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Muscle Relaxant
Cyclobenzaprine for Post-Traumatic Stress Disorder (OASIS Trial)
Worcester, MA
Phase 2
Waitlist Available
Led By Christopher Jones, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years and ≤ 55 years of age
Pain severity in the ED ≥ 4 (0-10 numeric rating scale)
Must not have
Plans for hospital admission
Currently in the acute recovery phase of myocardial infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up min 30, hour 1, 6, 12, day 1, 2, 3, week 1, 2, 3, 5, 6, 8, 11, 12 after mvc
Summary
This trial will test if a medication called TNX-102 SL can help reduce symptoms and behavioral changes in patients who go to the emergency department after a car accident. The study will involve 180 participants
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Who is the study for?
This trial is for individuals who have recently been in a motor vehicle collision and are at high risk of developing acute stress reactions or disorders. Participants will receive treatment shortly after the event and must be willing to undergo assessments over several weeks.Check my eligibility
What is being tested?
The study tests if TNX-102 SL, taken sublingually, can reduce symptoms of acute stress reaction/disorder right after a traumatic event like a car crash. It's compared with a placebo in a double-blind setup where neither doctors nor patients know who gets the real medicine.See study design
What are the potential side effects?
Possible side effects aren't specified here but generally, Cyclobenzaprine may cause drowsiness, dry mouth, fatigue, headache and dizziness. Any adverse events during the trial will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
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My pain level is 4 or higher on a scale of 0 to 10.
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I was admitted to the emergency department within a day after a car accident.
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I expect to go home after my emergency department visit.
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I cannot have children due to surgery or being postmenopausal for over a year.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am scheduled to be admitted to the hospital.
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I am currently recovering from a recent heart attack.
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I am able to make my own medical decisions.
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I have a serious injury, like a major bone break.
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I have been taking more than 20 mg of morphine daily before my injury.
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I do not have active psychosis or thoughts of harming myself or others.
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I am allergic to cyclobenzaprine or ingredients in TNX-102 SL.
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My liver or kidney function is not normal.
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I have a history of urinary issues, glaucoma, eye pressure problems, or an overactive thyroid.
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I have a history of heart rhythm problems or heart failure.
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I am not taking any prohibited medications listed in the trial guidelines.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ min 30, hour 1, 6, 12, day 1, 2, 3, week 1, 2, 3, 5, 6, 8, 11, 12 after mvc
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~min 30, hour 1, 6, 12, day 1, 2, 3, week 1, 2, 3, 5, 6, 8, 11, 12 after mvc
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ASD Score
Secondary study objectives
Change in Depressive Symptoms Score
Change in PTSD Symptoms
Change in Pain Symptom Score
+5 moreSide effects data
From 2017 Phase 3 trial • 180 Patients • NCT0281456520%
Somnolence
7%
Dry mouth
1%
Disruptive mood dysregulation disorder
1%
Sleep disorder
1%
Rhinitis
1%
Dysgeusia
1%
Poor quality sleep
1%
Anxiety
1%
Flatulence
1%
Toothache
1%
Influenza
1%
Dizziness
1%
Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cyclobenzaprine HCl 15 mg
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cyclobenzaprine HClExperimental Treatment1 Intervention
Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.
Group II: PlaceboPlacebo Group1 Intervention
Participants will be instructed to take a half dose (equivalent to 1 tablet, 2.8 mg) of placebo in the ED as part of enrollment procedures. The placebo is the same formulation as active except the Cyclobenzaprine HCl content is replaced by Mannitol to maintain the same tablet weight and dimensions. If the time between the first half dose and the planned bedtime of the participant is less than 6 hours, participants will be instructed to take 1 tablet (half dose) the first night at bedtime. If the time between the first half dose and planned bedtime of the participant is greater than or equal to 6 hours, then participants will be instructed to take a full dose (equivalent to 2 tablets) the first night. Over the following 13 days, all participants will be instructed to take a full dose of the study drug at bedtime. Each participant will receive 29 tablets and take either 28 or 29 tablets total for the duration of study participation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclobenzaprine HCl
2016
Completed Phase 3
~180
Find a Location
Closest Location:University of Kansas Medical Center· Kansas City, KS· 198 miles
Who is running the clinical trial?
Mclean HospitalOTHER
219 Previous Clinical Trials
22,211 Total Patients Enrolled
Cooper University Health CareOTHER
1 Previous Clinical Trials
1,771 Total Patients Enrolled
Tonix Pharmaceuticals, Inc.Industry Sponsor
30 Previous Clinical Trials
4,784 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,580 Previous Clinical Trials
4,326,896 Total Patients Enrolled
United States Department of DefenseFED
931 Previous Clinical Trials
335,885 Total Patients Enrolled
Christopher Jones, MDPrincipal InvestigatorCooper University Health Care
2 Previous Clinical Trials
170 Total Patients Enrolled
Samuel McLean, MDPrincipal InvestigatorUniversity of North Carollina at Chapel Hill