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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT02434666
Eligibility Criteria:
Inclusion Criteria:
1. Have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating any procedures of the study.
2. Have safely completed 12 week maintenance phase of CPC-001-07 study.
Exclusion Criteria:
1. Renal and hepatic dysfunction with:
Total Bilirubin: \>1.5 x UNL AST: \>2.5 x UNL ALT: \>2.5 x UNL Serum Creatinine: \>1.5 x UNL Creatinine Clearance: \<30 mL/min (calculated by Cockcroft and Gault equation)
2. History or presence of myasthenia.
3. ECG findings of:
Complete Left Bundle Branch Block; Ventricular pacing; 2nd degree or 3rd degree AV block; Atrial fibrillation or atrial flutter; HR \<45 or \>100; PR \>220 msec; or QTcF \>450 msec in male, \>470 msec in female
4. Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
5. Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
89 Years
Study:
NCT02434666
Study Brief:
Protocol Section:
NCT02434666