A Study to Evaluate the Safety and Tolerability of Valproic Acid in Trauma Patients(Part 2)
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|ClinicalTrials.gov Identifier: NCT02872428|
Recruitment Status : Terminated (at request of funding group because of failure to enroll more than one patient)
First Posted : August 19, 2016
Last Update Posted : November 6, 2017
THIS IS THE SECOND PART OF A 2-PART STUDY. The purpose of the first part of this study was to determine the safety and tolerability of ascending doses of valproic acid (also known as Depacon) administered as intravenous infusion (IV) in doses ranging from 15 mg/kg to 250 mg/kg in healthy subjects.
The second part of the study will also be to determine the safety and tolerability of single ascending doses of valproic acid administered as IV in trauma subjects with hemorrhagic shock.
|Condition or disease||Intervention/treatment||Phase|
|Shock,Hemorrhagic Trauma||Drug: Valproic Acid Drug: Isotonic saline solution||Phase 1|
THIS IS THE SECOND PART OF A 2-PART STUDY. Part 1 of the study will be a single center study intended to assess the safety and tolerability of valproic acid dosages at 15 mg/kg, 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, 150 mg/kg 180 mg/kg, 210 mg/kg and 250 mg/kg. Up to 72 healthy subjects (9 dose groups of 8 subjects) will receive single doses of valproic acid or placebo via a 60-min IV infusion in a ratio of 3:1 active drug: placebo. ID: VPA-C-002
Part 2 of the study will be a multi-center, double blind, placebo-controlled study in trauma patients with hemorrhagic shock. The patients will be able to consent themselves, or if unable due to injuries, a Legally Authorized Representative will consent for them. Up to 12 patients (2 dose groups of 6 patients) will receive single doses of valproic acid or placebo via a 60-min IV infusion in a ratio of 2:1 active drug : placebo. The dose levels in Part 2 will be the two highest doses that are demonstrated to have acceptable safety profile based on the review of safety data from Part 1 (130mg/kg and 140mg/kg).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 1, Single Ascending Dose, Double Blind, Placebo Controlled Study to Evaluate the Safety and Tolerability of Valproic Acid in Healthy Volunteers (Part 1) or Trauma Patients(Part 2)|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||September 29, 2017|
|Actual Study Completion Date :||September 29, 2017|
Experimental: Valproic acid (Depacon)
Valproic acid by IV infusion over one hour
Drug: Valproic Acid
By infusion over 1 hour
Other Name: Depacon
Placebo Comparator: Isotonic saline solution
The placebo administered by IV infusion over 1 hour
Drug: Isotonic saline solution
By infusion over 1 hour
- Dose limiting toxicity (DLT) [ Time Frame: As this is a safety study, subjects will be monitored for side-effects beginning immediately after the one hour infusion until the follow-up visit (between 2-6 weeks post infusion) is completed. ]
Dose limiting toxicity (DLT) will be measured by drug-related grade 2 (moderate) or higher
toxicity indicators (excluding fever, chills, nausea or other possible infusion-related effects).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872428
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Hasan Alam, MD||University of Michigan|