E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10028037 |
E.1.2 | Term | Movement disorders (incl parkinsonism) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Explorative, hypothesis-generating |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Explorative, hypothesis-generating |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as”the last visit of the last subject undergoing the clinical study” |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |