Trial · NCT04857671
Botulinum Toxin A in Frequent and Chronic Tension-type Headache
NCT04857671, Phase 3, Completed, Helse Nord-Trøndelag HF
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Botulinum Toxin A in Frequent and Chronic Tension-type Headache. Trials, record NCT04857671. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04857671
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Botulinum Toxin A in Frequent and Chronic Tension-type Headache
- NCT number
- NCT04857671
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 66 participants, actual
- Lead sponsor
- Helse Nord-Trøndelag HF
- Conditions
- Tension-Type Headache
- Interventions
- Botulinum Toxin Type A in saline water, Isotone saline water
- First posted
- 2021-04-23
- Last updated
- 2025-03-13
- Other registries' IDs
- eudract:2019-001385-16
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04857671
GET https://conductscience.org/api/trials/v1/NCT04857671/registered