Traumatic Brain Injury (TBI)
Conditions
Interventions
Product Name: JNJ-17299425-AAA Solution
Product Code: JNJ-17299425
Pharmaceutical Form: Solution for injection
CAS Number: none
Current Sponsor code: JNJ-1729925
Other descriptive name: JNJ-17299425-A
R160371
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.1, 1, 10-
Sponsors
Janssen-Cilag International N.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with traumatic head injury (GCS: greater than or equal to 8/15 before ventilation) and requiring ventilation and intra-cranial pressure monitoring. Male or female between 18 and 65 years of age, inclusive. Female subjects: post menopausal as defined by FSH and LH, or previously documented sterilization. Legally acceptable representatives (relatives/guardians) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are allowing the subject to participate in the study. Moderately increased ICP (ICP>20 mmHG and CPP greater than or equal to 60mmHg) after initial response to =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Major injury (multitrauma) or disease outside the CNS causing significant vital organ- or blood counts dysfunction (eg Disseminated Intravascular Coagulation (DIC), serious hepatic or kidney failure, (Acute Respiratory Distress Syndrome (ARDS) etc.). Subjects who already received specific ICP lowering therapy, other than drainage, before being dosed with JNJ-17299425. Rapid increase of ICP expected to result in death of the subject. Relevant abnormal values for hematology, clinical chemistry or urinalysis at screening. In particular, a significant abnormal hematology profile, or unacceptable bleeding diathesis. Any known significant history or family history of anemia, hemolytic or otherwise, or autoimmune disease. Significant non-brain trauma. On CT scan, compressive hematoma and more than 2 cm midline shift resulting into cranial surgery, or other features that would make the need for surgery unlikely. Any unknown significant history or family history of thrombocytopenia (eg idiopathic thrombocytopenia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether JNJ-17299425 can reduce the increased intracranial pressure (ICP) after traumatic brain injury. The primary pharmacodynamic (PD) parameter is the reduction of ICP; the percentage reduction will be characterized, as well as the absolute reduction, and the reduction below 20 mmHg. The duration of the ICP reduction will also be analyzed. Additionally, the safety, tolerability and maximum safe dose of JNJ-17299425.;Secondary Objective: To determine the effects of JNJ-17299425 on cerebral perfusion pressure (CPP), mean arterial blood pressure (MABP), and clinical scoring assessment. To investigate the pharmacokinetic (PK) profile of JNJ-17299425. To investigate a PK/PD relationship of JNJ-17299425.;Primary end point(s): Pharmacodynamic parameter of ICP. Percentage of subjects with an ICP reduction to below 20 mmHg and the duration of the ICP reduction. Safety and tolerabilility and determination of maximum safe dose of JNJ 17299425. | — |
Countries
Belgium, France
Outcome results
None listed