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 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT06528392
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-80, men and women, capable of giving informed consent.
2. Must have unexplained stiffness of limb and axial (trunk) muscles and involuntary striated muscle spasms.
3. DSI and HHS must be \>=2 (to allow for detection of improvement).
4. Presence of serum (or CSF) anti-GAD antibodies regardless of titers.
5. Stable dosage for at least two months before screening visit with antispasmodics (muscle relaxants, benzodiazepines, baclofen).
6. Women with children bearing potential must be willing to use highly effective contraception method during and for a minimum of 90 days after the last dose of IP.
Exclusion Criteria:
1\. Exclusionary conditions:
1a. type 1 DM
1b. Cancer, except basal cell skin cancer
1c. Infections: HIV, Hepatitis B or C, clinically significant active infection not sufficiently resolved in the investigator's opinion
1d. Serum IgG (\<6 g/L) at screening
1e. pregnancy/breast feeding. 2. Exclusionary medications: rituximab within 6 months of screening. 3. IVIG or PLEX treatment 4 weeks prior to screening. 4. History of any type of solid organ or bone marrow transplant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06528392
Study Brief:
Protocol Section:
NCT06528392