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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.


Zachary Simmons 717-531-8257
Neurology (HERSHEY)

18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
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

Exclusion Criteria:
Use of any moderate or strong CYP3A4 inhibitor or inducer within 10 days or 5 half- lives (whichever is longer) prior to Baseline and throughout the study
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.
Experimental drug compared to a placebo/”sugar pill”
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Location Contacts
Hershey, PA ,