A randomized controlled trial of OSU6162 in treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004357-82-SE

Enrollment

Registered

2011-11-03

Start date

2012-02-21

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Interventions

Product Code: OSU6162 similar to (-)-OSU 6162 Pharmaceutical Form: Coated tablet Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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). ;Secondary Objective: 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. ;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.;Timepoint(s) of evaluation of this end point: After 14 days of treatment	—

Measure

Time frame

Main Objective: 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). ;Secondary Objective: 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. ;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.;Timepoint(s) of evaluation of this end point: After 14 days of treatment

—

Secondary

Measure	Time frame
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.;Timepoint(s) of evaluation of this end point: After two weeks of treatment	—

Countries

Sweden

Contacts

Public ContactC-G Gottfries

Gottfries Clinic AB

cgg@gottfries.se+4631343 23 97

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026