Patients with severe oral bruxism according to Polysomnographic cut-off criteria for bruxism: more than 4 bruxism episodes per hour, more than 6 bruxism bursts per episode and/or 25 bruxism bursts per hour of sleep and at least 2 episodes with grinding sounds. MedDRA version: 12.1 Level: HLGT Classification code 10028037 Term: Movement disorders (incl parkinsonism)
Conditions
Interventions
Trade Name: Sifrol
Pharmaceutical Form: Tablet
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
CAS Number: 104632259
Concentration unit: mg milligram(s)
Concentration type: range
Concentration numbe
Sponsors
Tandvården SU/Mölndal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to use dopamine receptor stimulation on bruxism having number of bruxism episodes per hour as the primary variable.;Secondary Objective: Secondary objectives of the study are to evaluate • sleep related variables measured by polysomnography at baseline and after 6 weeks • clinical symptom severity reduction according to the Craniomandibular Index (CMI) at baseline and after 6 weeks • patient-reported outcomes including ESS, KSS, MOS, Pittsburg SI, FOSQ and SF-36 at baseline and after 6 weeks •i ron status at baseline and after 6 weeks;Primary end point(s): • Number of bruxism episodes per hour will be calculated (mean of right and left side). Frequency of treatment responders is defined as more than 25 % reduction of the baseline EMG scored bruxism episodes to to visit 3 and visit 5. • Sleep variables such as total sleep time (TST), time to sleep onset (TSO), number of awa enings (NAW), number of arousals (ARI), and sleep stages (stage I, II, III, IV, REM) in & and absolute time will be measured from at baseline to visit 3 and from visit 3 to visit 5. • Patientent Reported Outcomes assessed by ESS, KSS, Pittsburg SI, FOSQ and SF-36 at baseline to visit 3 and from visit 3 to visit 5. • Iron, iron ferritin, transferrin and receptor transferrin will be analysed at baseline and at baseline to visit 5. | — |
Countries
Sweden
Outcome results
None listed