Allopregnanolone for the Treatment of Traumatic Brain Injury

NCT01673828 | Completed Phase 2 Results DMC

• 2 other identifiers: 273147DR081314
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.

Conditions

Traumatic Brain Injury; Posttraumatic Epilepsy

Keywords

Brain Injuries; Pregnanolone; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Extended Glasgow Outcome Scale (GOS-E) Score

  GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.

  6 months after injury

Study Arms (2)

Allopregnanolone

EXPERIMENTAL

Allopregnanolone injection (intravenous solution) continuous infusion for 5 days

Drug: Allopregnanolone injection

Placebo

PLACEBO COMPARATOR

Placebo injection (intravenous solution) continuous infusion for 5 days

Drug: Placebo injection

Interventions

Allopregnanolone injection DRUG

Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium

Also known as: 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)

Allopregnanolone

Placebo injection DRUG

Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium

Also known as: Product P (placebo)

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English or Spanish speaking person
• Moderate to severe closed or blunt traumatic brain injury \[post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12\]
• Less than 8 hours from injury to study initiation
• Able to participate for the full term of the study

You may not qualify if:

• Subjects with life expectancy of less than 24 hours
• Isolated epidural hematoma
• Hypoxia (pulse oximetry saturation ≤90% for 15 or more minutes before enrollment)
• Hypotension (systolic blood pressure ≤90 mm Hg on 2 or more reliable measurements before enrollment)
• Cardiopulmonary arrest prior to randomization
• Spinal cord injury with motor deficits
• Bilateral non-reactive pupils with Glasgow Coma Scale 3
• Body weight \>120 kg
• Pregnancy
• Active breast or reproductive organ cancer
• Allergy to progesterone
• History of thromboembolic events
• Receipt of activated Factor VII before enrollment
• Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance \<50 ml/min)
• Prisoner/ward of the state

Sponsors & Collaborators

• Michael A. Rogawski, MD, PhD: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Epilepsy, Post-Traumatic; Brain Injuries; Epilepsy

Interventions

Pregnanolone

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

One subject receiving active treatment died during initial hospitalization; the death was not considered related to the study treatment. Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Dr. Michael Rogawski
• Organization: Department of Neurology, School of Medicine, University of California, Davis

rogawski@ucdavis.edu

916-734-6285

Study Officials

• Michael A Rogawski, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• JoAnne E Natale, MD, PhD

  University of California, Davis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Invstigator

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 28, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2016
• Last Updated: June 28, 2017
• Results First Posted: June 28, 2017

Record last verified: 2017-05

Locations

US (1)