Tension-Type HeadachePhase 3BACTNCT04857671
Botulinum Toxin A in Frequent and Chronic Tension-type Headache
A Phase 3 study testing Botulinum Toxin Type A in saline water and Isotone saline water in people with Tension-Type Headache, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Botulinum Toxin Type A in saline water and Isotone saline water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteNorway
- Study dates
- 3 Oct 2022to 4 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 treatment with drugs affecting the neuromuscular junction;
- Active infection at the sites of injection
- Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months.
- Any psychiatric disorder that may affect ability to comply with study procedures in the opinion of study investigator.
- Other severe chronical pain conditions.
- Abuse of alcohol or illicit drugs.
- Participating in another trial that might affect the current study.
- Contraception for women of childbearing potential (WOCBP) Such methods will include combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence. This group of patients should not be using other drugs that might interact and reduce the efficacy of the used anticonceptive drug. WOCBP is defined as fertile women, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods, include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Ability to understand study procedures and to comply with them for the entire length of the study. WOCBP will have to agree to take a pregnancy test before the injection with the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BACT - Botulinum Toxin A in Frequent and Chronic Tension-type Headache With the FollowTheSutures Paradigm. A Double Blind, Randomized, Placebo-controlled Cross-over Trial
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.
Read the detailed description
BACT studies the efficacy of treatment with botulinum toxin with a follwthestuture injection regime in frequent and chronic tension type headache (TTH). This is be a randomized, placebo-controlled, triple blind, cross-over trial. The primary efficacy variable is the difference in monthly headache days in the active period versus the placebo period. In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. The target population is male and female patients 18 to 75 years of age with TTH, with 10 or more headache days per month.
- Conditions
- Tension-Type Headache
- Being tested
- Botulinum Toxin Type A in saline water, Isotone saline water
- Keywords
- Botulinum toxins, type A, Injections
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A in saline waterDrug
Also called Botox
100 Allergan units Botulinum toxin A in a total of 2 ml sodium chloride (NaCl) 0,9% Braun.
5 IU of Botox per injection point (0,1ml); in total 100 IU per 20 injections points.
Isotone saline waterDrug
Also called Sodium chloride solution, NaCl solution
2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin A injections | Experimental | Botulinum toxin A (Botox) Receives: Drug: Botulinum Toxin Type A in saline water; Drug: Isotone saline water |
| placebo injections | Placebo comparator | Isotone saline water Receives: Drug: Botulinum Toxin Type A in saline water; Drug: Isotone saline water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.
Difference in TTH- headache days in week 5-8 of the active period versus the placebo period.
Measured: 36 weeks
Secondary outcomes (11)
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Measured: 36 weeks
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Measured: 36 weeks
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Measured: 36 weeks
Quality of life score on EQ-5D-5L
EQ-5D-5L at week 8 and 12 after injection
Measured: 36 weeks
Patient Global Impression of Improvement (PGI-I)
scale 7-points - (very much better) to 7 (very much worse) 8 and 12 after injection
Measured: 36 weeks
Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12
NRS scale: 0 meaning no pain and 10 meaning the worst pain imaginable)
Measured: 36 weeks
Headache Impact Test (HIT-6)
HIT-6 at week 8 and 12 after injection
Measured: 36 weeks
Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Measured: 36 weeks
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Measured: 36 weeks
Acceptability
Acceptability
Measured: 36 weeks
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start3 Oct 2022
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. A 4 weeks screening/baseline period with a daily electronic headache diary (eDiary) follows inclusion and informed consent. After completing the 4-week screening/baseline period, participants will be re-screened and eligible participants will enter the randomized phase of the study consisting of two treatment periods. The treatment periods is either injections with verum (onabotulinum toxin suspended in saline (Botox® and NaCl 0,9% Braun) or placebo (only NaCl 0,9% Braun). The participants are randomized to the order with which they enter the two periods, and a quadruple-blinding regime is implemented. Each treatment period lasts 12 weeks, separated by a 4 week washout period. Participants continue to keep a daily eDiary and register adverse events in the entire randomized period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Sandvika Nevrosenter
- Responsible party
- Sponsor
- Investigators
- Norunn Hanssen Hestvik, Study director, Clinic for Medicine and rehabilitation, Nord Trøndelag Trust HNT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857671
- Sponsor's protocol ID
- 90953
- Other IDs
- 2019-001385-16, 2019
- Acronym
- BACT
- Status last verified
- Mar 2025
- First submitted
- 20 Apr 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BACT - Botulinum Toxin A in Frequent and Chronic Tension-type Headache With the FollowTheSutures Paradigm. A Double Blind, Randomized, Placebo-controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT04857671
- Acronym / sponsor ID
- BACT / 90953
- Conditions
- Tension-Type Headache
- Keywords
- Botulinum toxins, type A, Injections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Sandvika Nevrosenter
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACT studies the efficacy of treatment with botulinum toxin with a follwthestuture injection regime in frequent and chronic tension type headache (TTH). This is be a randomized, placebo-controlled, triple blind, cross-over trial. The primary efficacy variable is the difference in monthly headache days in the active period versus the placebo period. In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. The target population is male and female patients 18 to 75 years of age with TTH, with 10 or more headache days per month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study, injections will follow a slightly modified FollowTheSutures injection protocol. Study duration is 36 weeks long. A 4 weeks screening/baseline period with a daily electronic headache diary (eDiary) follows inclusion and informed consent. After completing the 4-week screening/baseline period, participants will be re-screened and eligible participants will enter the randomized phase of the study consisting of two treatment periods. The treatment periods is either injections with verum (onabotulinum toxin suspended in saline (Botox® and NaCl 0,9% Braun) or placebo (only NaCl 0,9% Braun). The participants are randomized to the order with which they enter the two periods, and a quadruple-blinding regime is implemented. Each treatment period lasts 12 weeks, separated by a 4 week washout period. Participants continue to keep a daily eDiary and register adverse events in the entire randomized period.
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin A injections | Experimental | Drug: Botulinum Toxin Type A in saline water, Drug: Isotone saline waterBotulinum toxin A (Botox) |
| placebo injections | Placebo comparator | Drug: Botulinum Toxin Type A in saline water, Drug: Isotone saline waterIsotone saline water |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A in saline waterAlso: Botox100 Allergan units Botulinum toxin A in a total of 2 ml sodium chloride (NaCl) 0,9% Braun. 5 IU of Botox per injection point (0,1ml); in total 100 IU per 20 injections points. | Drug | Botulinum toxin A injections, placebo injections |
| Isotone saline waterAlso: Sodium chloride solution, NaCl solution2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points | Drug | Botulinum toxin A injections, placebo injections |
Primary outcome
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period.
Time frame: 36 weeks
Difference in TTH- headache days in week 5-8 of the active period versus the placebo period.
11 secondary outcomes
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Time frame: 36 weeks
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Quality of life score on EQ-5D-5L
Time frame: 36 weeks
Patient Global Impression of Improvement (PGI-I)
Time frame: 36 weeks
Average maximum pain intensity in Numeric Rating Scale (NRS from 0 to10) in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Headache Impact Test (HIT-6)
Time frame: 36 weeks
Average number of headache hours per day in week 1-4, 5-8 and 9-12.
Time frame: 36 weeks
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
Time frame: 36 weeks
Acceptability
Time frame: 36 weeks
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norunn Hanssen Hestvik study director
Clinic for Medicine and rehabilitation, Nord Trøndelag Trust HNT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A in saline water and Isotone saline water in people with Tension-Type Headache, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in TTH-headache days in week 5-8 of the active period versus the placebo period. (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.