Trial · NCT05064397
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
NCT05064397, Phase 3, Completed, H. Lundbeck A/S; results first posted 2024-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH). Trials, record NCT05064397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05064397
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
- NCT number
- NCT05064397
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 131 participants, actual
- Lead sponsor
- H. Lundbeck A/S
- Conditions
- Chronic Cluster Headache
- Interventions
- Eptinezumab
- First posted
- 2021-10-01
- Last updated
- 2024-08-06
- Results first posted
- 2024-08-06
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (AEs) | From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 | A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
| Secondary | Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks) | Week 1 to Week 48 | Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months. |
| Secondary | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack. |
| Secondary | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | |
| Secondary | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | |
| Secondary | Change From Baseline in the Average Number of Weekly Attacks | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks. |
| Secondary | Change From Baseline in the Number of Weekly Attacks | Baseline (Week 0), Weeks 1-4 | The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown. |
| Secondary | Change From Baseline in the Number of Weekly Attacks | Baseline (Week 0), Weeks 1-2 | The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown. |
| Secondary | Change From Baseline in the Number of Monthly Attacks | Baseline (Week 0), Months 1-12 | The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown. |
| Secondary | Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (AEs) | From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 | The APTS included all participants who received infusion with eptinezumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks) | Week 1 to Week 48 | The Full Analysis Set (FAS) included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point. | Abortive therapy use per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point. | Oxygen use per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point. | Triptans use per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Average Number of Weekly Attacks | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point. | Attacks per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Number of Weekly Attacks | Baseline (Week 0), Weeks 1-4 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | Attacks per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Number of Weekly Attacks | Baseline (Week 0), Weeks 1-2 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | Attacks per week | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Number of Monthly Attacks | Baseline (Week 0), Months 1-12 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure. | Attacks per month | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | The FAS included all participants in the APTS who had a valid assessment of the baseline number of weekly attacks and a post-baseline assessment of the number of weekly attacks. Here, Overall Number of Participants Analyzed is the number of participants evaluable for this outcome measure, and Number analyzed is the number of participants evaluable at each specified time point. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group370
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) | Eptinezumab | 106 | Participants | ||
| Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks) | Eptinezumab | 7 | Participants | ||
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 1 | -3.63 | Standard Error 0.53 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 2 | -4.24 | Standard Error 0.70 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 3 | -4.90 | Standard Error 0.76 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 4 | -4.99 | Standard Error 0.94 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 13 | -7.22 | Standard Error 0.84 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 14 | -6.83 | Standard Error 0.85 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 15 | -6.06 | Standard Error 0.84 | Abortive therapy use per week |
| Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used | Eptinezumab | Week 16 | -6.42 | Standard Error 0.96 | Abortive therapy use per week |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eptinezumab | 131 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Eptinezumab | 131 | |
| Overall Study | COMPLETED | Eptinezumab | 108 | |
| Overall Study | NOT COMPLETED | Eptinezumab | 23 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrioventricular block first degree | Cardiac disorders | Eptinezumab | 3 | 131 | 5 |
| other | Tinnitus | Ear and labyrinth disorders | Eptinezumab | 4 | 131 | 4 |
| other | Abdominal pain upper | Gastrointestinal disorders | Eptinezumab | 4 | 131 | 6 |
| other | Constipation | Gastrointestinal disorders | Eptinezumab | 6 | 131 | 9 |
| other | Nausea | Gastrointestinal disorders | Eptinezumab | 8 | 131 | 8 |
| other | Vomiting | Gastrointestinal disorders | Eptinezumab | 7 | 131 | 7 |
| other | Asthenia | General disorders | Eptinezumab | 6 | 131 | 11 |
| other | Fatigue | General disorders | Eptinezumab | 22 | 131 | 30 |
| other | Influenza like illness | General disorders | Eptinezumab | 3 | 131 | 4 |
| other | Oedema peripheral | General disorders | Eptinezumab | 5 | 131 | 7 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eptinezumab | 0 | 131 |
| Total, other adverse events | Eptinezumab | 96 | 131 |
| Total, serious adverse events | Eptinezumab | 11 | 131 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40252664 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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