Frequent and chronic tension-type headache
Conditions
Interventions
Trade Name: Botox
Product Name: Botox
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramus
Sponsors
Clinic for Medicine and rehabilitation, Nord-Trondelag Trust (HNT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 to 75 years with frequent or chronic tension type headache according to ICHD-3 with 8 or more headache days per month. 2. Headache history of minimum one year. 3. Previously failed treatment with intolerable side-effects to or contra-indications to at least one TTH prophylactic drug. 4. Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period. 5. 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. 6. Signed informed consent. Exclusion criteria: 1. Patients with migraine with more than 1 migraine day per month. 2. Patients with other forms of primary or secondary headaches; including medication overuse headache (MOH). 3. Change in type, dosage or dose frequency of preventive headache or sleep medications =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Patients with migraine with more than 1 migraine day per month. 2. Patients with other forms of primary or secondary headaches; including medication overuse headache (MOH). 3. Change in type, dosage or dose frequency of preventive headache or sleep medications < 1 months prior to inclusion. 4. Previous exposure at any time to any botulinum toxin serotype. 5. Pregnancy, breastfeeding or planned pregnancy. 6. Inadequate contraceptive use. Women of childbearing potential (WOCBP) who do not use highly effective contraception (HEC) will be excluded. 7. 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; 8. Subject currently has an active local infection at the sites of injection based on present symptoms. 9. 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. 10. Serious psychiatric disease that may affect study in opinion of study investigator. 11. Other severe chronical pain conditions. 12. Abuse of alcohol or illicit drugs. 13. Participating in another trial that might affect the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The mainmobjective of the trial is to evaluate effect of botulinum toxin in a cohort of patients with 8 or more days of tension type headache per month. ;Secondary Objective: -To identify predictors for effect of the medication in responders versus non-responders -To increase awareness of TTH and its socioeconomic implications;Primary end point(s): Number of headache days per month: ;Timepoint(s) of evaluation of this end point: After unblinding at study end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Headache severity measured by VAS: pain intensity and severity score from 0 to 10. - Duration of headache per day: in hours. - Number of days of symptomatic therapy with pain-killers per month. - Quality of life measures (EQ-5D-5L) - Patient Global Impression of Improvement (PGI-I). ;Timepoint(s) of evaluation of this end point: After unblinding at study end | — |
Countries
Norway
Contacts
Public ContactPrincipal invest. Kristina Devik
Clinic for Medicine and rehabilitation, Nord-Trondelag Trust (HNT)
Outcome results
None listed