Trial · NCT05064397
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 | 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). |
| Secondary | Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | |
| Secondary | Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | |
| Secondary | Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks | Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40 | |
| Secondary | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks) | Week 1 to Week 48 | Participants counted as being in remission if they had no cluster headache attacks for at least 1 month. |
| Secondary | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion) | Week 1 to Week 12 | |
| Secondary | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion) | Week 13 to Week 24 | |
| Secondary | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion) | Week 25 to Week 36 | |
| Secondary | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion) | Week 37 to Week 48 | |
| Secondary | Number of Participants Who Received a Transitional Therapy During the Treatment Period | Week 1 to Week 48 | Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids. |
| Secondary | Patient Global Impression of Change (PGIC) Score | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status. |
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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