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

Phase 1

• Conditions: 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: 12.1Level: HLGTClassification code 10028037Term: Movement disorders (incl parkinsonism)

• Registration Number: EUCTR2009-010282-23-SE
• Lead Sponsor: Tandvården SU/Mölndal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified