NG004 for Acute incomplete cervical spinal cord injury

Inclusion criteria

• {"criterion_text":"- Male or female\n- Ability of patient to understand character and individual consequences of the trial\n- 18 to 75 years of age, inclusive\n- Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with a) confirmed classification of American Spinal Injury Association (ASIA) impairment scale [CCI] at Screening and b) Nodes [CCI] according to the unbiased recursive partitioning (URP) prediction model for predicted mean UEMS recovery c) UEMS at Screening and Baseline <[CCI]\n- Trial treatment can be initiated by first i.t. bolus injection upon eligibility confirmation within 4-28 days post-injury\n- Tetraplegic patients who are allowed to start treatment are those who either do not require mechanical ventilation or who do not completely depend on mechanical ventilation but show some degree of spontaneous ventilation. Only those modes of ventilation where the patients show active initiation of breathing are allowed (eg, continuous positive airway pressure)\n- Hemodynamically and clinically stable according to the acute SCI condition at Baseline\n- For patients of childbearing potential, use of reliable means of contraception as described below during the treatment phase and for at least 6 months after the last dose of IP: a) Men and women of childbearing potential, who are willing to use a highly effective method of contraception [either combined hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner or sexual abstinence)], or women not of childbearing potential, defined as women who have been surgically sterilized (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization) or have been postmenopausal for at least 2 years. Individuals who are convincingly sexually abstinent are also eligible. b) Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\n- Written informed consent by patient or witness (for patients who could consent only verbally), provided prior to participation in the trial\n- Cooperation and willingness to complete all aspects of the trial"}

Exclusion criteria

• {"criterion_text":"- Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds\n- Presence of any unstable medical or psychiatric condition (defined by the Diagnostic and Statistical Manual of Mental Disorders, Edition 4 [DSM-IV]) that may expose the patient to an unwarranted risk from participation in the trial or result in a significant deterioration of the patient’s clinical course\n- Drug dependence (as defined by DSM-IV) any time within last 6 months before Baseline\n- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a woman after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (>5 mIU/mL)\n- History of a life-threatening allergic or immune-mediated reaction\n- Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections\n- Inability to communicate effectively with the neurological examiner such that the validity of the patient’s data may be compromised\n- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations\n- Patients who are unconscious, including those patients who are unconscious due to medication causing marked sedation\n- Known hypersensitivity to any excipients of the IP or to any drug with similar chemical structure\n- Multiple levels of clinically relevant spinal cord lesions (CAVE: patients with stable fractures eg, on a thoracic level can be included)\n- Major brachial or lumbar plexus damage/trauma\n- Significant head trauma (eg, cortical damage/lesion), or other injury that is, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function or may otherwise compromise the validity of the patient’s data\n- Other significant pre-existing or current severe systemic diseases such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy or any other condition as determined by history or laboratory investigation that could cause a neurological deficit including syphilis, myelopathy, clinically relevant polyneuropathy, etc.\n- History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome\n- History of recent meningitis or meningoencephalitis (within last 6 months before Baseline)\n- History of refractory epilepsy\n- Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation (eg, phenoprocoumon [Marcumar®], heparin/heparinoids and new oral anticoagulants at a higher dose than for the prophylaxis of venous thromboembolism) and not related to SCI"}

Primary endpoints

• {"endpoint_text":"- Type, frequency, severity, and causal relationship of adverse events (AEs), serious AEs (SAEs), and adverse drug reactions (ADRs)","definition_or_measurement_approach":"Assessment and recording of AEs, SAEs and ADRs including type, frequency, severity and causality as captured during the study (safety/tolerability monitoring)."}
• {"endpoint_text":"- Safety laboratory, electrocardiogram (ECG), vital signs, physical and neurological examination, muscle spasticity (Modified Ashworth Scale), and pain (condensed version of the EMSCI Pain Assessment Form [NePAF])","definition_or_measurement_approach":"Measured by laboratory safety tests, ECG recordings, vital sign assessments, physical and neurological exams, Modified Ashworth Scale for spasticity and NePAF for pain."}

Secondary endpoints

• {"endpoint_text":"- PK parameter in serum and NG004 concentration in cerebrospinal fluid (CSF)","definition_or_measurement_approach":"Pharmacokinetic parameters measured in serum and NG004 concentrations measured in CSF samples."}

Germany

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

508

Number Of Sites

4

Number Of Participants

19

Primary sponsor

Full Name

NovaGo Therapeutics AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

FGK Clinical Research GmbH

Responsibilities

Multiple sponsor duties including monitoring/regulatory activities (codes: 1,5,6,7,8,10,11,12,15); contacts: anett.kaiser@fgk-cro.com; ra.ctis@fgk-cro.com

Name

QPS Netherlands B.V.

Responsibilities

Sponsor duty code: 4; contact anouk.la.rose@qps.com

Third parties

• {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"codes: 6; contact anett.kaiser@fgk-cro.com, phone +4930235918331","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"FGK Clinical Research GmbH","duties_or_roles":"codes: 1,10,11,12,15 (eTMF),5,7,8; contact ra.ctis@fgk-cro.com, phone +49898931190","organisation_type":"Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Lyo-X AG","duties_or_roles":"codes: 10; contact info@lyo-x.com, phone +41797665270","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"QPS Netherlands B.V.","duties_or_roles":"codes: 4; contact anouk.la.rose@qps.com, phone +31621996280","organisation_type":"Pharmaceutical company"}