E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Headache attributed to temporomandibular disorder |
Glavobol v zvezi s temporomandibularno motnjo |
|
E.1.1.1 | Medical condition in easily understood language |
Headache caused by a disorder involving structures in the temporomandibular region.
|
Glavobol, ki ga povzroča motnja, ki vključuje strukture v temporomandibularni regiji.
|
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
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 purpose of the study is to determine whether the treatment with the stabilization splint and injections of botulinum toxin is effective in treating headache attributed to temporomandibular disorders. |
Namen raziskave je ugotoviti, ali se da z Michigansko okluzijsko opornico in injekcijami botulinum toksina učinkovito zdraviti glavobol v zvezi s temporomandibularno motnjo |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Ni na voljo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Headache attributed to TMD |
Glavobol v zvezi s TMM |
|
E.4 | Principal exclusion criteria |
• Systemic rheumatic, neurological / neuropathic, endocrine or immune / autoimmune disease or enlarged pain (except rheumatoid arthritis in fibromyalgia). • Radiation in the head area of the neck • Surgical intervention in the TMS area • Trauma in the jaw area over the past 2 months (car accident anytime - absolute exclusion factor). • Presence of oral pain, other than TMM • Pregnancy • Neurological disorders • Inability to participate in research (physical, mental or language barriers) • Use of narcotics, muscle relaxants or steroids, unless it was discontinued 1 week before the survey • Use of antidepressants unless the patient is on stable doses for 60 days • Use of NSAIDs unless the patient discontinues taking at least 3 days prior to the study • Drug abuse • The patient is in the process of treatment with a dentist • TMM therapy unless the patient has been on stable therapies for the last two months • Patient not consent for trial
|
• Sistemska revmatska, nevrološka/nevropatska,endokrina ali imunska/avtoimuna bolezen ali razširjena bolečina (razen revmatoidni artritis in fibromialgija). • Obsevanje v področju glave in vratu • Kirurški poseg v področju TMS • Travma v področju čeljusti v zadnjih 2mesecih (avtomobilska nesreča kadarkoli-absolutni izključitveni dejavnik). • Prisotnost ustnoobrazne bolečine, ki ni TMM • Nosečnost • Nevromišične motnje • Nezmožnost sodelovanja v raziskavi (fizična, mentalna ali jezikovna ovira) • Uporaba narkotikov, mišičnih relaksantov ali steroidov, razen če je ukinjena 1 teden pred raziskavo • Uporaba antidepresivov, razen če je bolnik na stabilni dozi 60 dni • Uporaba NSAR, razen če bolnik prekine jemanje vsaj 3 dni pred raziskavo • Zloraba drog • Bolnik je v procesu zdravljenja pri zobozdravniku • Terapija TMM, razen če je bolnik na stabilni terapiji zadnja dva meseca • Neprivolitev v raziskavo
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The results of the research will be the basis for introducing guidelines for the treatment of headache attributed to TMD. |
Rezultati raziskave bodo osnova za vpeljavo smernic zdravljenja glavobola v zvezi s TMM. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
We expect that a group of patients with both treatment methods at the same time will offer the best results in terms of improving the symptoms of this type of headache |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
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 | No |
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 | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
okluzijska opornica |
stabilization splint |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | No |
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
|
patients will have continuous control visits |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |