NG004 in Incomplete Spinal Cord Injury Patients (SPROUT-2)

NovaGo Therapeutics AG

Status and phase

Enrolling

Phase 1

Conditions

Trauma Nervous System

Spinal Cord Injuries

Acute Spinal Cord Injury (SCI)

Spinal Cord Diseases

Treatments

Drug: NG004

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07840196

2026-526089-26 (EudraCT Number)

NG004-SCI-002

Details and patient eligibility

About

This is a randomized, double-blind, placebo controlled, multicenter trial of NG004 in patients with acute traumatic incomplete cervical SCI. The trial will evaluate the safety and tolerability, PK, and effects on motor function and daily life functioning of NG004 compared with placebo.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) B, C and D at Screening
4-28 days post-injury and no earlier than 4 days after spinal surgery
No required mechanical ventilation or patients that do not completely depend on mechanical ventilation
Hemodynamically and clinical stable patient according to the acute SCI condition at baseline

Exclusion criteria

Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
Multiple levels of clinically relevant spinal cord lesions
Major brachial or lumbar plexus damage/trauma
Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
Other significant pre-existing or current severe systemic disease
History of or an episode of multiple sclerosis or Guillain-Barre syndrome
History of recent meningitis or meningoencephalitis
History of refractory epilepsy
Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
Presence of any unstable medical or psychiatric condition
Drug dependence any time within the last 6 months before Screening
Pregnant or nursing women
History of a life-threatening allergic or immune-mediated reaction
Presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
Patients who are unconscious