CompletedNCT02431806Updated Sep 7, 2020Results posted

Safety and Efficacy of Levomilnacipran ER in Adolescent Participants With Major Depressive Disorder

A Phase 3 interventional study of Placebo and Levomilnacipran in Major Depressive Disorder, sponsored by Forest Laboratories. Completed at 49 sites in 2 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-09-07.

Sponsored by Forest Laboratories (part of AbbVie) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 552
Allocation: Randomized
Ages: 12 Years to 17 Years
Sex: All

Study summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran ER relative to placebo in adolescent outpatients (12-17 years) with Major Depressive Disorder (MDD). In addition, the study is designed to obtain pharmacokinetics (PK) data to guide dose selection for future pediatric studies of levomilnacipran.

Read the detailed description

Study LVM-MD-11 is a randomized, double-blind, placebo- and active-controlled, parallel group, fixed-dose study in adolescent patients, ages 12-17 years. The study will be approximately 10 weeks in duration:

1-week screening/washout period
8-week double-blind treatment period
1-week double-blind down-taper period

Participants who meet the eligibility criteria at Visit 2 (Baseline) will be randomized to 1 of 4 treatment groups: placebo, levomilnacipran 40 mg/day, levomilnacipran 80 mg/day, or fluoxetine 20 mg/day.

Conditions studied

Major Depressive Disorder

Browse trials for

Depressive Disorder, Major 3,041

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's enrollment of 552 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

First submitted before Forest Laboratories became part of AbbVie.

Browse Forest Laboratories studies →All AbbVie studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

Male or female outpatients;12-17 years of age
Meet , Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and (ECG) normal or not

Key Psychiatric Exclusion Criteria:

DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

Allergy, intolerance, or to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests (AST) and/or alanine aminotransferase (ALT) > 2X the (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol

Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 552 participants (actual)

Study arms

Placebo comparator
Placebo
Participants received 2 dose matched over-encapsulated placebo capsules, once daily, orally during the Double-blind Treatment Period up to 8 weeks followed by a 1 week Taper-down Period if applicable as determined by the investigator.
Drug: Placebo
Experimental
Levomilnacipran 40 mg
Participants received over-encapsulated levomilnacipran extended release (ER) 40 mg/day capsules orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Days 3-7 and 40 mg/day on Week 2 through Week 8 during the Double-Blind Treatment Period, followed by a 1-week Double-Blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Drug: Levomilnacipran
Experimental
Levomilnacipran 80 mg
Participants received over-encapsulated levomilnacipran ER two 40 mg/day capsules (80 mg/day) orally starting at a dose of 10 mg/day on Day 1-2, 20 mg/day on Day 3-4, 40 mg/day on Day 5-7 and 80 mg/day on Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule the first week and during the taper-down period to maintain the blind.
Drug: Levomilnacipran
Active comparator
Fluoxetine 20 mg
Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.
Drug: Fluoxetine

Interventions

DrugPlacebo
Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
DrugLevomilnacipran
Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
Also known as: Fetzima
DrugFluoxetine
Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
Also known as: Prozac

What researchers measure

Primary outcomes

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.
Time frame: Baseline (Week 0) to Week 8

Secondary outcomes

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.
Time frame: Baseline (Week 0) to Week 8

Results

Posted Sep 7, 2020

Participant flow

Double-blind Treatment Period

Participant flow — Double-blind Treatment Period
Milestone	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
Started	142	136	139	135
Safety population	141	134	138	134
Completed	117	115	107	109
Not completed	25	21	32	26
Withdrew: Did not receive treatment	1	2	1	1
Withdrew: Adverse event	4	7	11	7
Withdrew: Lack of efficacy	2	0	2	2
Withdrew: Withdrawal of consent	10	7	5	5
Withdrew: Lost to follow-up	7	4	5	8
Withdrew: Investigational product non-compliance	1	0	3	1
Withdrew: Reason not specified	0	1	5	2

Double-blind Down-taper Period

Participant flow — Double-blind Down-taper Period
Milestone	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
Started	111	109	104	107
Completed	111	109	104	107
Not completed	0	0	0	0

Outcome measures

PrimaryChange From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score

CDRS-R is a 17-item scale measuring presence and severity of symptoms commonly associated with childhood depression and is scored on a 1-to-5- or 1-to-7-point scale. Rating of 1 indicates normal function. The CDRS-R total score ranges from 17 to 113; higher score indicates more severe depression. A negative change from Baseline indicates improvement. Mixed Model for Repeated Measures (MMRM) was used for analysis.

Time frame:: Baseline (Week 0) to Week 8
Reported as:: Least squares mean · score on a scale

Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score
score on a scale	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
Change From Baseline in Children's Depression Rating Scale-Revised (CDRS-R) Total Score	-22.90 ± 1.09	-23.28 ± 1.11	-22.64 ± 1.12	-24.37 ± 1.12

Statistical analysis

Placebo vs Levomilnacipran 40 mg/Day · Mixed Model Repeated Measures (MMRM) · p = 0.8035 · Least squares (ls) mean difference: -0.38 · 95% CI -3.41 to 2.64Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Placebo vs Levomilnacipran 80 mg/Day · MMRM · p = 0.8681 · Ls mean difference: 0.26 · 95% CI -2.80 to 3.31Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Placebo vs Fluoxetine 20 mg/Day · MMRM · p = 0.3439 · Ls mean: -1.47 · 95% CI -4.52 to 1.58Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.

SecondaryChange From Baseline in Clinical Global Impression-Severity (CGI-S) Scale

The CGI-S is a clinician-rated scale used to rate the severity of the participants current state of mental illness compared with MDD population. The participant was rated on a scale from 1 to 7, where 1= Very much improved; 2= Much improved; 3= Minimally improved; 4= No change; 5= Minimally worse; 6= Much worse; 7= Very much worse. Higher score indicates worsening of mental illness. A negative change from Baseline indicates improvement. MMRM was used for analysis.

Time frame:: Baseline (Week 0) to Week 8
Reported as:: Least squares mean · score on a scale

Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale
score on a scale	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale	-1.54 ± 0.10	-1.52 ± 0.10	-1.52 ± 0.10	-1.68 ± 0.10

Statistical analysis

Placebo vs Levomilnacipran 40 mg/Day · MMRM · p = 0.8788 · Ls mean difference: 0.02 · 95% CI -0.25 to 0.29Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Placebo vs Levomilnacipran 80 mg/Day · MMRM · p = 0.9230 · Ls mean difference: 0.01 · 95% CI -0.26 to 0.29Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.
Placebo vs Fluoxetine 20 mg/Day · MMRM · p = 0.2895 · Ls mean difference: -0.15 · 95% CI -0.42 to 0.13Estimates and p-values are based on MMRM with treatment group, pooled study center, visit, and treatment group-by-visit interaction as fixed effects, and baseline and baseline-by-visit as covariates using an unstructured covariance matrix.

Adverse events

Collected over First dose of study treatment to end of study follow-up (Up to 10 Weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/141 (0%)	0/141 (0%)	33/141 (23.4%)
Levomilnacipran 40 mg/Day	0/134 (0%)	2/134 (1.5%)	54/134 (40.3%)
Levomilnacipran 80 mg/Day	0/138 (0%)	0/138 (0%)	63/138 (45.7%)
Fluoxetine 20 mg/Day	0/134 (0%)	4/134 (3%)	41/134 (30.6%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
OverdoseInjury, poisoning and procedural complications	0/141	1/134	0/138	0/134
Intentional overdoseInjury, poisoning and procedural complications	0/141	0/134	0/138	1/134
Suicide attemptPsychiatric disorders	0/141	1/134	0/138	1/134
Suicidal ideationPsychiatric disorders	0/141	0/134	0/138	1/134
FaecalomaGastrointestinal disorders	0/141	0/134	0/138	1/134

Most frequent other events

Most frequent other events
Event	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day
NauseaGastrointestinal disorders	8/141	19/134	22/138	5/134
HeadacheNervous system disorders	15/141	20/134	19/138	13/134
TachycardiaCardiac disorders	1/141	13/134	12/138	5/134
VomitingGastrointestinal disorders	3/141	11/134	11/138	4/134
Decreased appetiteMetabolism and nutrition disorders	2/141	7/134	9/138	10/134
DizzinessNervous system disorders	5/141	5/134	9/138	3/134
SomnolenceNervous system disorders	3/141	6/134	8/138	2/134
NasopharyngitisInfections and infestations	3/141	4/134	7/138	7/134
Abdominal pain upperGastrointestinal disorders	4/141	6/134	7/138	4/134

Baseline characteristics

Safety Population included all participants in the Randomized Population who took at least 1 dose of double-blind investigational product.

Age, Continuous
Age, Continuous(years)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
Mean	14.3 ± 1.59	14.8 ± 1.62	14.8 ± 1.75	14.7 ± 1.67	14.7 ± 1.67

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
Female	98	94	87	84	363
Male	43	40	51	50	184

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
Hispanic or Latino	33	36	32	36	137
Not Hispanic or Latino	108	98	106	98	410
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
American Indian or Alaska Native	1	0	1	1	3
Asian	1	1	1	1	4
Native Hawaiian or Other Pacific Islander	0	1	0	0	1
Black or African American	52	46	49	40	187
White	81	81	83	88	333
More than one race	6	4	3	4	17
Unknown or Not Reported	0	1	1	0	2

Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Children's Depression Rating Scale-Revised (CDRS-R) Total Score(score on a scale)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
Mean	61.1 (40 to 83)	61.8 (32 to 88)	59.4 (41 to 81)	61.5 (40 to 92)	60.95 (32 to 92)

Clinical Global Impression-Severity (CGI-S) Scale
Clinical Global Impression-Severity (CGI-S) Scale(score on a scale)	Placebo	Levomilnacipran 40 mg/Day	Levomilnacipran 80 mg/Day	Fluoxetine 20 mg/Day	Total
Mean	4.7 (4 to 6)	4.8 (3 to 6)	4.7 (4 to 6)	4.7 (4 to 6)	4.7 (3 to 6)

Study locations

49 sites

Harmonex, Inc
Dothan, Alabama 36303, United States
University of Arizona Department of Psychiatry
Tucson, Arizona 85724, United States
Advanced Research Center, Inc.
Anaheim, California 92801, United States
ProScience Research Group
Culver City, California 90230, United States
Sun Valley Research Center
Imperial, California 92251, United States
Alliance for Research
Long Beach, California 90807, United States
Asclepes Research Centers
Panorama City, California 91402, United States
Syrentis Clinical Research
Santa Ana, California 97025, United States
Pacific Clinical Research Medical Group
Upland, California 91786, United States
MCB Clinical Research Center
Colorado Springs, Colorado 80910, United States
Florida Clinical Research Center; LLC
Bradenton, Florida 34201, United States
Coastal Clinical Research Specialists
Fernandina Beach, Florida 32034, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida 33912, United States
Research in Miami Inc
Hialeah, Florida 33013, United States
Advanced Research Institute of Miami
Homestead, Florida 33030, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256, United States
Innovative Clinical Research, Inc.
Lauderhill, Florida 33319, United States
Medical Research Group of Central Florida
Orange City, Florida 32763, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801, United States
University of South Florida Board of Trustee
Tampa, Florida 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia 30331, United States
Institute for Behavioral Medicine
Smyrna, Georgia 30080-2620, United States
Clinical Research Institute
Stockbridge, Georgia 30281, United States
Sandeep Gaonkar, MD
Naperville, Illinois 60563, United States
NeuroMedical Institute
Panama City, Illinois 32405, United States
Kentucky Pediatric Research
Bardstown, Kentucky 40004, United States
Adams Clinical Trials, LLC
Watertown, Massachusetts 02472, United States
Alivation Research
Lincoln, Nebraska 68526, United States
Kolade Research Institute
Las Vegas, Nevada 89102, United States
Healthy Perspectives - Innovative Mental Health Services. PLLC
Nashua, New Hampshire 03060, United States
Princeton Medical Institute
Princeton, New Jersey 08540, United States
Manhattan Behavioral Medicine
New York, New York 10036, United States
Midwest Clinical Research Center
Dayton, Ohio 45417, United States
Professional Psychiatric Services
Mason, Ohio 45040, United States
IPS Research Company
Oklahoma City, Oklahoma 73106, United States
Sooner Clinical Research
Oklahoma City, Oklahoma 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma 73116, United States
Paradigm Research Professionals
Oklahoma City, Oklahoma 73118, United States
Tulsa Clinical Research, LLC
Tulsa, Oklahoma 74104, United States
Oregon Center for Clinical Investigations, Inc.
Salem, Oregon 97301, United States
UTHSC-Houston
Houston, Texas 77054, United States
Bay Area Clinical Services dba Earle Research
Houston, Texas 77058, United States
Red Oak Psychiatry Associates
Houston, Texas 77090, United States
Family Psychiatry of The Woodlands
The Woodlands, Texas 77381, United States
UVA Child and Family Psychiatry Clinic
Charlottesville, Virginia 22903, United States
Carilion Medical Center
Roanoke, Virginia 24014, United States
Northwest Clinical Research Center
Bellevue, Washington 98007, United States
Eastside Therapeutic Resource dba Core Clinical
Everett, Washington 98201, United States
INSPIRA Clinical Research
San Juan, 00918, Puerto Rico

References and documents

Study documents

Statistical analysis plan ↗ · Oct 3, 2019
Study protocol ↗ · Mar 25, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Aug 2019, 49 months.

Results were first posted in Sep 2020, 1 year after primary completion.

Of 95 industry-sponsored phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 33. This study's 49 months is above that.

Counting every sponsor, half of 124 studies reached it within 27 months; a quarter within 21 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 28, 2015
First posted: May 1, 2015
StartActual: Jun 23, 2015
Primary completionActual: Aug 19, 2019
CompletionActual: Aug 19, 2019
Results first posted: Sep 7, 2020
Last update: Sep 7, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02431806
Lead sponsor: Forest Laboratories
Responsible party: Sponsor
First posted: May 1, 2015
Start date: Jun 23, 2015
Primary completion: Aug 19, 2019
Completion: Aug 19, 2019
Results posted: Sep 7, 2020
Last update: Sep 7, 2020

Study contacts

Daniel Radecki

study director · Forest Research Institute, Inc., an affiliate of Allergan, plc

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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