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Scalable Expanded Access With Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS

UCI Specialty Area: Neurology
Principal Investigator: Namita Goyal
Official Title: Scalable Expanded Access with Analysis of Neurofilament and Other Biomarkers for Ibudilast in ALS (SEA-NOBI-ALS)
A Study On:
Amyotrophic Lateral Sclerosis ALS
Brain - Neurologic/ Psychologic
Neuromuscular Diseases

Study Description

Eligibility

  1. ALS by "Gold Coast" diagnostic criteria
  2. Age greater than 18 years
  3. Either I) Ineligibility for interventional ALS clinical research participation due to at least one of the following standard exclusion criteria:
  1. Time since onset of weakness due to ALS greater than 36 months
  2. Vital Capacity less than 50% of predicted capacity for age, height, and sex measured (by Slow Vital Capacity (SVC) or Forced Vital Capacity (FVC))
  3. Cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
  4. Geographic inaccessibility from nearest actively enrolling research trial site for a trial the patient would otherwise qualify for, defined as either greater than 200 miles or, in the opinion of the investigator, a distance that would make trial participation infeasible for the particular patient, due to significant disease progression or special logistical circumstances. OR II) 5. Former COMBAT-ALS participant or current participant who has completed dosing in the OLE and may be consented at the final OLE follow-up visit.
  1. Female patients of childbearing potential must use one or more effective methods of contraception throughout the entire EAP and for 30 days after discontinuing MN-166.
  2. Male patients agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire EAP and for 30 days after discontinuing MN-166.
  1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to treating physician's judgment (e.g., psychiatric, cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or ECG changes).
  2. Clinically significant lab abnormalities in the opinion of the treating physician, including, but not limited to: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin greater than 3 times the upper limit of normal (ULN), white blood cell count less than 2500/mm3, platelet count less than 75,000/mm3
  3. Active drug or alcohol abuse
  4. Female patient is lactating, pregnant, or planning pregnancy at Clinical Screening or Lab Screening
  5. Concomitant use of another investigational medical product for treatment of ALS. Any such investigational medical product must be discontinued for a minimum of 5 half-lives prior to the first dose of MN-166.
  6. Concomitant use of prohibited medications. Refer to Program Procedure Manual Appendix 3 for a list of prohibited medications.
  7. Past participant in COMBAT-ALS clinical trial who did not complete the study.
  8. Past participant in an ALS research trial who did not complete the study without cause.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

  • Please read the information below and ask questions about anything that you do not understand. A
    researcher listed above will be available to answer your questions.
  • You are being asked to participate in a clinical research potential participant database to identify
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    You may choose to skip any question. You may refuse to participate or discontinue your involvement
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    immediately    .
  • You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health
  • We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.
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  • There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.
  • There are no alternative procedures available. The only alternative is not to participate in this study.
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  • While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.
  • Future Research Use
    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
  • Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.
  • If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.
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  • Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the researchers listed at the top of the form and have general questions; have concerns or complaints about the research; have questions about your rights as a research subject; or have general comments or suggestions.
What is an IRB? An Institutional Review Board (IRB) is a committee made up of scientists and nonscientists. The IRB’s role is to protect the rights and welfare of human subjects involved in research. The IRB also assures that the research complies with applicable regulations, laws, and institutional policies. UCI