Trial · NCT05546320
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder rate | Baseline to 12 weeks post-randomization | Defined as the proportion of participants achieving a ≥50% reduction in the mean number of monthly migraine days or migraine attacks at 12 weeks post-randomization compared to baseline. |
| Secondary | Change in monthly migraine days | Baseline to 12 weeks post-randomization | Change in the mean number of migraine days at 12 weeks post-randomization compared to baseline. |
| Secondary | Change in monthly migraine attacks | Baseline to 12 weeks post-randomization | Change in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline. |
| Secondary | Reduction rate of migraine days | Baseline to 12 weeks post-randomization | Percentage reduction in the mean number of migraine days at 12 weeks post-randomization compared to baseline. |
| Secondary | Reduction rate of migraine attacks | Baseline to 12 weeks post-randomization | Percentage reduction in the mean number of migraine attacks at 12 weeks post-randomization compared to baseline. |
| Secondary | Complete migraine cessation | Weeks 9-12 post-randomization | Percentage of participants achieving complete migraine cessation during the 12-week treatment period. |
| Secondary | Migraine-specific quality of life (MSQ v2.1) | Baseline to 12 weeks post-randomization | Change in Migraine-Specific Quality of Life Questionnaire (MSQ version 2.1) scores at 12 weeks post-randomization compared to baseline. |
| Other | Safety Outcome Measures - Any adverse events | Baseline to 12 weeks post-randomization | Any undesirable medical condition occurring in a participant after initiation of the investigational medicinal products, regardless of its causal relationship with the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Adverse events related to investigational medicinal products | Baseline to 12 weeks post-randomization | Adverse events assessed by investigators as having a definite, probable, or possible causal relationship with the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Serious adverse events | Baseline to 12 weeks post-randomization | Events including death, life-threatening events, hospitalization or prolongation of hospitalization, permanent disability or damage, congenital anomaly or birth defect, or other medically significant events, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Serious adverse events related to investigational medicinal products | Baseline to 12 weeks post-randomization | Serious adverse events assessed by investigators as having a definite, probable, or possible causal relationship with the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Any bleeding events | Baseline to 12 weeks post-randomization | Bleeding events classified according to the Bleeding Academic Research Consortium criteria (types 1 to 5), assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Major bleeding events | Baseline to 12 weeks post-randomization | Bleeding events classified as Bleeding Academic Research Consortium type 3b, type 3c, or type 5, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Gastrointestinal symptoms | Baseline to 12 weeks post-randomization | Any discomfort or symptoms involving the gastrointestinal tract occurring after administration of the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Bradycardia | Baseline to 12 weeks post-randomization | Symptomatic reduction in heart rate occurring after administration of the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
| Other | Safety Outcome Measures - Hypotension | Baseline to 12 weeks post-randomization | Symptomatic reduction in blood pressure occurring after administration of the investigational medicinal products, assessed by investigators and adjudicated by the clinical event committee. |
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/NCT05546320/registered