NISCI - Nogo Inhibition in Spinal Cord Injury

University of Zurich (UZH)

Status and phase

Completed

Phase 2

Conditions

Spinal Cord Injury, Acute

Treatments

Drug: NG-101

Drug: Placebos

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT03935321

EudraCT No. 2016-001227-31

Details and patient eligibility

About

The purpose of the NISCI trial is to test if an antibody therapy can improve movement and quality of life of tetraplegic patients. A previous trial showed this treatment is safe and well accepted. This is a placebo controlled, randomized, double blind, multicenter, multinational study to assess the safety, tolerability, feasibility and preliminary efficacy of early (within 4-28 days post injury) initiation of treatment with repeated bolus injections of NG-101 in cervical acute SCI patients. The study has 3 phases: screening/baseline Phase, treatment phase, and a follow-up phase.

The study design will allow simultaneous enrolment of patients with complete or incomplete SCI. Enrolment and stratification of the patients is based and individualized prediction of upper limb outcomes.

For further information please visit NISCI website: https://nisci-2020.eu

Enrollment

129 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute cervical spinal cord injury (SCI) (Neurological level of injury C1-C8 with confirmed classification of ASIA impairment scale (AIS) A-D at screening and predicted upper extremities motor score (UEMS) recovery of less than 41/50 (according to the URP prediction model)
4-28 days post-injury
No required mechanical ventilation or patients that not completely depend on mechanical ventilation
Hemodynamically and clinical stable patient according to the acute SCI condition at baseline
Written informed consent
Cooperation and willingness to complete all aspects of the study
Ability of subject to understand character and individual consequences of the study

Exclusion criteria

Complete anatomical transection confirmed by magnetic resonance imaging (MRI)
Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
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 such as lung, liver (exception: history of uncomplicated Hepatitis A), gastorintestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
History of or an acute episode of Guillain-Barre syndrome
History of recent (6 months) meningitis or meningoencephalitis
History of refractory epilepsy
History of or current autoimmune disease
Patients with uncontrolled bleeding diathesis and/or who require concomitant treatment with coumarin anticoagulant
Presence of any unstable medical or psychiatric condition
Drug dependence any time during the 6 month's preceding study entry
Pregnant or nursing women
History of a life-threatening allergic or immune mediated reaction
Patients with the 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
History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure