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:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT00237458
Eligibility Criteria:
Inclusion Criteria:
* Subject is informed and given ample time and opportunity to think about her/his participation in this extension trial and has given her/his written informed consent
* Subject met all inclusion criteria defined in the SP611 trial with SPM927 at the time of enrollment into trial SP611
* Subject has successfully completed trial SP611 and, in the investigator's opinion, would benefit from long-term administration of SPM927
* Subject is willing and able to comply with all trial requirements, including the ability to complete trial questionnaires
Exclusion Criteria:
* Subject previously participated in this trial
* Subject has participated in another trial of an investigational drug within the last 3 months (excluding trial SP611) or is currently participating in another trial of an investigational drug
* Subject has had prior therapy with a Nonsteroidal Anti-inflammatory Drug (NSAID) or Anti-epileptic Drug (AED) within 28 days prior to the Eligibility Visit
* Subject has evidence or history of significant Cardiovascular Disease within 12 months prior to the Eligibility Visit
* Subject has laboratory values, which are outside the normal range and judged by the Investigator to be clinically significant
* Subject has abnormal Renal or Hepatic function
* Subject has a history of Malignancies with the exception of subjects with a documented disease-free interval of 5 years or more
* Subject has a history of chronic alcohol or drug abuse within the last 12 months
* Subject has any medical or psychiatric condition which, in the opinion of the Investigator, could jeopardize or compromise the subject's ability to participate in this continuation trial
* Subject with a known history of severe Anaphylactic Reaction and/or serious or life threatening Blood Dyscrasias
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00237458
Study Brief:
Protocol Section:
NCT00237458