Trial · NCT04970355
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Other | Change from baseline in HIT-6 quality of life at week 6 (day 42). Difference between erenumab and placebo scores at week 6 and improvement of HIT-6 scores from baseline. | Baseline; Week 6 | This information will allow to assess the impact of attacks on headache related disability. The recall period for 3 questions is 4weeks \& the remaining questions do not have a specific recall period. |
| Other | Change from baseline in average duration in minutes of recorded CH attacks over the last 2 weeks (days 29-42) of the double-blind epoch. | Baseline: Weeks 5-6 | Duration of CH 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. |
| Other | Change from baseline in frequency of acute medication per week averaged over week 5 and 6 (days 29-42). | Baseline: Weeks 5-6 | Baseline data and the mean change from baseline in the overall weekly average number of days with the use of cluster-specific acute headache medications (as liosted in the protocoll) during weeks 5-6 after administration of the first dose of study drug (based on Week 0 to 5-6 data) is reported. |
| Other | Change from baseline in average intensity in average numerical pain rating scale value of recorded attacks over week 5 and 6 (days 29-42). | Baseline: Weeks 5-6 | Participants marked the level of CH-associated pain using the numerical pain ratiung scale. |
| Other | Discontinuation of treatment due to all-cause during the double-blind epoch of the study | Weeks 1-8 | Rate of patients discontinuing treatment due to any cause during the double-blind treatment period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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