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An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALD403 (Eptinezumab) Dose Level 1 | Experimental | ALD403 (Eptinezumab) Dose Level 1 (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALD403 (Eptinezumab) | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) | Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion. | 104 Weeks |
| Number of Participants With a Clinically Significant Electrocardiogram | Overall investigator interpretation of participant electrocardiogram | Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104 |
| Number of Participants With Any Clinically Significant Laboratory Values | Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database. | 104 Weeks |
| Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits. | 104 Weeks |
| Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator | 104 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change (PGIC) at Week 104 | The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. | Week 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | 92108 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41996064 | Derived | Starling AJ, Kudrow D, Kapur N, Awad SF, Grossman SW, Patel F, Ailani J, Blumenfeld A, Lipton RB. Long-Term Reductions in Headache Frequency, Severity, and Disability with Eptinezumab in Adults with Chronic Migraine: Results from the PREVAIL Trial. Pain Ther. 2026 Jun;15(3):785-801. doi: 10.1007/s40122-026-00831-0. Epub 2026 Apr 17. | |
| 35804294 |
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A total of 158 participants signed the ICF, of which 128 participants met the entry criteria and were randomized into the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg ALD403 | Participants were enrolled and scheduled to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2018 | Mar 19, 2020 |
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| Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement. | Baseline to Week 12 |
| Health Related Quality of Life (EQ-5D-5L) at Week 12 | The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. | Week 12 |
| Change in Baseline of Headache Impact Test (HIT-6) Score | The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores. | Baseline, Week 1-4, Week 9-12 |
| Change in Most Bothersome Symptom at Week 48 | The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale. | Baseline to Week 48 |
| Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score | The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability: 0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability; A higher value represents a worse outcome. | Baseline to Week 12 |
| Development of Anti-ALD403 Antibody by Visit | Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months. | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 |
| Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity. | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 |
| Santa Monica |
| California |
| 90404 |
| United States |
| Research Site | Colorado Springs | Colorado | 80918 | United States |
| Research Site | Bradenton | Florida | 34201 | United States |
| Research Site | DeLand | Florida | 32720 | United States |
| Massachusetts | Miami | Florida | 33125 | United States |
| Research Site | Tampa | Florida | 33634 | United States |
| Research Site | Winter Haven | Florida | 33880 | United States |
| Research Site | Prairie Village | Kansas | 66206 | United States |
| Massachusetts | Boston | Massachusetts | 02131 | United States |
| Research Site | North Attleboro | Massachusetts | 02760 | United States |
| 02481 | Wellesley | Massachusetts | 02481 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Brooklyn | New York | 11229 | United States |
| Research Site | Rochester | New York | 14609 | United States |
| Research Site | Dayton | Ohio | 45432 | United States |
| Research Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Research Site | Chattanooga | Tennessee | 37421 | United States |
| Research Site | Fort Worth | Texas | 76104 | United States |
| Research Site | Bellevue | Washington | 98007 | United States |
| Blumenfeld A, Ettrup A, Hirman J, Ebert B, Cady R. Long-term reductions in disease impact in patients with chronic migraine following preventive treatment with eptinezumab. BMC Neurol. 2022 Jul 8;22(1):251. doi: 10.1186/s12883-022-02774-3. |
| 33781209 | Derived | Smith TR, Spierings ELH, Cady R, Hirman J, Schaeffler B, Shen V, Sperling B, Brevig T, Josiassen MK, Brunner E, Honeywell L, Mehta L. Safety and tolerability of eptinezumab in patients with migraine: a pooled analysis of 5 clinical trials. J Headache Pain. 2021 Mar 30;22(1):16. doi: 10.1186/s10194-021-01227-5. |
| 33740902 | Derived | Kudrow D, Cady RK, Allan B, Pederson SM, Hirman J, Mehta LR, Schaeffler BA. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021 Mar 19;21(1):126. doi: 10.1186/s12883-021-02123-w. |
| Participants Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population includes all participants who received study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg ALD403 | Participants were randomized to receive 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Duration of migraine diagnosis at baseline | Mean | Standard Deviation | years |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Treatment Emergent Adverse Events (TEAEs) | Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion. | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | 104 Weeks |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With a Clinically Significant Electrocardiogram | Overall investigator interpretation of participant electrocardiogram | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104 |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Any Clinically Significant Laboratory Values | Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database. | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | 104 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits. | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | 104 Weeks |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs | Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | 104 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Change (PGIC) at Week 104 | The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse. | Safety Population includes all participants who received study drug. Only participants who completed the Week 104 Visit are included | Posted | Count of Participants | Participants | Week 104 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores | The SF-36 is a health survey consisting of 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks (scale range: 0=worst to 100=best). Increases from baseline indicate improvement. | Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Health Related Quality of Life (EQ-5D-5L) at Week 12 | The EQ-5D-5L is a descriptive health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension. | Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included | Posted | Count of Participants | Participants | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change in Baseline of Headache Impact Test (HIT-6) Score | The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assess over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact). The change in baseline will be calculated from the average scores. | Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 1-4, Week 9-12 |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Most Bothersome Symptom at Week 48 | The Investigator verbally obtained the most bothersome symptom associated with the participant's migraine during the screening visit. The most bothersome symptom may include nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, or other migraine related symptoms. Participants were asked to rate the improvement in this symptom from screening on a seven-point scale. | Safety Population includes all participants who received study drug. Only participants who completed the Week 48 Visit are included | Posted | Count of Participants | Participants | Baseline to Week 48 |
|
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| Secondary | Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score | The MIDAS questionnaire measures the effect headaches have on the participant's daily functioning. MIDAS is composed of five questions that ask about the participant's performance over the past 3 months. The response to each question is provided in number of days which are summed to determine the MIDAS total score and level of disability: 0-5, MIDAS Grade I, little or no disability; 6-10, MIDAS Grade II, mild disability; 11-20, MIDAS Grade III, moderate disability; 21+, MIDAS Grade IV, severe disability; A higher value represents a worse outcome. | Safety Population includes all participants who received study drug. Only participants who completed the Week 12 Visit are included | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
|
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| Secondary | Development of Anti-ALD403 Antibody by Visit | Serum blood samples were taken at visits to test for the development of antibodies to ALD403, or anti-drug antibodies (ADA). Participants who tested positive for anti-ALD403 antibodies at the time of the last study visit were asked to provide up to 2 additional blood samples for immunogenicity testing at approximately 3 month intervals for up to 6 months. | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 |
|
| |||||||||||||||||||||||||||
| Secondary | Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit | Any samples that were positive for anti-ALD403 antibody, there was additional testing to characterize the anti-ALD403 antibody for the potential to neutralize (NAb) ALD403 activity. | Safety Population includes all participants who received study drug. | Posted | Count of Participants | Participants | Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104 |
|
|
Baseline to Week 104 (end of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 mg ALD403 | Participants received 4 ALD403 IV infusions on Day 0, 84 (Week 12), 168 (Week 24), and 252 (Week 36), then up to 4 additional infusions at Weeks 48, 60, 72 and 84. | 0 | 128 | 5 | 128 | 49 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic Reaction | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Diabetes Mellitus Inadequate Control | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
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| Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Conversion Disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@Lundbeck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | Mar 19, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000628361 | eptinezumab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Extreme problems |
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| Severe problems |
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| Extreme problems |
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| Severe problems |
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| Extreme problems |
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| Severe problems |
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| Extreme problems |
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