Trial · NCT04688775
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response. |
| Secondary | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | |
| Secondary | Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | Abortive medications included the use of triptans or oxygen (O2). |
| Secondary | Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3 | Baseline (Week 0), Days 1-3 | |
| Secondary | Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | |
| Secondary | Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks | From first infusion (Baseline, Day 0) to 4 weeks | Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution. |
| Secondary | Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP | From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period | |
| Secondary | Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3 | Baseline (Week 0), Days 1-3 | The severity of pain 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). |
| Secondary | Change From Baseline to Week 1 in the Number of Weekly Attacks | Baseline (Week 0), Week 1 | |
| Secondary | Change From Baseline to Week 2 in the Number of Weekly Attacks | Baseline (Week 0), Week 2 | |
| Secondary | Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1 | Baseline (Week 0), Week 1 | |
| Secondary | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1 | Baseline (Week 0), Week 1 | |
| Secondary | Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | |
| Secondary | Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2 | Baseline (Week 0), Weeks 1-2 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Secondary | Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain | Baseline (Week 0), Week 1 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Secondary | Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain | Baseline (Week 0), Week 2 | The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Secondary | Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4 | Baseline (Week 0), Weeks 1-4 | |
| Secondary | Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4 | Baseline (Week 0), Weeks 1-4 | The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes. |
| Secondary | Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4 | Baseline (Week 0), Weeks 1, 2, 3, and 4 | 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). |
| Secondary | Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4 | Baseline (Week 0), Weeks 3-4 |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT04688775/registered