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Trial record 31 of 47 for:    CYCLOBENZAPRINE

12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients

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ClinicalTrials.gov Identifier: NCT03110575
Recruitment Status : Terminated (Stopped early due to inadequate separation on primary efficacy endpoint in the lead-in HONOR study, TNX-CY-P301)
First Posted : April 12, 2017
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Brief Summary:
This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study.

Condition or disease Intervention/treatment Phase
PTSD Drug: TNX-102 SL Phase 3

Detailed Description:

The study will consist of 5 study visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same visit as the last visit on double-blind treatment), a phone visit after 2 weeks of treatment, and in-clinic visits after 4, 8, and 12 weeks of treatment.

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.

The secondary objective of the study is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12-Week Open-Label Extension Study to Evaluate TNX-102 SL Taken Daily at Bedtime in Patients With PTSD
Actual Study Start Date : June 20, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TNX-102 SL
2 x TNX-102 SL, 2.8 mg tablets taken daily at bedtime for 12 weeks
Drug: TNX-102 SL
2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
Other Name: cyclobenzaprine HCl




Primary Outcome Measures :
  1. Evaluate the incidence of adverse events of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study [ Time Frame: 12 weeks ]
    Adverse events will be coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA) and will be summarized overall and by preferred term and system organ class. Serious AEs and AEs leading to discontinuation of study drug will also be summarized.


Secondary Outcome Measures :
  1. Evaluate the change from both baselines in the Total CAPS-5 score of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study [ Time Frame: Week 0, 12 ]
    The CAPS-5 symptom severity 1-week recall version will be administered by qualified and trained clinicians.

  2. Evaluate the proportion of patients with a CGI-I score of "very much improved" or "much improved" of TNX-102 SL tablets taken daily at bedtime over an additional 12 weeks in patients with PTSD who have completed a double-blinded lead-in study [ Time Frame: Week 4, 8, 12 ]
    The CGI-I is a clinician-rated scale designed to assess overall clinical improvement (change) since baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has completed the final treatment study visit of the lead-in study and remained compliant with the lead-in protocol and study treatment.
  • The patient has provided written informed consent to participate in this extension protocol.
  • Female patients of childbearing potential continue to agree to practice one of the medically acceptable methods of birth control detailed in the lead-in study.

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

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): NCT03110575


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Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Premier Research Group plc
Investigators
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Study Director: Denise Bedoya Premier Research Group plc

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03110575     History of Changes
Other Study ID Numbers: TNX-CY-P303
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tonix Pharmaceuticals, Inc.:
TNX-102 SL
Bedtime
Sublingual
3-month
Safety
Efficacy
PTSD
Additional relevant MeSH terms:
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Cyclobenzaprine
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants