Post-traumatic Stress DisorderPhase 1NCT02234687
A mGlu2/3 Agonist in the Treatment of PTSD
A Phase 1 study testing Pomaglumetad Methionil 160mg and Pomaglumetad Methionil 40mg in people with Post-traumatic Stress Disorder, run by NYU Langone Health.
Trial summary
In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Pomaglumetad Methionil 160mg and Pomaglumetad Methionil 40mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to 11 Sep 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 60 years of age, any race
- Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
- Able to provide written informed consent
Who cannot join
- Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia, schizoaffective disorder, bipolar disorder
- History of moderate or severe traumatic brain injury (TBI) with loss of consciousness
- Lifetime history of seizure disorder
- Current diagnosis of obsessive-compulsive disorder (OCD)
- Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder
- Alcohol or drug abuse in the past 90 days, or dependence in the past year.
Show all 15Show fewer
- Individuals with a cumulative lifetime history of intravenous substance abuse longer than 1 year.
- Severe dissociation, defined as a Clinician Administered Dissociative States Scale (CADSS) score greater than 60 at baseline
- Patients with creatinine clearance <60 milliliters (mL)/min (moderate renal impairment)
- Current pregnancy or breast feeding; medical conditions that could interfere with correct interpretation of study data, i.e., individuals with the following medical conditions will be excluded: cancer in the past year, stroke, heart attack, angina, neurological disease (multiple sclerosis, epilepsy, Parkinson's disease), central nervous system (CNS) lesions including TBI with loss of consciousness, dementing illness, and/or liver or kidney disease. Patients with QT interval >450 msec (males) and >470 msec (females).
- Participants who have started new medication regimen for PTSD within 3 months prior to study start and subjects taking fluoxetine
- Current suicidality defined by emergent Columbia Suicide Severity Rating Scale (CSSRS)-defined suicidal behavior, a suicidal ideation score of 5 (indicating active suicidal ideation with specific plan and some level of intent) or 4 (indicating active suicidal ideation with some intent to act, without specific plan) on the CSSRS or in the absence of a CSSRS suicidal ideation score of 5 or 4 or CSSRS-defined suicidal behavior, if the investigator determines the patient to have a significant short-term risk for a suicide attempt.
- Individuals with active suicidal risk, active self-mutilation or aggressive behavior with threatening behavior toward others within the past year, as judged by the Principal Investigator
- Pregnant or lactating women
- Legal and Financial: Current legal proceedings resulting from the traumatic events. People whose continued receipt of financial benefits is contingent upon maintaining PTSD symptoms or who are waiting for a decision concerning the receipt of financial benefits based upon PTSD symptoms
About this study
In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in adults with post-traumatic stress disorder (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg vs placebo in a 1:1:1 ratio).
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Pomaglumetad Methionil 160mg, Pomaglumetad Methionil 40mg, Placebo
- Keywords
- post-traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomaglumetad Methionil 160mgDrug
Also called LY2140023
Pomaglumetad Methionil 160mg, one dose, one time
Pomaglumetad Methionil 40mgDrug
Also called LY2140023
Pomaglumetad Methionil 40mg, one dose, one time
PlaceboDrug
Placebo, one dose, one time
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, one dose Receives: Drug: Placebo |
| Pomaglumetad Methionil 40mg | Experimental | Pomaglumetad Methionil 40mg, one dose, one time Receives: Drug: Pomaglumetad Methionil 40mg |
| Pomaglumetad Methionil 160mg | Experimental | Pomaglumetad Methionil 160mg, one dose, one time Receives: Drug: Pomaglumetad Methionil 160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil
To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion11 Feb 2016
- Study completion11 Sep 2016
Why it stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Marmar, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234687
- Sponsor's protocol ID
- 13-00609
- Status last verified
- Mar 2018
- First submitted
- 3 Sep 2014
- Last updated
- 2 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A mGlu2/3 Agonist in the Treatment of PTSD
- ClinicalTrials.gov ID
- NCT02234687
- Acronym / sponsor ID
- 13-00609
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- post-traumatic stress disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 11 Sep 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we propose to employ a randomized, double-blind, placebo-controlled, outpatient clinical trial to test the efficacy, safety, and tolerability of a 160 mg and 40 mg challenge of the mGlu2/3 agonist pomaglumetad methionil relative to placebo in modulating fear-potentiated startle response and behavior in adults with post-traumatic stress disorder (PTSD) (N=30). Each participant will receive a single dose of the study drug (40 mg vs 160 mg vs placebo in a 1:1:1 ratio).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, one dose |
| Pomaglumetad Methionil 40mg | Experimental | Drug: Pomaglumetad Methionil 40mgPomaglumetad Methionil 40mg, one dose, one time |
| Pomaglumetad Methionil 160mg | Experimental | Drug: Pomaglumetad Methionil 160mgPomaglumetad Methionil 160mg, one dose, one time |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men and women between 18 and 60 years of age, any race
- Primary, current Axis I diagnosis of post traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders - IV (DSM-IV) criteria
- Able to provide written informed consent
Key exclusion criteria (15 listed)
- Past or current presence of psychotic symptoms, or diagnosis of a lifetime psychotic disorder including schizophrenia, schizoaffective disorder, bipolar disorder
- History of moderate or severe traumatic brain injury (TBI) with loss of consciousness
- Lifetime history of seizure disorder
- Current diagnosis of obsessive-compulsive disorder (OCD)
- Current diagnosis of bulimia nervosa or anorexia nervosa; or substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomaglumetad Methionil 160mgAlso: LY2140023Pomaglumetad Methionil 160mg, one dose, one time | Drug | Pomaglumetad Methionil 160mg |
| Pomaglumetad Methionil 40mgAlso: LY2140023Pomaglumetad Methionil 40mg, one dose, one time | Drug | Pomaglumetad Methionil 40mg |
| PlaceboPlacebo, one dose, one time | Drug | Placebo |
Primary outcome
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil
Time frame: 6 months
To evaluate the effect of 160mg and 40mg challenge of the mGlu2/3 receptor agonist pomaglumetad methionil relative to placebo in mitigating fear-potentiated startle using the neutral-predictable-unpredictable fear-potentiated startle paradigm in adults with post-traumatic stress disorder (PTSD). The primary index of unpredictable fear will be the difference score between startle magnitude in safe and unpredictable conditions in the absence of the cue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post-traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Marmar, MD principal investigator
NYU School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pomaglumetad Methionil 160mg and Pomaglumetad Methionil 40mg in people with Post-traumatic Stress Disorder, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Evaluate the Effect of 160mg and 40mg of Pomaglumetad Methionil (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.