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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT00561366
Eligibility Criteria:
Inclusion Criteria:
* Familial or sporadic ALS.
* Diagnosed with laboratory-supported probable, probable or definite ALS according to the World Federation of Neurology El Escorial criteria for less than or equal to 36 months' duration prior to the Screening Visit.
* Vital capacity (VC) equal to or greater than 70% predicted value for gender, height and age at the Screening Visit.
* Geographic accessibility to the study site.
* Ability to take oral medication at the Screening Visit, based on verbal report.
* Fluency in English, Spanish or Canadian French.
Exclusion Criteria:
* History of known sensitivity or intolerability to arimoclomol or to any other related compound.
* Prior exposure to arimoclomol through a clinical trial or physician-sponsored IND.
* Exposure to any investigational agent within 30 days of the Screening Visit.
* Presence of any of the following clinical conditions:
1. Substance abuse within the past year
2. Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active malignancy or infectious disease
3. AIDS or AIDS-related complex
4. Unstable psychiatric illness defined as psychosis (hallucinations or delusions), untreated major depression within 90 days of the Screening Visit.
* Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, creatinine clearance less than 70 cc/min, alanine aminotransferase (ALT) greater than 3.0 times the upper limit of normal, total bilirubin greater than 1.5 times the upper limit of normal, white blood cell (WBC) count less than 3,500/mm3, platelet concentration of \<100,000/ul, hematocrit level of less than 33 % for female or less than 35 % for male, or coagulation tests (PT, PTT) greater than or equal to 1.5 times upper limit of normal.
* Female volunteers who are breast-feeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00561366
Study Brief:
Protocol Section:
NCT00561366