Startle ResponsePhase 1NCT03181763
Evaluation of MDMA on Startle Response
A Phase 1 study testing Midomafetamine and Acoustic startle in people with Startle Response, run by Resilient Pharmaceuticals at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants. The main question it aims to answer is: Does MDMA impact participant's performance on a startle test? Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Startle Response
- What is being tested?
- Midomafetamine and Acoustic startle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2017to 1 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Persons aged 21 to 55.
- Ability to visually read and understand English language.
- Live within in metro Atlanta area
- Previously used MDMA in a recreational or research setting
- If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male.
- (For sub-study measuring serum oxytocin) Willing to have periodic blood draws
Who cannot join
- Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study.
- Are abusing illegal drugs.
- Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers
- Are not able to give adequate informed consent.
- Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram.
- Currently pregnant or breast-feeding.
- History of acute angle glaucoma.
- Hearing impairment as assessed by audiometer; unable to detect tones below 40 dB in right or left ear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response
The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants.
The main question it aims to answer is: Does MDMA impact participant's performance on a startle test?
Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo.
Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.
Read the detailed description
This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response.
This study will enroll healthy participants. At Visit 1, all participants will undergo a 1-hour startle test. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the eye. While watching the computer monitor, the participant will also experience several brief blasts of air directed at the throat.
At Visit 2 (24 hours later), participants will be randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo another startle test. Participants enrolled in the study who agree to do this will have their blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to condition, and the decision will happen before randomization to either condition. Blood will be drawn before MDMA or placebo administration, and eight times afterwards.The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience.
At Visit 3, participants will return for a final startle test and recall task. Sleep will be measured via self-report and Fitbit during study participation.
- Conditions
- Startle Response
- Being tested
- Placebo, Midomafetamine, Acoustic startle
- Keywords
- MDMA, Startle response, sleep, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called inactive placebo, lactose
Participants will receive inactive placebo on their second visit.
MidomafetamineDrug
Also called 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HCl
Participants will receive 100 mg midomafetamine HCl on their second visit
Acoustic startleBehavioural
Also called startle test
Startle assessment
| Study group | Role | What they receive |
|---|---|---|
| 100 mg MDMA HCl | Experimental | Participants receive 100 mg MDMA HCl on their second visit Receives: Drug: Midomafetamine; Behavioral: Acoustic startle |
| Placebo | Placebo comparator | Participants receive inactive placebo on their second visit Receives: Drug: Placebo; Behavioral: Acoustic startle |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG of right orbicularis oculi muscle
Description: Measure of startle response to noise after fear extinction training
Measured: Four days post-enrollment
Secondary outcomes (41)
Systolic blood pressure pre-drug
Systolic blood pressure measured prior to administration of MDMA or placebo
Measured: 5 minutes pre-drug
Systolic blood pressure 45 min post-drug
Systolic blood pressure measured 45 minutes after MDMA or placebo administration
Measured: 45 minutes post-drug
Systolic blood pressure 1 h 15 min post-drug
Systolic blood pressure measured 1 hour 15 minutes after MDMA or placebo administration
Measured: 1 hour 15 minutes post drug
Systolic blood pressure 1 h 45 min post-drug
Systolic blood pressure measured 1 hour 45 minutes after MDMA or placebo administration
Measured: 1 hour 45 minutes post drug
Systolic blood pressure 3 h post-drug
Systolic blood pressure measured 3 hours after MDMA or placebo administration
Measured: 3 hours post-drug
Systolic blood pressure 4 h post-drug
Systolic blood pressure measured 4 hours after MDMA or placebo administration
Measured: 4 hours post-drug
Systolic blood pressure 5 h post-drug
Systolic blood pressure measured 5 hours after MDMA or placebo administration
Measured: 5 hours post-drug
Systolic blood pressure 6 h post-drug
Systolic blood pressure measured 6 hours after MDMA or placebo administration
Measured: 6 hours post-drug
Diastolic blood pressure pre-drug
Diastolic blood pressure measured prior to MDMA or placebo administration
Measured: 5 minutes pre-drug
Diastolic blood pressure 45 min post-drug
Diastolic blood pressure measured 45 minutes after MDMA or placebo administration
Measured: 45 minutes post-drug
Diastolic blood pressure 1 h 15 min post-drug
Diastolic blood pressure measured 1 h 15 minutes after MDMA or placebo administration
Measured: 1 hour 15 minutes post-drug
Diastolic blood pressure 1 h 45 min post-drug
Diastolic blood pressure measured 1 h 45 minutes after MDMA or placebo administration
Measured: 1 hour 45 minutes post drug
Diastolic blood pressure 3 h post-drug
Diastolic blood pressure measured 3 hours after MDMA or placebo administration
Measured: 3 hours post-drug
Diastolic blood pressure 4 hours post-drug
Diastolic blood pressure measured 4 hours after MDMA or placebo administration
Measured: 4 hours post-drug
Diastolic blood pressure 5 hours post-drug
Diastolic blood pressure measured 5 hours after MDMA or placebo administration
Measured: 5 hours post-drug
Diastolic blood pressure 6 hours post-drug
Diastolic blood pressure measured 6 hours after MDMA or placebo administration
Measured: 6 hours post-drug
Pulse pre-drug
Pulse (assessing heart rate) measured prior to MDMA or placebo administration
Measured: 5 minutes pre-drug
Pulse 45 min post-drug
Pulse (assessing heart rate) measured 45 min after MDMA or placebo administration
Measured: 45 minutes post-drug
Pulse 1 h 15 min post-drug
Pulse (assessing heart rate) measured 1 hour 15 min after MDMA or placebo administration
Measured: 1 hour 15 minutes post-drug
Pulse 1 h 45 min post-drug
Pulse (assessing heart rate) measured 1 hour 45 min after MDMA or placebo administration
Measured: 1 hour 45 minutes post-drug
Pulse 3 h post-drug
Pulse (assessing heart rate) measured 3 hours after MDMA or placebo administration
Measured: 3 hours post-drug
Pulse 4 h post-drug
Pulse (assessing heart rate) measured 4 hours after MDMA or placebo administration
Measured: 4 hours post-drug
Pulse 5 h post-drug
Pulse (assessing heart rate) measured 5 hours after MDMA or placebo administration
Measured: 5 hours post-drug
Pulse 6 h post-drug
Pulse (assessing heart rate) measured 6 hours after MDMA or placebo administration
Measured: 6 hours post-drug
Body temperature pre-drug
Body temperature measured before MDMA or placebo administration
Measured: 5 minutes pre-drug
Body temperature 45 minutes post-drug
Body temperature measured 45 minutes after MDMA or placebo administration
Measured: 45 minutes post-drug
Body temperature 1 h 15 minutes post-drug
Body temperature measured 1 hour 15 minutes after MDMA or placebo administration
Measured: 1 hour 15 minutes post-drug
Body temperature 1 h 45 minutes post-drug
Body temperature measured 1 hour 45 minutes after MDMA or placebo administration
Measured: 1 hour 45 minutes post-drug
Body temperature 3 hours post-drug
Body temperature measured 3 hours after MDMA or placebo administration
Measured: 3 hours post-drug
Body temperature 4 hours post-drug
Body temperature measured 4 hours after MDMA or placebo administration
Measured: 4 hours post-drug
Body temperature 5 hours post-drug
Body temperature measured 5 hours after MDMA or placebo administration
Measured: 5 hours post-drug
Body temperature 6 hours post-drug
Body temperature measured 6 hours after MDMA or placebo administration
Measured: 6 hours post-drug
Plasma oxytocin (OT) levels predrug
In people who agree to it, blood collected to assess levels of oxytocin prior to MDMA or placebo administration on day of drug administration
Measured: 5 min prior to drug administration
Plasma oxytocin (OT) levels 5 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 5 minutes after MDMA or placebo administration
Measured: 5 min post-drug administration
Plasma oxytocin (OT) levels 20 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 20 minutes after MDMA or placebo administration
Measured: 20 min post-drug administration
Plasma oxytocin (OT) levels 95 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 95 minutes (approximately 1.5 h) after MDMA or placebo administration
Measured: 95 min post-drug administration
Plasma oxytocin (OT) levels 110 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 110 minutes after MDMA or placebo administration
Measured: 110 min post-drug administration
Plasma oxytocin (OT) levels 185 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 185 minutes after MDMA or placebo administration
Measured: 185 min post-drug administration
Plasma oxytocin (OT) levels 200 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 200 minutes after MDMA or placebo administration
Measured: 200 min post-drug administration
Plasma oxytocin (OT) levels 240 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 240 minutes after MDMA or placebo administration
Measured: 240 min post-drug administration
Plasma oxytocin (OT) levels 300 min post-drug
In people who agree to it, blood collected to assess levels of oxytocin approximately 300 minutes after MDMA or placebo administration
Measured: 300 min post-drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start14 Mar 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Startle ResponseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilient Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Rothbaum, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181763
- Sponsor's protocol ID
- MPVA-4
- Status last verified
- Feb 2025
- First submitted
- 5 Jun 2017
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maples-Keller JL, Norrholm SD, Burton M, Reiff C, Coghlan C, Jovanovic T, Yasinski C, Jarboe K, Rakofsky J, Rauch S, Dunlop BW, Rothbaum BO. A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults. J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 2022 Feb 15.
PubMed 35166140
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 3,4-methylenedioxymethamphetamine (MDMA) on Startle Response
- ClinicalTrials.gov ID
- NCT03181763
- Acronym / sponsor ID
- MPVA-4
- Conditions
- Startle Response
- Keywords
- MDMA, Startle response, sleep, Oxytocin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Resilient PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if MDMA impacts startle response in healthy participants.
The main question it aims to answer is: Does MDMA impact participant's performance on a startle test?
Researchers will compare healthy volunteers who have taken MDMA to those who have taken placebo.
Participants will first undergo a 1-hour startle test. The next day, they will be randomized to receive either MDMA or placebo followed by another startle test and vitals signs and blood measurements. Participants will return the next day for a final startle test. Their sleep will be tracked by a Fitbit device.
Detailed description
This is a randomized, blinded, placebo-controlled Phase 1 study that aims to evaluate the impact of 3,4-methylenedioxymethamphetamine (MDMA) on startle response.
This study will enroll healthy participants. At Visit 1, all participants will undergo a 1-hour startle test. Acoustic startle will be measured through assessing eye-blink response from the orbicularis oculi muscles in response to a 106 dB noise, using sensors under the eye. While watching the computer monitor, the participant will also experience several brief blasts of air directed at the throat.
At Visit 2 (24 hours later), participants will be randomized to receive 100 mg of MDMA or inactive placebo, after which they will undergo another startle test. Participants enrolled in the study who agree to do this will have their blood drawn to measure levels of oxytocin, and possibly other hormones or proteins, such as cortisol or brain-derived neurotrophic factor (BDNF). Measuring oxytocin will be blind to condition, and the decision will happen before randomization to either condition. Blood will be drawn before MDMA or placebo administration, and eight times afterwards.The researchers will measure pulse, blood pressure and temperature once before and six times after receiving MDMA or placebo, and study participants will complete a questionnaire about their experience.
At Visit 3, participants will return for a final startle test and recall task. Sleep will be measured via self-report and Fitbit during study participation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Blinded, placebo between group; all participants undergo fear conditioning, with half randomized to receive 100 mg MDMA and half receiving inactive placebo
| Arm | Type | Receives |
|---|---|---|
| 100 mg MDMA HCl | Experimental | Drug: Midomafetamine, Behavioral: Acoustic startleParticipants receive 100 mg MDMA HCl on their second visit |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Acoustic startleParticipants receive inactive placebo on their second visit |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Persons aged 21 to 55.
- Ability to visually read and understand English language.
- Live within in metro Atlanta area
- Previously used MDMA in a recreational or research setting
- If a person is of childbearing potential (able to bear children), they must have a negative pregnancy test at study entry and prior to the Experimental Session. They must agree to use adequate birth control through 10 days after the last dose of MDMA. Adequate birth control methods include intrauterine device (IUD), injected or implanted hormonal methods, abstinence, oral hormones plus a barrier contraception or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom). Not of childbearing potential is defined as permanent sterilization, postmenopausal, or male.
Key exclusion criteria (8 listed)
- Upon review of medical or psychiatric history, have any current or past diagnosis that would be considered a risk to participating in the study.
- Are abusing illegal drugs.
- Current use of any psychoactive medications, including antidepressants, mood stabilizers, sedatives, stimulants, antipsychotics, anxiolytics, or beta-blockers
- Are not able to give adequate informed consent.
- Uncontrolled hypertension, or clinically significant cardiac arrhythmia, as detected by electrocardiogram.
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 |
|---|---|---|
| PlaceboAlso: inactive placebo, lactoseParticipants will receive inactive placebo on their second visit. | Drug | Placebo |
| MidomafetamineAlso: 3,4-methylenedioxymethamphetamine, MDMA, midomafetamine HClParticipants will receive 100 mg midomafetamine HCl on their second visit | Drug | 100 mg MDMA HCl |
| Acoustic startleAlso: startle testStartle assessment | Behavioural | 100 mg MDMA HCl, Placebo |
Primary outcome
EMG of right orbicularis oculi muscle
Time frame: Four days post-enrollment
Description: Measure of startle response to noise after fear extinction training
41 secondary outcomes
Systolic blood pressure pre-drug
Time frame: 5 minutes pre-drug
Systolic blood pressure 45 min post-drug
Time frame: 45 minutes post-drug
Systolic blood pressure 1 h 15 min post-drug
Time frame: 1 hour 15 minutes post drug
Systolic blood pressure 1 h 45 min post-drug
Time frame: 1 hour 45 minutes post drug
Systolic blood pressure 3 h post-drug
Time frame: 3 hours post-drug
Systolic blood pressure 4 h post-drug
Time frame: 4 hours post-drug
Systolic blood pressure 5 h post-drug
Time frame: 5 hours post-drug
Systolic blood pressure 6 h post-drug
Time frame: 6 hours post-drug
Diastolic blood pressure pre-drug
Time frame: 5 minutes pre-drug
Diastolic blood pressure 45 min post-drug
Time frame: 45 minutes post-drug
Diastolic blood pressure 1 h 15 min post-drug
Time frame: 1 hour 15 minutes post-drug
Diastolic blood pressure 1 h 45 min post-drug
Time frame: 1 hour 45 minutes post drug
Diastolic blood pressure 3 h post-drug
Time frame: 3 hours post-drug
Diastolic blood pressure 4 hours post-drug
Time frame: 4 hours post-drug
Diastolic blood pressure 5 hours post-drug
Time frame: 5 hours post-drug
Diastolic blood pressure 6 hours post-drug
Time frame: 6 hours post-drug
Pulse pre-drug
Time frame: 5 minutes pre-drug
Pulse 45 min post-drug
Time frame: 45 minutes post-drug
Pulse 1 h 15 min post-drug
Time frame: 1 hour 15 minutes post-drug
Pulse 1 h 45 min post-drug
Time frame: 1 hour 45 minutes post-drug
Pulse 3 h post-drug
Time frame: 3 hours post-drug
Pulse 4 h post-drug
Time frame: 4 hours post-drug
Pulse 5 h post-drug
Time frame: 5 hours post-drug
Pulse 6 h post-drug
Time frame: 6 hours post-drug
Body temperature pre-drug
Time frame: 5 minutes pre-drug
Body temperature 45 minutes post-drug
Time frame: 45 minutes post-drug
Body temperature 1 h 15 minutes post-drug
Time frame: 1 hour 15 minutes post-drug
Body temperature 1 h 45 minutes post-drug
Time frame: 1 hour 45 minutes post-drug
Body temperature 3 hours post-drug
Time frame: 3 hours post-drug
Body temperature 4 hours post-drug
Time frame: 4 hours post-drug
Body temperature 5 hours post-drug
Time frame: 5 hours post-drug
Body temperature 6 hours post-drug
Time frame: 6 hours post-drug
Plasma oxytocin (OT) levels predrug
Time frame: 5 min prior to drug administration
Plasma oxytocin (OT) levels 5 min post-drug
Time frame: 5 min post-drug administration
Plasma oxytocin (OT) levels 20 min post-drug
Time frame: 20 min post-drug administration
Plasma oxytocin (OT) levels 95 min post-drug
Time frame: 95 min post-drug administration
Plasma oxytocin (OT) levels 110 min post-drug
Time frame: 110 min post-drug administration
Plasma oxytocin (OT) levels 185 min post-drug
Time frame: 185 min post-drug administration
Plasma oxytocin (OT) levels 200 min post-drug
Time frame: 200 min post-drug administration
Plasma oxytocin (OT) levels 240 min post-drug
Time frame: 240 min post-drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 35166140Maples-Keller JL, Norrholm SD, Burton M, Reiff C, Coghlan C, Jovanovic T, Yasinski C, Jarboe K, Rakofsky J, Rauch S, Dunlop BW, Rothbaum BO. A randomized controlled trial of 3,4-methylenedioxymethamphetamine (MDMA) and fear extinction retention in healthy adults. J Psychopharmacol. 2022 Mar;36(3):368-377. doi: 10.1177/02698811211069124. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
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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.
Barbara Rothbaum principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midomafetamine and Acoustic startle in people with Startle Response, run by Resilient Pharmaceuticals at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EMG of right orbicularis oculi muscle (time frame: Four days post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03181763, which also lists 1 linked publication.
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 4 Mar 2025.