Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Abela Pharm

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Severe Head Trauma

Treatments: Drug: AbelaDrug200; Drug: mannitol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00810940

AbelaTBI2

Details and patient eligibility

About

This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis TBI
• GCS 4-8
• Age 16-70

Exclusion criteria

• Multiple trauma resulting in shock
• Bilateral absent pupil response
• Time from injury > 6 hours
• Brain tumor or mass effect secondary to hemorrhage or brain surgery
• Pregnancy
• Confounding condition or injury
• Spinal cord injury
• Sustained high blood pressure or arterial oxygen saturation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Active Comparator group

Description:

Control: Standard treatment for severe head trauma including mannitol

Treatment:

Drug: mannitol

2

Experimental group

Description:

Study drug plus standard treatment

Treatment:

Drug: AbelaDrug200