- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04857671
Botulinum Toxin A in Frequent and Chronic Tension-type Headache (BACT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Kristina Devik, MD
- Phone Number: +47 74215477
- Email: kristina.devik@helse-nordtrondelag.no
Study Contact Backup
- Name: Tore Wergeland Meisingset, MD PhD
- Phone Number: +47 72521335
- Email: tore.w.meisinget@ntnu.no
Study Locations
-
-
-
Namsos, Norway
- Recruiting
- Namsos Sykehus
-
Contact:
- Kristina Devik, MD
- Phone Number: +47 74215477
- Email: kristina.devik@helse-nordtrondelag.no
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Botulinum toxin A injections
Botulinum toxin A (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.
Other Names:
2ml Na Cl (sodium chloride) 0,9% Braun.
0,1ml per injection point in total 20 injections points
Other Names:
|
Placebo Comparator: placebo injections
Isotone saline water
|
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.
Other Names:
2ml Na Cl (sodium chloride) 0,9% Braun.
0,1ml per injection point in total 20 injections points
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
Time Frame: 36 weeks
|
50% responders (50% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
|
36 weeks
|
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
Time Frame: 36 weeks
|
Difference in TTH-headache days in week 1-4 and 9-12, and in the entire treatment period
|
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
|
30% responders (30% reduction in TTH-headache days from baseline) in week 1-4, 5-8 and 9-12
|
36 weeks
|
Quality of life score on EQ-5D-5L
Time Frame: 36 weeks
|
EQ-5D-5L at week 8 and 12 after injection
|
36 weeks
|
Patient Global Impression of Improvement (PGI-I)
Time Frame: 36 weeks
|
scale 7-points - (very much better) to 7 (very much worse) 8 and 12 after injection
|
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
|
NRS scale: 0 meaning no pain and 10 meaning the worst pain imaginable)
|
36 weeks
|
Headache Impact Test (HIT-6)
Time Frame: 36 weeks
|
HIT-6 at week 8 and 12 after injection
|
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 headache hours per day 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
Time Frame: 36 weeks
|
Average number of days with intake of painkillers per month in week 1-4, 5-8 and 9-12
|
36 weeks
|
Acceptability
Time Frame: 36 weeks
|
Acceptability
|
36 weeks
|
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
Time Frame: 36 weeks
|
Difference in occurrence of adverse events and serious adverse events in the active period and the placebo period
|
36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Norunn Hanssen Hestvik, Clinic for Medicine and rehabilitation, Nord Trøndelag Trust HNT
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Headache Disorders, Primary
- Headache Disorders
- Headache
- Tension-Type Headache
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- Pharmaceutical Solutions
Other Study ID Numbers
- 90953
- 2019-001385-16 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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