female, Male(Participants) | Erenumab |
|---|---|
| Female | 608 |
| Male | 93 |
| Race/Ethnicity, Customized(Participants) | Erenumab |
|---|---|
| White | 695 |
| Asian | 1 |
| Unknown | 1 |
| Other | 4 |
Documents are hosted by the registry — open the source record to download them.
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
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