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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and min 30, hour 1, 6, 12, day 1, 2, 3, week 1, 2, 3, 5, 6, 8, 11, 12 after mvc for reporting.

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 more

Side effects data

From 2017 Phase 3 trial • 180 Patients • NCT02814565

20%

Somnolence

Dry mouth

Disruptive mood dysregulation disorder

Sleep disorder

Rhinitis

Dysgeusia

Poor quality sleep

Anxiety

Flatulence

Toothache

Influenza

Dizziness

Tachycardia

100%

80%

60%

40%

20%

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

0 / 16Eligibility criteria met