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 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT00982150
Eligibility Criteria:
Inclusion Criteria:
* Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-201.
* Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
* Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.
Exclusion Criteria:
* Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
* Patients using any of the following:
* Chronic use of lithium carbonate
* Chronic use of mecasermin (rhIGF-1)
* Chronic use of minocycline
* Chronic use of more than 600mg/day coenzyme Q10
* Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
* Patients participating in any other investigational drug study and use of any other investigational drug
* Patients taking drugs that may interact with Talampanel
* Females who are pregnant or nursing.
* Females of child-bearing potential who do not practice medically acceptable methods of contraception.
* Any condition of the patient which the investigator feels may interfere with participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00982150
Study Brief:
Protocol Section:
NCT00982150