EUCTR2009-010282-23-SE进行中（未招募）1 期
A randomized, open-label, cross-over study to explore a potential involvement of a dopamine related dysfunction as a mechanism behind bruxism - Studera effekt av en dopaminagonist på patienter med bruxism
Tandvården SU/Mölndal0 个研究点目标入组 20 人开始时间: 2010年9月30日最近更新:
适应症
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
- 20
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
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. Female and male aged 18-70 years
- •3. Obvious tooth abrasions, fractured cusps and abnormal wear of the teeth, broken restorations and grinding noise noted by sleep partner
- •4. At least 3 years history of bruxism according to patient statement
- •5. Fulfil PSG cut-off criteria for bruxism (Lavigne et al 1996)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous randomization of treatment in the present study
- •2. Participation in another clinical study during the last 1 month
- •3. Extensive removable dentures
- •4. Women of child-bearing potential (i.e. premenopausal women or postmenopausal women less than 6 months after last menses) who, during the clinical trial, do not use an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicidal), intrauterine device, hormonal therapy (, injectable, or subcutaneous), or partners surgical sterilization
- •5. Breastfeeding women
- •6. Concomitant or previous pharmacologic therapy for RLS as follows: Any intake of dopamine agonists within 14 days prior to baseline (Visit 2), any intake of levodopa within 14 days prior to baseline (Visit 2), unsuccessful prior treatment with non-ergot dopamine agonists (e.g. PPX, ropinirole).
- •7. All treatment less than 14 days before baseline (Visit 2) or concomitant treatment with medication or dietary supplements which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa and dopamine agonists) or antidopaminergic drugs, non-selective MAO inhibitors, sympathomimetics, neuroleptics, antidepressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, ferrous salts, magnesium, folic acid, vitamin B12, antihistamines, lithium and metoclopramide.
- •8. Previous PPX non-responders in other indications than bruxism
- •9. Patients with known hypersensitivity to PPX
- •10. Diagnosis of diabetes mellitus requiring insulin therapy
- •11. Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion
- •12. History of /or malignant melanoma
- •13. Reduced hepatic function at the discretion of the investigator
- •14. Porfyria cutanea tarda (PCT)
- •15. History of/or clinically significant vision abnormalities
- •16. History of/or any other sleep disorder (other than RLS related), such as Rapid Eye Movement- (REM-) sleep disorder, narcolepsy, or sleep apnea syndrome
- •17. History of/or major depressive disorder or any psychotic disorder, mental disorders or any present Axis I psychiatric disorder according to DSM IV requiring any medical therapy
- •18. History of/or clinical signs of suicidal behaviour, suicide ideation or acute suicidal tendency according to the investigators opinion
- •19. History of/or alcohol abuse or drug addiction within the last two years before screening
- •20. Patients with any clinically significant conditions that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health hazard for the patient
- •21. Inability to understand and complete the questionnaires
- •22. Patients with severe cardiovascular condition according to the investigators judgement
- •23. Treatments with cimetidin, amantdin, mexiletin
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