Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT02571335
Eligibility Criteria:
Inclusion Criteria:
Key inclusion criteria for the participants' eligibility are a definite MS diagnosis (McDonald criteria). Participants fulfilling the key inclusion and the following criteria are eligible for this study
* EDSS 1.0 - 6.0
* Age 19 - 75 years
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
* Persistent infections
* Severe cardiovascular and pulmonal diseases (renal failure, hepatic dysfunction, cardiovascular disease)
* Severe cardiovascular exacerbations (RR \> 240/120, HR above the age predicted maximum of 220-Age) during training
* Immunosuppressive therapy the day of CPET
* Life style factors and / or persistent addictions (drug or alcohol abuse)
* Inability to follow the study procedures (due to psychological disorders or dementia)
* Insufficient knowledge of the project language (German)
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his / her family members, employees and other dependent persons,
* Specific exclusions for the disease under study,
* Specific concomitant therapy washout requirements prior to and/or during study participation,
* Dietary restrictions
Exclusion Criteria: Criteria in which the participant withdraws from this study may be the following:
* Inability to comply with the daily schedule
* Strong symptom exacerbations
* Withdrawal of informed consent
* Non-compliance
* Disease progression or relapse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02571335
Study Brief:
Protocol Section:
NCT02571335