E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40)). |
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E.1.1.1 | Medical condition in easily understood language |
Patients diagnosed with a fibromyalgia syndrome |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
S-ketamine (low-dose versus high dose) can significantly improve the quality of life (pain and/or and autonomy) of patients diagnosed with a fibromyalgia syndrome as established by the 2016 ACR criteria and presenting criteria of central sensitization syndrome (based of the CSI (CSI>40)). S-ketamine has therefore its place as one of the treatments of fibromyalgic patients with a central sensitization syndrome not improved by a bio-psycho-social approach established by the EULAR guidelines |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- patients suffering from chronic pain (as defined by IASP) being diagnosed as fibromyalgia according to the ACR 2016 criteria - patients from the Grand Hôpital de Charleroi pain clinic (Sainte-Thérèse) - patients qualified for the treatment by S-ketamine as established by our latest clinical practice - patients aged 18-65 years old - patients having no experience of previous treatment by ketamine or S-ketamine for fibromyalgia - patients with a score > 40 at the central sensitization inventory |
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E.4 | Principal exclusion criteria |
- Pregnant or breastfeeding women (based on patient interrogation and pregnancy test for women in the age to procreate ) A pregnancy discovered during the study will be reported to the ethics committee - Women of childbearing age not using an approved contraceptive method - History of psychiatric disorders as psychosis - Incapacity of giving an informed consent (concerns also patients with a linguistic barrier) - Allergy to any of the products used in the trial - Contraindication to any of the products used in the trial - Patients with any medical condition or medication inconsistent with the study
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E.5 End points |
E.5.1 | Primary end point(s) |
- BPI (Brief Pain Inventory) pain severity scale - BPI (Brief Pain Inventory) pain interference scale
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoints to evaluate will be done at screening, at week 2, at week 4, at week 6, at week 9 and at week 12. |
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E.5.2 | Secondary end point(s) |
- Number of patients showing a 50% reduction in the BPI pain index as asked by the item number 6 of the BPI - Impact of the treatment by esketamine on patient quality of life as measuring by the EQ5D-5L questionnaire - Impact of the treatment on emotional status evaluated by the HADS (Hospital Anxiety and Depression Scale) questionnaire - Incidence of the side effects of the treatment - Patient global satisfaction with the treatment as evaluated by the PGIC (Patient Global Impression of Change scale) questionnaire - Evolution of the central sensitization inventory |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoints to evaluate will be done at screening, at week 2, at week 4, at week 6, at week 9 and at week 12. |
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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 | 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) | 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 | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |