Botulinum Toxin A in Frequent and Chronic Tension-type Headache (NCT04857671) | Clinical Trial Compass
CompletedPhase 3
Botulinum Toxin A in Frequent and Chronic Tension-type Headache
Norway66 participantsStarted 2022-10-03
Plain-language summary
Chronic tension-type headache (CTTH) is an underestimated disabling condition that affects a large number of patients. The treatment options for both episodic tension-type headaches, but especially CTTH are few. Poor long-term effects of existing treatment for CTTH (Sarotex, SSRIs, physiotherapy) are reported. Patients with CTTH also have a high risk of developing drug overdose headache (MOH). Non-drug treatments with physiotherapy or alternative medicine also show poor long-term effects. Literature reviews show that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A, but larger controlled trials are needed to confirm or deny this.
The investigators will study effect of treatment with botulinum toxin A in CTTH in BACT study, and will include participants with both frequent and chronic TTH with 10 or more headache days per month.
If BACT outcomes are positive, this will open a possibility for a new treatment for TTH patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
Eligible participants must meet all of the inclusion criteria in this study.
* Aged 18 to 75 years
* Frequent or chronical tension type headache according to the ICHD-3 (2.2.3) criteria with 10 or more headache days per month
* Headache history of minimum one year.
* Previously unsatisfactory treatment effect, bothersome side-effects to or contra-indications to at least one TTH prophylactic drug.
* Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period.
* In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception (for more details below).
* Signed informed consent.
Exclusion criteria
All candidates meeting any of the exclusion criteria at baseline or visit nr.2 will be excluded from study participation:
* Patients with migraine with more than 1 migraine day per month.
* Patients with other forms of primary or secondary headaches; including medication overuse headache (MOH).
* Change in type, dosage or dose frequency of preventive headache medication \< 1 months prior to inclusion.
* Previous exposure at any time to any botulinum toxin serotype.
* Pregnancy, breastfeeding or planned pregnancy.
* Patients with diseases that are contraindications for use of BoNT-A (Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, other diseases interfering with neuromuscular function) or allergy to BoNT-A, or trea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.