Trial · NCT05064397
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| 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 |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks) | Week 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Received a Transitional Therapy During the Treatment Period | Week 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Patient Global Impression of Change (PGIC) Score | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 | 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 |
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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