Trial · NCT04970355
Efficacy of Erenumab in Chronic Cluster Headache
NCT04970355, Phase 2, Completed, Charite University, Berlin, Germany
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Erenumab in Chronic Cluster Headache. Trials, record NCT04970355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04970355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Erenumab in Chronic Cluster Headache
- NCT number
- NCT04970355
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Charite University, Berlin, Germany
- Conditions
- Cluster Headache, Trigeminal Autonomic Cephalalgias, Headache Disorders, Primary, Brain Disease
- Interventions
- Erenumab, Placebo
- First posted
- 2021-07-21
- Last updated
- 2024-01-23
- Other registries' IDs
- eudract:2020-004399-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of weekly cluster headache attack frequency from baseline over the last 2 weeks of the double-blind epoch (averaged for 7 days). | Baseline; Weeks 5-6 (Days 29-42) | Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 6 weeks of daily data during double-blind treatment phase will be converted into 7-calendar day intervals: The baseline 7-10 day interval, Week 5+6. |
| Secondary | Percentage of participants with a 50% or greater reduction from baseline in the weekly number of cluster headache attacks averaged per 7 days over the last 2 weeks of the DB epoch. | Baseline; Weeks 5-6 (Days 29-42) | A 50% responder is any participant who has a ≥50% reduction from baseline in the weekly number of cluster headache attacks in a 7-day interval: Weeks 5+6 |
| Secondary | Patient Global Impression of Improvement (PGI-I) at week 6. | Baseline; Week 6 | PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. |
| Other | Reduction from baseline in the weekly number of CH attacks in each of the last 2 weeks of the double blind epoch. | Baseline, Week 5; Week 6 | Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 6 weeks of daily data during double-blind treatment phase will be converted into 7-calendar day intervals: The baseline 7-10 day interval, week 5 and week 6. |
| Other | Reduction from baseline in the number of weekly CH attacks over the entire double-blind trial period (day 1-42). | Baseline, Weeks 1- 6 | Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 6 weeks of daily data during double-blind treatment phase will be converted into 7-calendar day intervals: The baseline 7-10 day interval; week 1-week 6 |
| Other | Safety and tolerability of erenumab/placebo | Baseline; Week 1-Week 10 | Number of AEs, TEAEs, SAEs, and number of patients discontinue study participation stratified for treatment and non-treatment related discontinuation. |
| Other | Discontinuation of the study due to intolerable attack frequency or severity during the double-blind epoch of the study. | Baseline; Week 1-Week 6 | To compare erenumab with placebo in reduction of frequency and intensity of CH attacks assessed by the rate of patients discontinuing the study due to intolerable attack frequency or severity. |
| Other | Number of patients achieving at least a 30% reduction from baseline in weekly CH attacks averaged over the last 2 weeks (days 29-42) of the double-blind epoch | Baseline, Week 5-Week 6 | A 30% responder is any participant who has a ≥30% reduction from baseline in the weekly number of cluster headache attacks in a 7-day interva in Weeks 5+6 |
| Other | Number of patients achieving at least a 70 % reduction from baseline in weekly CH attacks averaged over the last 2 weeks (days 29-42) of the double-blind epoch. | Baseline, Week 5-Week 6 | A 70% responder is any participant who has a ≥70% reduction from baseline in the weekly number of cluster headache attacks in a 7-day interval: Weeks 5+6 |
| Other | Change from baseline in SF-12 quality of life at week 6 (day 42). Difference between erenumab and placebo scores at week 6 | Baseline; Week 6 | This information will help keep track of how participants feel and how well they are able to do usual activities. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40526384 | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04970355
GET https://conductscience.org/api/trials/v1/NCT04970355/registered