Spinal Muscular Atrophy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 3 years old or older
• You have been diagnosed with Spinal Muscular Atrophy (SMA) and are a candidate for a drug called Spinraza (nusinersen)
• You have difficulty receiving spinal injections (lumbar punctures) safely — either because breathing problems or other health conditions make repeated anesthesia and X-ray exposure risky, or because your doctor believes the device being studied is otherwise in your best interest
• Your doctor has prescribed Spinraza to be delivered through a special implanted port system, and the first use of that port is planned within 2 weeks of the device being put in
• Your doctor determines you are able to have a surgical procedure (either minimally invasive or open surgery) to implant the port and catheter, with at least a small length of tubing placed in the spinal fluid space
• You (or your legal guardian) are willing and able to give written consent to participate
• You and your parent or caregiver are able and willing to attend all required study visits and complete all study procedures

Who may not be able to join:

• You have any health conditions that make the ThecaFlex DRx™ device unsafe for you to use (confirm with trial site)
• You have had, or currently have (within the last 6 months), another implanted drug delivery device, spinal catheter, fluid drainage shunt, or reservoir in the spinal fluid space
• You are pregnant, breastfeeding, or planning to become pregnant during the study
• You have severe physical characteristics that would make it unsafe to implant the catheter or port
• You have had a major medical event within the last 60 days
• You have had surgery involving the head, neck, or back within the last 60 days, or have such surgery planned during the study period
• You have certain structural brain or spine conditions, such as a mass pressing on brain or spinal tissue, a growth at the base of the skull, or a condition called Arnold-Chiari malformation (confirm with trial site)
• You have problems with blood clotting or low platelet levels
• You do not have enough skin or body tissue to safely cover and protect the implanted port
• You have a medical reason why you cannot receive Spinraza
• You have a history of a type of tissue growth (granuloma) forming around spinal catheters
• You have had a spinal fluid infection (bacterial or aseptic meningitis) within the last 6 months
• You have a history of tumors or other spinal abnormalities that would interfere with the catheter placement or spinal fluid flow
• You have a history of a condition causing fluid build-up in the brain (hydrocephalus)
• You have been diagnosed with another muscle-wasting disease in addition to SMA
• You have a history of depression, significant memory or thinking problems, or behavioural issues that your doctor believes could make participation unsafe
• Your doctor believes your current medical condition may mean a life expectancy of less than 12 months
• You are currently taking part in another medical device research study

Important: Always verify eligibility with the trial site directly before applying.