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REGIMEN-SPECIFIC APPENDIX F FOR ABBV-CLS-7262
We are doing this research to find out if ABBV-CLS-7262 can help with Amyotrophic Lateral Sclerosis (ALS). We also want to find out if ABBV-CLS-7262 is safe to take without causing too many side effects.
• Ask you to complete questionnaires about your general health and well-being [Baseline Visit and Weeks 4, 8, 16 and 24/Early Termination (ET) Visits] • Collect a blood sample for: o Testing the amount of study drug in your body [Weeks 4, 8, 16, and 24/ET] o Test certain hormone levels [Regimen Screening, Week 4, 16, and 24/ET] o Test for a bleeding disorder prior to lumbar puncture [Regimen Screening if not done at Master Protocol Screening Visit, Week 16] o Biomarker (including RNA) testing [Baseline Visit, Week 8, 16, and 24/ET] o Over the course of the placebo-controlled portion of this research study, total blood draw volume for the samples listed above will be approximately 32mL or 2 tablespoons per visit • Collect a urine sample for: o Routine safety testing [Baseline Visit, Week 4, Week 8, 16, and 24/ET] o Biomarker testing [Baseline Visit, Week 8, 16, and 24/ET] • Collect electrocardiogram (ECG) to assess for cardiovascular safety [Baseline Visit, Week 8, 16, and 24/ET] • Collect your vital signs (blood pressure, breathing & heart rate, blood oxygen level, and temperature) • Perform a lumbar Puncture to collect spinal fluid [Baseline and Week 24 Visit] • If you are a woman of childbearing potential, you will be asked to complete a Menstrual Cycle Questionnaire throughout the duration of this regimen
You will receive payment for the following: 1. stipend of $50 per on-site visit; 2. stipend of $100 per lumbar puncture (LP requested Weeks 28 and 52); 3. reimbursement for travel of $65 per on-site visit.
Age 18 years or older
Capable of providing informed consent and complying with study procedures, in the SI’s opinion
Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit
Abnormal adrenal function, defined as confirmed abnormal random cortisol (<5 μg/dL) or ACTH (>2x upper limit of normal) at Regimen Specific Screening.
Any clinically significant ECG abnormalities, including QT interval corrected for heart rate using Fridericia’s correction formula (QTcF) of > 450 msec for males or > 470 msec for females at Master Protocol Screening.