EUCTR2019-001385-16-NO进行中（未招募）1 期
Botulinum toxin A in frequent and chronic tension-type headache. A double blind, randomized, placebo-controlled cross-over trial - BACT
Clinic for Medicine and rehabilitation, Nord-Trondelag Trust (HNT)0 个研究点目标入组 60 人开始时间: 2019年9月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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 < 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.
- •Are the trial subjects under 18? no
- •Number of subjects for thi
排除标准
- •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.
研究者
相似试验
已完成
3 期
Botulinum Toxin A in Frequent and Chronic Tension-type HeadacheTension-Type HeadacheNCT04857671Helse Nord-Trøndelag HF66
进行中（未招募）
1 期
Botulinum toxin-A in Sensory Urgency - BTXSENSSensory Urinary Urgency. This is a condition where patients have urinary urgency (sudden desire to urinate which cannot be deferred) /- urge incontinence (urine leakage) and usually is accompanied by frequency (frequent passage of urineusually > 8/day)and nocturia (passing urine at night ie getting up from sleep). No abnormal bladder muscle overactivity, however, is present.MedDRA version: 9.1Level: LLTClassification code 10059617Term: Overactive bladderEUCTR2006-000129-76-GBGuy's & St Thomas' NHS Foundation Trust64
已完成
不适用
Botulinum toxin-A in sensory urgencySensory urgency, overactive bladderUrological and Genital DiseasesISRCTN57577615Guy's and St Thomas' NHS Trust (UK)64
进行中（未招募）
1 期
Botulinum toxin type A as treatment for chronic facial muscle pain.Chronic myalgia (>6months) in the facial region.EUCTR2021-002784-21-SEVästra Götalandsregionen72
进行中（未招募）
1 期
Botulinum toxin-A as a treatment for chronic muscle-related pain in adults with spastic cerebral palsy: a randomized controlled trial.Spastic cerebral palsyEUCTR2015-000095-10-SEKarolinska Institutet48