Botulinum Toxin A in Frequent and Chronic Tension-type Headache

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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/ alternative medicine also show poor long-term effects. And literature reviews shoes that there is surprisingly little research on CTTH. Some small clinical trials report a good effect of treatment with botulinum toxin A in CTTH, but larger controlled trials are needed to confirm or deny this.

We will study effect of treatment with botulinum toxin A in CTTH in BACT study, and we will include participants with both frequent and chronic TTH with 10 or more headache days per month.

If BACT outcomes are positive, it will open a possibillity for a new treatment for TTH patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Norway Regional Health Authority; Helse Nord-Trøndelag HF
• Collaborators: Norwegian University of Science and Technology; Sandvika Nevrosenter
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• frequent or chronic tension type headache according to ICHD-3 with 10 or more headache days per month

• Headache history of minimum one year.

• Previously failed treatment with intolerable side-effects to or contra-indications to at least one tension-type headache 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. Such methods 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

• Signed informed consent

Exclusion Criteria:

• migraine with more than 1 migraine day per month

• other forms of primary or secondary headaches; including medication overuse headache (MOH)

• Change in type, dosage or dose frequency of preventive headache or sleep medications < 1 months prior to inclusion

• Previous exposure at any time to any botulinum toxin serotype

• Pregnancy, breastfeeding or planned pregnancy

• Inadequate contraceptive use. Women of childbearing potential (WOCBP) who do not use highly effective contraception (HEC) will be excluded

• 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

• currently having an active local infection at the sites of injection based on present symptoms.

• 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.

• Serious psychiatric disease that may affect study in opinion of study investigator

• Other severe chronical pain conditions

• Ongoing abuse of alcohol or illicit drugs in the opinion of the investigator

• Participating in another trial that might affect the current study