E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with relapsing remitting multiple sclerosis (RRMS) treated with interferoneβ, suffering from flu-like syndrome (FLS). |
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E.1.1.1 | Medical condition in easily understood language |
Patients with multiple sclerosis treated with interferoneβ, suffering from flu-like syndrome (FLS). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 evaluate the effectiveness of the administration of cetirizine 10 mg on the improvement of the symptoms of FLS. The primary objective of the study was the mean change in subjective seriousness of the FLS, evaluated according to the judgment of the patient on a visual analogue scale (VAS-FLS). |
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E.2.2 | Secondary objectives of the trial |
The average variation of the severity of FLS (as assessed by the score of the symptoms of FLS (FLS-S)) between the measurements before injection, after 4-6 hours after injection and after 12-15 hours after injection during the entire study period, the proportion of patients with an average decrease ≥ 2 points of FLS-S and the incidence of FLS (defined as increase of 2 or more points of FLS-S compared to the value before injection) after 4-6 hours after injection and after 12-15 hours of injection during the entire study period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Individuals of both sexes. • Persons aged between 18 and 55 years • Individuals with Relapsing Remitting Multiple Sclerosis (RRMS). • Treatment with IFNβ 1a (im or sc) or 1b for at least 3 months. • Negative pregnancy test performed no more than 30 days after the baseline visit (if applicable) • FLS-S ≥ 2 in spite of standard therapy (SOT) for the FLS. • Individuals who do not have clinically significant conditions or situations, with the exception of MS, which in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. • Ability to provide written informed consent for participation in the study. • Use of effective birth control methods or conditions of menopause for at least 6 months (if applicable). |
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E.4 | Principal exclusion criteria |
• Subjects (male or female) of childbearing potential who are not using contraceptives • Women who are pregnant or breast-feeding • Intolerance or known contraindications to the use of cetirizine. • Condition hereditary of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption • Simultaneous participation in other studies |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The score of the VAS-FLS scale will be detected prior to injection, 4-6 hours after injection of interferon β and after 12-15 hours after the injection of interferon β during the period of study. |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The score of the symptoms of FLS (FLS-S) between the detections before injection, after 4-6 hours after the injection of interferon β and after 12-15 hours after the injection of interferon β during the entire study period . |
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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 | 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) | Yes |
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.8.2.4 | 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 | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |