NCT01143064 (SyNAPSe) is a Phase 3 clinical trial of Progesterone in Brain Injuries, sponsored by BHR Pharma, LLC.

Who is sponsoring NCT01143064?

NCT01143064 is sponsored by BHR Pharma, LLC.

What drugs are being tested in NCT01143064?

Interventions in NCT01143064: Progesterone, Lipid emulsion without progesterone.

What condition does NCT01143064 study?

NCT01143064 studies Brain Injuries.

Is NCT01143064 still recruiting?

NCT01143064 is currently completed. Last updated 5 September 2024.

Are results published for NCT01143064?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-05 · How we verify

NCT01143064: SyNAPSe

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury

Completed Phase 3 Results posted Last updated 5 September 2024

What this trial tests

Phase 3 trial testing Progesterone in Brain Injuries in 1,195 participants. Completed in 1 March 2014.

Timeline

1 June 2010

Primary endpoint
1 March 2014

1 March 2014

Quick facts

Lead sponsor	BHR Pharma, LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	1,195
Start date	1 June 2010
Primary completion	1 March 2014
Estimated completion	1 March 2014
Sites	156 locations across United States, Argentina, Austria, Belgium, China, Czechia, Finland, France

Drugs / interventions tested

Progesterone (Progesterone plus HCG) — full drug profile →
Lipid emulsion without progesterone — full drug profile →

Conditions studied

Brain Injuries — all drugs for Brain Injuries →

Sponsor

BHR Pharma, LLC — full company profile →

Who can join

Adults 16 to 70, any sex, with Brain Injuries. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Glasgow Outcome Scale (GOS)
Time frame: 6 months
The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.

Sponsor's own description

The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

A clinical trial of progesterone for severe traumatic brain injury.
Skolnick BE, Maas AI, Narayan RK, van der Hoop RG, et al · · 2014 · cited 336× · PMID 25493978 · DOI 10.1056/nejmoa1411090
Pharmacotherapy of traumatic brain injury: state of the science and the road forward: report of the Department of Defense Neurotrauma Pharmacology Workgroup.
Diaz-Arrastia R, Kochanek PM, Bergold P, Kenney K, et al · · 2014 · cited 205× · PMID 23968241 · DOI 10.1089/neu.2013.3019
Progesterone treatment normalizes the levels of cell proliferation and cell death in the dentate gyrus of the hippocampus after traumatic brain injury.
Barha CK, Ishrat T, Epp JR, Galea LA, et al · · 2011 · cited 90× · PMID 21684276 · DOI 10.1016/j.expneurol.2011.05.016
The Importance of Therapeutic Time Window in the Treatment of Traumatic Brain Injury.
Mohamadpour M, Whitney K, Bergold PJ. · · 2019 · cited 87× · PMID 30728762 · DOI 10.3389/fnins.2019.00007
Progesterone in experimental permanent stroke: a dose-response and therapeutic time-window study.
Wali B, Ishrat T, Won S, Stein DG, et al · · 2014 · cited 62× · PMID 24374329 · DOI 10.1093/brain/awt319
Management of Traumatic Brain Injury: From Present to Future.
Crupi R, Cordaro M, Cuzzocrea S, Impellizzeri D. · · 2020 · cited 58× · PMID 32252390 · DOI 10.3390/antiox9040297
The neuroprotective effects of progesterone on traumatic brain injury: current status and future prospects.
Wei J, Xiao GM. · · 2013 · cited 54× · PMID 24241345 · DOI 10.1038/aps.2013.160
Progesterone treatment shows benefit in a pediatric model of moderate to severe bilateral brain injury.
Geddes RI, Sribnick EA, Sayeed I, Stein DG. · · 2014 · cited 34× · PMID 24489882 · DOI 10.1371/journal.pone.0087252

Verify or expand the search:

Other trials of Progesterone

Trials testing the same drug.

NCT07372495 — Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix · NA · not yet recruiting
NCT06631547 — Effect of Progesterone Administration on Severely Head Injured Patients · Phase 1 · not yet recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
NCT06928844 — Role of Low Dose Injectable Progesterone in Triggering Ovulation · NA · recruiting

Other recruiting trials for Brain Injuries

Currently open trials in the same condition.

NCT06607523 — The Gut-Brain Axis During Neurorehabilitation; Prebiotic Treatment to Alter the Gut Microbiome and Neurologic Symptoms · NA · recruiting
NCT06873477 — Evaluation of Patients Affected by Traumatic and Hypoxic-ischemic Brain Injury · recruiting
NCT06511804 — Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Pa · recruiting
NCT06863025 — Effects of Neurofeedback Training on Attentional Deficits in Patients With Acquired Brain Injury · NA · active not recruiting
NCT06571032 — Electroencephalography in the Management of Neuroelectric Stimulation in Patients With Severe Traumatic Brain Injuries · recruiting

Other BHR Pharma, LLC trials

Trials by the same sponsor.

NCT03199963 — Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue · Phase 3 · terminated
NCT03202186 — Study of Progesterone in Treatment of Vasomotor Symptoms · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01143064 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BHR Pharma, LLC
Last refreshed: 5 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01143064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing