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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000064-28 | EudraCT Number |
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Business decision to stop the program.
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The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225 mg of Rapastinel compared to placebo in the prevention of relapse in participants with major depressive disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel weekly | Experimental | Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) |
|
| Rapastinel clinically driven schedule | Experimental | Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) |
|
| Placebo weekly | Placebo Comparator | Placebo (prefilled syringe, weekly IV administration) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel | Drug | Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) | The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse. | 52 Weeks |
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Inclusion Criteria: -
Exclusion Criteria: -
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alea Research | Phoenix | Arizona | 85012 | United States | ||
| Woodland International Research Group |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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363 patients enrolled in the Open Label Treatment Period (OLTP). Of these, 209 completed OLTP and 137 entered Double Blind Treatment Period (DBTP) and were randomized. Patients who completed or discontinued from the study can enter a 2-wk safety follow-up period (SFUP). 165 patients from OLTP and 91 patients from DBTP entered the SFUP.
Patients from RAP-MD-33 completed one of the rapastinel lead-in studies - RAP-MD-30, RAP-MD-31, or RAP-MD-32.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label Treatment Period (OLTP) Weekly Rapastinel | Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP. |
| FG001 | DBTP Placebo Weekly | Placebo (prefilled syringe, weekly IV administration) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-Label Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2018 | Jul 10, 2020 |
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| Placebo | Drug | Placebo (prefilled syringe, weekly IV administration) |
|
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| California Pharmaceutical Research Institute | Anaheim | California | 92804 | United States |
| Synergy Research San Diego | National City | California | 91950 | United States |
| Excell Research Inc. | Oceanside | California | 92056 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group,Inc. | Sherman Oaks | California | 91403 | United States |
| Viking Clinical Research Ltd. | Temecula | California | 92591 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Clinical NeuroscienceSolutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Innova Clinical Trials | Miami | Florida | 33133 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Institute for Advanced Medical Research | Atlanta | Georgia | 30341 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Iris Research, Inc. | Smyrna | Georgia | 30082 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10028 | United States |
| Eastside Comprehensive Medical Center | New York | New York | 10128 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| New Hope Clinical Research | Charlotte | North Carolina | 28211 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | United States |
| Donald J. Garcia, Jr., MD, PA | Austin | Texas | 78737 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Bugát Pál Hospital, Clinexpert | Gyöngyös | 3200 | Hungary |
| Medical corporation Sato-Kai Yuge Hospital | Kumamoto | 861-8002 | Japan |
| Sagaarashiyama-Tanaka Clinic | Kyoto | 616-8421 | Japan |
| Sangenjaya Neurology- Psychosomatic Clinic | Setagaya-ku | 154-0004 | Japan |
| Yoyogi Mental Clinic | Shibuya-ku | 151-0051 | Japan |
| Maynds Tower Mental Clinic | Shibuya-ku | 151-0053 | Japan |
| Ohwa Mental Clinic | Toshima-ku | 170-0002 | Japan |
| Centrum Medyczne Luxmed Sp.z o.o. | Lublin | 20-109 | Poland |
| VAVRUŠOVÁ CONSULTING s.r.o., Psychiatrická ambulancia | Bratislava | 851 01 | Slovakia |
| MENTUM, s.r.o. | Bratislava Mestská Časť Ružinov | 820 07 | Slovakia |
| Liptovská nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovský Mikuláš | Liptovský Mikuláš | 031 23 | Slovakia |
| PsychoLine s.r.o., Psychiatrická ambulancia | Rimavská Sobota | 979 01 | Slovakia |
| FG002 | DBTP Rapastinel Clinically Driven Schedule | Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) |
| FG003 | DBTP Rapastinel Weekly | Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Double-Blind Treatment Period (DBTP) |
|
|
| Safety Follow-Up Period |
|
|
The Double-blind Safety Population consisted of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of double-blind IP.
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| ID | Title | Description |
|---|---|---|
| BG000 | DBTP Placebo Weekly | Placebo (prefilled syringe, weekly IV administration) |
| BG001 | DBTP Rapastinel Clinically Driven Schedule | Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) |
| BG002 | DBTP Rapastinel Weekly | Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Time to First Relapse During the 52 Weeks of the Double-Blind Treatment Period (DBTP) | The time in days to first relapse is defined as the number of days from the date of randomization to the first relapse. | The Double-blind Safety Population consisted of all patients in the Open-label Safety Population who were randomized to a treatment group during the DBTP of the study and received at least 1 dose of double-blind IP. | Posted | Median | 95% Confidence Interval | Days | 52 Weeks |
|
|
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The study consisted of an 8 to 16 week OLTP; followed by a randomized DBTP of up to 52 weeks; followed by a 2 week safety period.
Adverse event data for non-randomized participants in the OLTP also include AEs that occurred during the safety follow period.
Adverse event data for randomized participants in the DBTP were collected for up to 54 weeks which included the 2 week safety follow up period.
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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 | Open-Label Treatment Period | Rapastinel 225 milligrams (mg) or 450 mg intravenous (IV) once a week during OLTP. | 0 | 363 | 4 | 363 | 44 | 363 |
| EG001 | DBTP Placebo Weekly | Placebo (prefilled syringe, weekly IV administration) | 0 | 40 | 1 | 40 | 17 | 40 |
| EG002 | DBTP Rapastinel Clinically Driven Schedule | Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks) | 0 | 42 | 1 | 42 | 9 | 42 |
| EG003 | DBTP Rapastinel Weekly | Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) | 0 | 55 | 0 | 55 | 13 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial seizures | Nervous system disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA Version 21.2 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.2 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 21.2 | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 21.2 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 21.2 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 21.2 | Systematic Assessment |
|
Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 26, 2019 | Jul 10, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Protocol Violation |
|
| Study terminated by sponsor |
|
| Miscellaneous Reasons |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|