Spinal Cord Injury - Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN)

Moleac

Status and phase

Completed

Phase 4

Conditions

Spinal Cord Injury

Treatments

Drug: NeuroAiD

Study type

Interventional

Funder types

Industry

Identifiers

NCT02537899

SATURN2015

Details and patient eligibility

About

SATURN investigates the promising role of NeuroAiD in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.

Full description

SATURN is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as American Spinal Injury Association Impairment Scale A and B, who are treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
Age 18 to 65 years
Diagnosed with spinal cord injury between 3 days and 4 weeks
American Spinal Injury Association Impairment Scale A or B
Informed consent for inclusion into the database is obtained

Exclusion criteria

Non survivable injury
Multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury
Other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc)
Refusal of treatment or contraindication to NeuroAiD