Expanded Access Program with Tirasemtiv for the Treatment of Amyotrophic Lateral Sclerosis (ALS)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 18-007371
Sponsor Protocol Number: CY 4034
About this study
The purpose of this study is to make Tirasemtiv available to a limited group of patients who suffer from ALS, who participated in CY 4031 and CY 4033, and, in the opinion and the clinical judgment of the treating pPhysician, would benefit from continued treatment with Tirasemtiv
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Able to comprehend and willing to sign an ICF. If verbal consent is given, a Legal Designee (designated person of trust) of the patient may sign the ICF.
- Has not permanently discontinued Tirasemtiv in the CY 4033 study at the time of transition to the EAP.
- Has not taken another investigational study drug (other than Tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater.
- Is not using Tizanidine or Theophylline-containing medications during program participation.
- Is not participating or planning to participate in a clinical trial involving stem cell therapy for the treatment of ALS or another investigational drug.
- Female and male patients of reproductive potential willing to take appropriate precautions to avoid pregnancy while being treated with tirasemtiv in the EAP. Permitted methods in preventing pregnancy should be communicated to the patient and their understanding confirmed by the treating physician.
- Patients must be clearly and completely informed by the treating Physician and sign the ICF, before the start of treatment in the EAP.
Exclusion Criteria:
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bjorn Oskarsson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available