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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02071459
Eligibility Criteria:
Inclusion Criteria:
* MSA patients (possible or probable, MSA-P or C (according to revised criteria, Gilman et al 2008)).
* Aged 30 to 80 years,
* Able to walk at least 10 meters
* With symptomatic OH (score of at least 3 at one of the items of Part I of the OH scale (OHQ))
* Documented fall in systolic blood pressure of at least 20 mmHg, and/or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
* Able to fill in the evaluation questionnaires with or without help
* With no significant problems with swallowing.
* Stable anti-parkinsonian, dysautonomia and depression treatments for the 4 weeks before the study and during the entire study
* Signed written informed consent for the present study.
Exclusion Criteria:
* Dementia (DSM-IV, Mini-Mental State Examination (MMSE) \< 24/30)
* Concomitant use of vaso-constrictive drugs, other than midodrine. Patients taking vasoconstrictor agents such as ephedrine, dihydroergotamine, must stop taking these drugs at least 2 days or 7 half-lives prior to their baseline visit (Visit 1); the association with midodrine may be kept at a stable dose not exceeding 3 tablets (7.5 mg) / day if the patient has no CV history. This will be discussed case by case with the coordinating center and the safety committee of this study.
* Taking anti-hypertensive medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02071459
Study Brief:
Protocol Section:
NCT02071459