E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome |
Myalgisk encefalomyelit/kroniskt trötthetssyndrom |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
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 study will be conducted in order to investigate the effect of OSU6162 as compared to placebo on symptoms in the Myalgic Encephalomyelitis (ME) syndrome, especially fatigability. The safety profile of OSU6162 of 30-60 mg/day in 60 patients (men and women) will also be evaluated. Efficacy parameters to be investigated are described.
Primary endpoint is to investigate the therapeutic effects of OSU6162 as measured by the self-assessment questionnaire (Johansson et al 2009) with focus on the mental fatigue and concentration capacity. Another primary endpoint is the result of the rating by the Clinical Global Impression of Change (CGI-C) where the rating is made by the doctor in charge of the patient. CGI-C scores range from 1 (very much improved) through to 7 (very much worse).
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints are the results from the neuropsychological tests, with focus on information processing speed, the FibroFatigue scale with focus on core symptoms of ME and the related syndrome Fibromyalgia, the Becks scale for self-assessment of depression and the VAS scale for self-assessment of pain.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria:
A new set of consensus criteria for the diagnosis ME is presented in Journal of Internal Medicine (International Consensus Criteria, ICC, Carruthers et al 2011). These criteria are a updating of the previous used Fukuda and Canadian Criteria. The set of criteria by Fukuda and the ICC will be applied in this study.
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E.4 | Principal exclusion criteria |
•Unstable therapies are not allowed but stable therapies are allowed. A stable therapy is defined as having started at least 6 months before the study and continued to be unchanged during the study period. Examples of such medications are anti-depressant therapy. Other stable therapies with hypnotics and anxiolytics are also allowed if they are given at doses recommended by the manufacturers. Analgesics such as NSAID, acetyl salicylic acid and paracetamol are permitted as well as stable anti-hypertensive therapy.
•Patients with active substance abuse.
•Pregnant women.
•Women of childbearing age not on contraceptives.
•Uses of acute or chronic medications for other medical conditions are allowed based on clinical judgment. Occasional use of over-the-counter (OTC) medications is allowed at the investigator's discretion. All concomitant medications, whether OTC or prescription, are required to be noted on the Concomitant Medication form.
•Abnormal laboratory parameters judged to be clinical relevant such as Hb, white blood cells count, electrolytes, tests of liver and kidney functions, TSH, T4, B12, folic acid.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint is to investigate the therapeutic effects of OSU6162 as measured by the self-assessment questionnaire (Johansson et al 2009) with focus on the mental fatigue and concentration capacity. Another primary endpoint is the result of the rating by the Clinical Global Impression of Change (CGI-C) where the rating is made by the doctor in charge of the patient. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 14 days of treatment |
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E.5.2 | Secondary end point(s) |
Secondary endpoints are the results from the neuropsychological tests, with focus on information processing speed, the FibroFatigue scale with focus on core symptoms of ME and FM, the Becks scale for self-assessment of depression and the VAS scale for self-assessment of pain. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After two weeks of treatment |
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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 | Yes |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | 10 |
E.8.9.1 | In the Member State concerned days | |