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| Name | Class |
|---|---|
| National Center for PTSD | FED |
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This open label study will evaluate the safety and efficacy of riluzole in patients with PTSD. Patients will receive riluzole 50mg twice per day orally for 12 weeks as outpatient, with a one month follow up at week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riluzole | Experimental | Riluzole 50 mg orally twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riluzole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered PTSD Scale (CAPS) | The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms. | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Traumatic Stress Disorder Checklist (PCL) | 12 weeks | |
| Clinical Global Impressions Scale | 12 weeks | |
| Montgomery-Asberg Depression Rating Scale (MADRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadi Abdallah, MD | National Center for PTSD / Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Neuroscience Division, National Center for PTSD | West Haven | Connecticut | 06516 | United States |
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| Label | URL |
|---|---|
| National Center for PTSD | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Riluzole Open Label | Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Riluzole Open Label | Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Clinician Administered PTSD Scale (CAPS) | The CAPS is a standardized clinician-rated instrument to assess the presence and severity of PTSD symptoms. The scores range from 0 (minimum) to 80 (mazimum). Higher scores reflect worse symptoms. | 18 participants started the study and 9 participants were randomized into the single arm of the study. However, only 8 participants completed the treatment. Since there was some treatment data collected on the 9th participant, he/she was included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to 12 weeks |
|
8 weeks
The reporting of the adverse events reflects that one participant could have experienced more than one adverse event. For example, one participant experienced both dry mouth and lightheadedness. Similarly, three participants could have experienced chest pain. Thus, it may seem like the number of participants that experienced various adverse events does not match up to the number of participants in the participant flow. We analyzed 9 participants total and recorded their AEs in this section.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riluzole Open Label | Subjects diagnosed with PTSD will receive riluzole, 50 mg taken orally twice daily (BID) for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chadi Abdallah | Yale School of Medicine | 347-987-0717 | chadi.abdallah@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2018 | Mar 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
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| 12 weeks |
| years |
|
| Sex: Female, Male | Indication of whether a participant is male or female | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-Traumatic Stress Disorder Checklist (PCL) | Not Posted | 12 weeks | Participants |
| Secondary | Clinical Global Impressions Scale | Not Posted | 12 weeks | Participants |
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | Not Posted | 12 weeks | Participants |
| Other Pre-specified | Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) | Not Posted | 12 weeks | Participants |
| 0 |
| 9 |
| 0 |
| 9 |
| 7 |
| 9 |
| Dry mouth | General disorders | Non-systematic Assessment |
|
| Altered Taste Sensation | General disorders | Non-systematic Assessment |
|
| Light headedness | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Rhinitis, congestion, sinus pressure, postnasal drip | General disorders | Non-systematic Assessment |
|
| bruxism | General disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| chest pain | General disorders | Non-systematic Assessment |
|
| dry cough | General disorders | Non-systematic Assessment |
|
| urinary urgency | General disorders | Non-systematic Assessment |
|
| edema | General disorders | Non-systematic Assessment |
|
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| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |