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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT00812851
Eligibility Criteria:
Inclusion Criteria:
* Patients must be at least 18 years of age and have full legal capacity
* Patients must voluntarily give written informed consent
* Patients diagnosed with possible, probable laboratory supported, probable or definite ALS according to the revised El Escorial criteria (Brooks 2000)
* Patients must score severity of cramps on the VAS 5 or more
* Patients must be able to communicate and report adverse events by phone
* Patients must have laboratory parameters within the following limits: Creatinine, Bilirubin,Transaminases less than 3x upper limit of normal
* Patients may take any medication for the treatment of ALS (ALS -specific and -symptomatic) but may not change this medication during the study period
* Patients must not have cannabis or cannabinoids for at least one month prior to the study and agree not to use it at all during the study. They have to have a negative urinary test for cannabinoids at baseline
* Pre-menopausal females must provide negative pregnancy test within fourteen days before beginning of study participation and have to apply adequate (barrier) birth-control methods
* Patients must agree not to drive a vehicle or use dangerous machines during the entire study period
Exclusion Criteria:
* Patients who are not willing or able to sign the consent form. Doubt of investigator concerning compliance of the patient
* Patients who have a history of failure to respond to, or had significant adverse effects from or hypersensitivity to THC or any cannabinoid
* Patients who have significant concomitant illness(-es), or acute, uncontrolled infections, which might make evaluation of treatment and side effects difficult
* Patients with a history of significant psychiatric disorder, explicitly of schizophrenia
* Patients who are current drug abusers, including alcohol abusers
* Patients with severe coronary artery disease or hemodynamically relevant ECG-documented arrhythmia
* Pregnancy or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00812851
Study Brief:
Protocol Section:
NCT00812851