E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | LLT |
E.1.2 | Classification code | 10013983 |
E.1.2 | Term | Dystonia |
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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 |
To assess if dystonia is associated with a hyperdopaminergic and a hyposerotonergic system. To assess if administration of SSRIs decreases jerks in patients with dystonia. |
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E.2.2 | Secondary objectives of the trial |
To assess if jerky movements in patients with dystonia are associated with a hyposerotonergic system. To assess if depression, anxiety and compulsive-checking behavior in patients with dystonia are associated with a hyposerotonergic system. To assess if administration of SSRIs decreases depressive, anxious and compulsive symptoms in patients with dystonia. To assess if clinical changes in psychiatric symptoms and jerks in patients with dystonia after SSRI use are associated with alterations in the serotonergic and dopaminergic system. To assess if the occupancy of SERTs by an SSRI is associated with a decrease of depressive and compulsive symptoms, anxiety and jerks in patients with dystonia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 35 years or older Primary focal dystonia diagnosed and treated with botulinetoxin injections in the Academic Medical Center Informed consent
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E.4 | Principal exclusion criteria |
Other forms of dystonia SSRI use in the past 6 months prior to or during the study Use of other anti-depressants during the study, especially MAO-B inhibitors Symptomatic therapy for dystonia other than botulinetoxin, e.g. baclofen or other muscle relaxants. Use of medication with a known effect on dopamine or serotonin receptors or transporters or with a known interaction with Escitalopram (e.g. L-DOPA, dopamine-agonists, ritalin, NSAID’s, aspirin, tryptophan, carbamazepine, etcetera) Pregnancy or nursing
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage difference in D2R, DAT and SERT binding between subjects with focal dystonia and healthy controls. Proportion of patients that change at least 1 point on CGI scale after treatment on jerks.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | 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 | 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 | Yes |
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 | No |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |