Trial · NCT04857671
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in TTH-headache days in week 5-8 of the active period versus the placebo period. | 36 weeks | Difference in TTH- headache days in week 5-8 of the active period versus the placebo period. |
| Secondary | 50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12 | 36 weeks | 50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12 |
| Secondary | Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period | 36 weeks | Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period |
| Secondary | 30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12 | 36 weeks | 30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12 |
| Secondary | Quality of life score on EQ-5D-5L | 36 weeks | EQ-5D-5L at week 8 and 12 after injection |
| Secondary | Patient Global Impression of Improvement (PGI-I) | 36 weeks | scale 7-points - (very much better) to 7 (very much worse) 8 and 12 after injection |
| Secondary | Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12 | 36 weeks | NRS scale: 0 meaning no pain and 10 meaning the worst pain imaginable) |
| Secondary | Headache Impact Test (HIT-6) | 36 weeks | HIT-6 at week 8 and 12 after injection |
| Secondary | Average number of headache hours per day in week 1-4, 5-8 and 9-12. | 36 weeks | Average number of headache hours per day in week 1-4, 5-8 and 9-12. |
| Secondary | Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12 | 36 weeks | Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12 |
| Secondary | Acceptability | 36 weeks | Acceptability |
| Secondary | Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period | 36 weeks | Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period |
| Other | e the efficacy of BoNT in treatment group as compared to placebo group in reducing the area-under-the-headache curve (AUC) | recorded daily as ePROMs in an eDiary throughout the study participation. | Tertiary/Exploratory objective and endpoints Exploratory objective: To investigate the efficacy of BoNT in treatment group as compared to placebo group in reducing the area-under-the-headache curve (AUC). This variable defined according to IHS-guidelines(22) Exploratory endpoint: To investigate the efficacy of BoNT in treatment group as compared to placebo group in reducing the area-under-the-headache curve (AUC). The area-under-the-headache curve (AUC) is validated and recommended by the International Headache Society for controlled trials of preventive treatment of TTH in adults . The AUC measurement combines headache intensity and headache duration, and it will provide more insights to how the burden of headache has changed after the intervention than the primary efficacy measures (days with TTH). AUC is defined accordingly as the sum of the daily recordings of the headache duration multiplied with the headache intensity (also called headache index). |
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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