Botulinum Toxin A in Frequent and Chronic Tension-type Headache

NCT ID: NCT04857671

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2024-12-04

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Botulinum toxin A injections

Botulinum toxin A (Botox)

Group Type: EXPERIMENTAL

Botulinum Toxin Type A in saline water

Intervention Type: DRUG

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 water

Intervention Type: DRUG

2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points

placebo injections

Isotone saline water

Group Type: PLACEBO_COMPARATOR

Botulinum Toxin Type A in saline water

Intervention Type: DRUG

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 water

Intervention Type: DRUG

2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points

Interventions

Botulinum Toxin Type A in 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.

Intervention Type: DRUG

Isotone saline water

2ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 20 injections points

Intervention Type: DRUG

Other Intervention Names

Botox; Sodium chloride solution; NaCl solution

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Sandvika Nevrosenter

UNKNOWN

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Norunn Hanssen Hestvik

Role: STUDY_DIRECTOR

Clinic for Medicine and rehabilitation, Nord Trøndelag Trust HNT

Locations

Namsos Sykehus

Namsos, , Norway

Countries

Norway

Other Identifiers

2019-001385-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

90953

Identifier Type: -

Identifier Source: org_study_id