Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02446132
Collaborator
(none)
1,200
241
3
94
5
0.1
Study Details
Study Description
Brief Summary
This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.
Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).
Approximately 1200 participants will be enrolled at approximately 250 centers globally.
All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
1200 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Study Start Date
:
Dec 1, 2015
Anticipated Primary Completion Date
:
Oct 1, 2023
Anticipated Study Completion Date
:
Oct 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AVP-786 (dose 1) AVP-786 dose 1; capsules administered twice a day over a 52-week period |
Drug: AVP-786
|
| Experimental: AVP-786 (dose 2) AVP-786 dose 2; capsules administered twice a day over a 52-week period |
Drug: AVP-786
|
| Experimental: AVP-786 (dose 3) AVP-786 dose 3; capsules administered twice a day over a 52-week period |
Drug: AVP-786
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with any Treatment-Emergent Adverse Event [up to 64 weeks]
- Number of Participants with any Treatment-Emergent Serious Adverse Event [up to 64 weeks]
- Number of Participants with any abnormal, clinically significant Clinical Laboratory Value [up to 52 weeks]
- Number of Participants with any abnormal, clinically significant 12-lead Electrocardiogram (ECG) value [up to 52 weeks]
- Number of Participants with any abnormal, clinically significant Physical and Neurological Examination finding [up to 52 weeks]
- Number of participants with any abnormal, clinically significant vital sign value [up to 52 weeks]
- Change from Baseline to Week 64 in the Sheehan Suicidality Tracking Scale (S-STS) Score [Baseline; Week 64]
- Change from Baseline to Week 52 in the Mini-Mental State Examination (MMSE) Score [Baseline; Week 52]
- Change from Baseline to Week 52 in the Epworth Sleepiness Scale (ESS) Score [Baseline; Week 52]
Secondary Outcome Measures
- Change from Baseline to Week 64 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [Baseline; Week 64]
- Change from Baseline to Week 52 in the Agitation/Aggression, Irritability/Lability, and Aberrant Motor Behavior Domain Scores of the Neuropsychiatric Inventory (NPI) [Baseline; Week 52]
- Change from Baseline to Week 64 in the modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change-Agitation (mADCS-CGIC-Agitation) Score [Baseline; Week 64]
- Change from Baseline to Week 52 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [Baseline; Week 52]
- Change from Baseline to Week 52 in the Patient Global Impression of Change (PGIC) Score [Baseline; Week 52]
PGIC (rated by caregiver)
- Change from Baseline to Week 52 in the Dementia Quality of Life (DEMQOL) Score [Baseline; Week 52]
- Change from Baseline to Week 52 in the Resource Utilization in Dementia (RUD) Score [Baseline; Week 52]
- Change from Baseline to Week 52 in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) for Participants from Study 17-AVP-786-305 [Baseline; Week 52]
Other Outcome Measures
- Number of participants using concomitant medications [up to 64 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
-
Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
-
Either out-patients or residents of an assisted-living facility or a skilled nursing home
-
Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
-
Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
-
Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
-
Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
Exclusion Criteria:
-
Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
-
Participants determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
-
Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brain and Spine Center | Chandler | Arizona | United States | 85226 |
| 2 | Banner Alzheimer's Institute | Phoenix | Arizona | United States | 85006 |
| 3 | NoesisPharma, LLC | Phoenix | Arizona | United States | 85032 |
| 4 | Perseverance Research Center, LLC | Scottsdale | Arizona | United States | 85254 |
| 5 | Health Initiatives Research | Fayetteville | Arkansas | United States | 72703 |
| 6 | Behavioral Research Specialists, LLC | Glendale | California | United States | 91206 |
| 7 | Irvine Center for Clinical Research | Irvine | California | United States | 92614 |
| 8 | University of California, Irvine | Irvine | California | United States | 92697 |
| 9 | Omega Clinical Trials, LLC | La Habra | California | United States | 90631 |
| 10 | Collaborative Neuroscience Network, LLC. | Long Beach | California | United States | 90806 |
| 11 | Alliance for Wellness, Inc dba Alliance for Research | Long Beach | California | United States | 90807 |
| 12 | Shankle Clinic | Newport Beach | California | United States | 92663 |
| 13 | NRC Research Institute | Orange | California | United States | 92868 |
| 14 | California Neurological Services | Panorama City | California | United States | 91402 |
| 15 | Havana Research Institute Site 787 | Pasadena | California | United States | 91105 |
| 16 | Havana Research Institute | Pasadena | California | United States | 91105 |
| 17 | Pacific Research Network, Inc. #1 | San Diego | California | United States | 92103 |
| 18 | Pacific Research Network, Inc. #2 | San Diego | California | United States | 92103 |
| 19 | VA San Diego Healthcare System | San Diego | California | United States | 92103 |
| 20 | HB Clinical Trials Inc. | Santa Ana | California | United States | 92704 |
| 21 | Syrentis Clinical Research | Santa Ana | California | United States | 92705 |
| 22 | Viking Clinical Research | Temecula | California | United States | 92591 |
| 23 | New Foundation Medical Group Clinical Trials | Tustin | California | United States | 92780 |
| 24 | Lytle and Weiss, PLLC dba Clinical Trials of the Rockies | Denver | Colorado | United States | 80209 |
| 25 | Connecticut Clinical Research | Cromwell | Connecticut | United States | 06416 |
| 26 | Associated Neurologists, PC | Danbury | Connecticut | United States | 06810 |
| 27 | Geriatric and Adult Psychiatry LLC | Hamden | Connecticut | United States | 06518 |
| 28 | Coastal Connecticut Research, LLC | New London | Connecticut | United States | 06320 |
| 29 | Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | United States | 06851 |
| 30 | JEM Research Institute | Atlantis | Florida | United States | 33462 |
| 31 | Neurology Offices of South Florida | Boca Raton | Florida | United States | 33428 |
| 32 | Clinical Research Of Brandon, LLC | Brandon | Florida | United States | 33511 |
| 33 | Meridien Research | Brooksville | Florida | United States | 34601 |
| 34 | Quantum Laboratories, Inc. | Deerfield Beach | Florida | United States | 33064 |
| 35 | Moonshine Research Center, Inc | Doral | Florida | United States | 33166 |
| 36 | Science Connections, LLC | Doral | Florida | United States | 33166 |
| 37 | University of Florida | Gainesville | Florida | United States | 32607 |
| 38 | Finlay Medical Research Corp | Greenacres City | Florida | United States | 33467 |
| 39 | Direct Helpers Research Center | Hialeah | Florida | United States | 33012 |
| 40 | Indago Research & Health Center, Inc. | Hialeah | Florida | United States | 33012 |
| 41 | New Life Medical Research Center, Inc. | Hialeah | Florida | United States | 33012 |
| 42 | Reliable Clinical Research,LLC | Hialeah | Florida | United States | 33012 |
| 43 | Research in Miami, Inc | Hialeah | Florida | United States | 33013 |
| 44 | The Research Center, Inc | Hialeah | Florida | United States | 33013 |
| 45 | Berma Research Group | Hialeah | Florida | United States | 33016 |
| 46 | Galiz Research | Hialeah | Florida | United States | 33016 |
| 47 | Maxblue Institute | Hialeah | Florida | United States | 33018 |
| 48 | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | United States | 32256 |
| 49 | SIH Research, LLC | Kissimmee | Florida | United States | 34741 |
| 50 | Alzheimer's Research and Treatment Center #1 | Lake Worth | Florida | United States | 33449 |
| 51 | Alzheimer's Research and Treatment Center #2 | Lake Worth | Florida | United States | 33449 |
| 52 | Alzheimer's Research and Treatment Center #3 | Lake Worth | Florida | United States | 33449 |
| 53 | Meridien Research | Lakeland | Florida | United States | 33803 |
| 54 | Premier Clinical Research Institute, Inc. #1 | Miami | Florida | United States | 33122 |
| 55 | Premier Clinical Research Institute, Inc. #2 | Miami | Florida | United States | 33122 |
| 56 | Global Medical Institutes, LLC | Miami | Florida | United States | 33125 |
| 57 | Optimus U Corp | Miami | Florida | United States | 33125 |
| 58 | Project 4 Research #1 | Miami | Florida | United States | 33125 |
| 59 | Project 4 Research #2 | Miami | Florida | United States | 33125 |
| 60 | BioMed Research Institute | Miami | Florida | United States | 33126 |
| 61 | Finlay Medical Research Corp | Miami | Florida | United States | 33126 |
| 62 | CCM Clinical Research Group | Miami | Florida | United States | 33133 |
| 63 | Innova Clinical Trials | Miami | Florida | United States | 33133 |
| 64 | Advance Medical Research Center #1 | Miami | Florida | United States | 33135 |
| 65 | Advance Medical Research Center #2 | Miami | Florida | United States | 33135 |
| 66 | Dade Research Center Llc | Miami | Florida | United States | 33135 |
| 67 | Vitae Researrch Center LLC | Miami | Florida | United States | 33135 |
| 68 | University of Miami | Miami | Florida | United States | 33136 |
| 69 | Miami Jewish Health Systems, Inc. | Miami | Florida | United States | 33137 |
| 70 | AMB Research Center, Inc. | Miami | Florida | United States | 33144 |
| 71 | United Health Research Corp. #1 | Miami | Florida | United States | 33144 |
| 72 | United Health Research Corp. #2 | Miami | Florida | United States | 33144 |
| 73 | Advanced Medical Center Group | Miami | Florida | United States | 33145 |
| 74 | Future Care Solution, LLC | Miami | Florida | United States | 33165 |
| 75 | Clinical Research Associates of South Florida #1 | Miami | Florida | United States | 33172 |
| 76 | Clinical Research Associates of South Florida #2 | Miami | Florida | United States | 33172 |
| 77 | Coral Research Clinic Corp | Miami | Florida | United States | 33175 |
| 78 | P&S Research, Llc. | Miami | Florida | United States | 33175 |
| 79 | Pharmax Research of South Florida | Miami | Florida | United States | 33175 |
| 80 | Miami Dade Medical Research Institute, LLC | Miami | Florida | United States | 33176 |
| 81 | The Neurology Research Group, LLC | Miami | Florida | United States | 33176 |
| 82 | International Research Associates, LLC | Miami | Florida | United States | 33183 |
| 83 | Kendall Research Institute | Miami | Florida | United States | 33183 |
| 84 | Nuovida Research Center Corp. | Miami | Florida | United States | 33186 |
| 85 | Research Institute of West Kendall | Miami | Florida | United States | 33186 |
| 86 | Collier Neurologic Specialists, LLC | Naples | Florida | United States | 34102 |
| 87 | Naples Research, Inc | Naples | Florida | United States | 34102 |
| 88 | Bayside Clinical Research | New Port Richey | Florida | United States | 34655 |
| 89 | Lazlo J. Mate, MD, PA | North Palm Beach | Florida | United States | 33408 |
| 90 | Research Centers of America, LLC | Oakland Park | Florida | United States | 33334 |
| 91 | Sensible Healthcare | Ocoee | Florida | United States | 34761 |
| 92 | Compass Research, LLC | Orlando | Florida | United States | 32806 |
| 93 | Neurology Associates of Ormond Beach | Ormond Beach | Florida | United States | 32174 |
| 94 | Innovation Medical Research Center | Palmetto Bay | Florida | United States | 03157 |
| 95 | IMIC Inc. | Palmetto Bay | Florida | United States | 33157 |
| 96 | University of West Florida | Pensacola | Florida | United States | 32514 |
| 97 | Suncoast Neuroscience Associates, Inc. | Saint Petersburg | Florida | United States | 33713 |
| 98 | Roskamp Institute | Sarasota | Florida | United States | 34243 |
| 99 | Olympian Clinical Research | Tampa | Florida | United States | 33609 |
| 100 | University of South Florida | Tampa | Florida | United States | 33613 |
| 101 | Compass Research North, LLC | The Villages | Florida | United States | 32162 |
| 102 | Neurology Research Institute Palm Beach, LLC #1 | West Palm Beach | Florida | United States | 33407 |
| 103 | Neurology Research Institute Palm Beach, LLC #2 | West Palm Beach | Florida | United States | 33407 |
| 104 | Florida Premier Research Institute | Winter Park | Florida | United States | 32789 |
| 105 | Emory Brain Health Center | Atlanta | Georgia | United States | 30329 |
| 106 | NeuroTrials Research Inc | Atlanta | Georgia | United States | 30342 |
| 107 | Columbus Research & Wellness Institute, INC | Columbus | Georgia | United States | 31904 |
| 108 | Medical Research & Health Education Foundation, Inc. | Columbus | Georgia | United States | 31909 |
| 109 | NeuroStudies. Net, LLC | Decatur | Georgia | United States | 30033 |
| 110 | Alexian Brothers Neurosciences Institute | Elk Grove Village | Illinois | United States | 60007 |
| 111 | Behavioral Health Care Associates | Schaumburg | Illinois | United States | 60194 |
| 112 | Indiana University School of Medicine | Indianapolis | Indiana | United States | 46202 |
| 113 | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana | United States | 46256 |
| 114 | MidAmerica Neuroscience Research Foundation | Lenexa | Kansas | United States | 66214 |
| 115 | Four Rivers Clinical Research Inc. | Paducah | Kentucky | United States | 42003 |
| 116 | J. Gary Booker, MD, APMC | Shreveport | Louisiana | United States | 71104 |
| 117 | The Samuel & Alexia Bratton Memory Clinic | Easton | Maryland | United States | 21601 |
| 118 | Mir Neurology | Hagerstown | Maryland | United States | 21742 |
| 119 | Bedford VA Hospital | Bedford | Massachusetts | United States | 01730 |
| 120 | Boston Center for Memory | Newton | Massachusetts | United States | 02459 |
| 121 | Alzheimer's Disease Center | Quincy | Massachusetts | United States | 02169 |
| 122 | Onyx Clinical Research, LLC | Caro | Michigan | United States | 48723 |
| 123 | Michigan State University Department of Neurology | East Lansing | Michigan | United States | 48824 |
| 124 | Bronson Neurobehavioral Health | Paw Paw | Michigan | United States | 49079 |
| 125 | Galen Research | Chesterfield | Missouri | United States | 63005 |
| 126 | Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | United States | 63141 |
| 127 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 128 | PsychCare Consultants Research | Saint Louis | Missouri | United States | 63128 |
| 129 | Clinical Research Professionals | Saint Louis | Missouri | United States | 63141 |
| 130 | Geriatric Solutions, LLC | Las Vegas | Nevada | United States | 89144 |
| 131 | Flora Baker Center for Alzheimer's Disease and Related Disorders | Marmora | New Jersey | United States | 08223 |
| 132 | The NeuroCognitive Institute | Mount Arlington | New Jersey | United States | 07856 |
| 133 | Bio Behavioral Health | Toms River | New Jersey | United States | 08755 |
| 134 | Dent Neurologic Institute | Amherst | New York | United States | 14226 |
| 135 | Brooklyn Medical Institute | Brooklyn | New York | United States | 11214 |
| 136 | Integrative Clinical Trials LLC #1 | Brooklyn | New York | United States | 11229 |
| 137 | Integrative Clinical Trials LLC #2 | Brooklyn | New York | United States | 11229 |
| 138 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 139 | Manhattan Behavioral Medicine, PLLC | New York | New York | United States | 10036 |
| 140 | Eastside Comprehensive Medical Center, LLC | New York | New York | United States | 10128 |
| 141 | Nathan S. Kline Institute for Psychiatric Research #1 | Orangeburg | New York | United States | 10962 |
| 142 | Nathan S. Kline Institute for Psychiatric Research #2 | Orangeburg | New York | United States | 10962 |
| 143 | University of Rochester Medical Center | Rochester | New York | United States | 14620 |
| 144 | Psychiatry and Alzheimer's Care of Rochester, PLLC | Rochester | New York | United States | 14623 |
| 145 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
| 146 | Burke Rehabilitation Hospital | White Plains | New York | United States | 10605 |
| 147 | Herbert Harris, Md, Phd, Pa | Chapel Hill | North Carolina | United States | 27517 |
| 148 | ANI Neurology PLLC dba Alzheimer's Memory Center | Charlotte | North Carolina | United States | 28270 |
| 149 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 150 | Daystar Clinical Research Inc | Akron | Ohio | United States | 44313 |
| 151 | Neurology and Neuroscience Associates, Inc. | Akron | Ohio | United States | 44320 |
| 152 | Insight Clinical Trials, LLC | Beachwood | Ohio | United States | 44122 |
| 153 | Insight Neuroscience, LLC | Bellevue | Ohio | United States | 44811 |
| 154 | Valley Medical Research Site #788 | Centerville | Ohio | United States | 45459 |
| 155 | Valley Medical Research | Centerville | Ohio | United States | 45459 |
| 156 | CTI Clinical Research Center | Cincinnati | Ohio | United States | 45212 |
| 157 | University of Cincinnati | Cincinnati | Ohio | United States | 45219 |
| 158 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 159 | Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital | Lakewood | Ohio | United States | 44107 |
| 160 | IPS Research Company | Oklahoma City | Oklahoma | United States | 73103 |
| 161 | Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | United States | 73112 |
| 162 | Tulsa Clinical Research, LLC | Tulsa | Oklahoma | United States | 74104 |
| 163 | Heritage Valley Medical Group, Inc. | Beaver | Pennsylvania | United States | 15009 |
| 164 | The Birches at Newton / Family Medical Associates | Levittown | Pennsylvania | United States | 19056 |
| 165 | Drexel University | Philadelphia | Pennsylvania | United States | 19107 |
| 166 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 167 | Abington Neurological Associates, LTD | Willow Grove | Pennsylvania | United States | 19090 |
| 168 | Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | United States | 02914 |
| 169 | RH Johnson VA Medical Center | Charleston | South Carolina | United States | 29401 |
| 170 | Roper St. Francis Healthcare | Charleston | South Carolina | United States | 29401 |
| 171 | Coastal Neurology, PA | Port Royal | South Carolina | United States | 29935 |
| 172 | BG Neurology | Spartanburg | South Carolina | United States | 29307 |
| 173 | Neurology Clinic, P.C. | Cordova | Tennessee | United States | 38018 |
| 174 | Clinical Research Solutions | Franklin | Tennessee | United States | 37064 |
| 175 | Texas Neurology, P.A. | Dallas | Texas | United States | 75214 |
| 176 | Neurology Consultants of Dallas, PA | Dallas | Texas | United States | 75231 |
| 177 | University Texas Southwestern Medical Center | Dallas | Texas | United States | 75390-8898 |
| 178 | InSite Clinical Research Site #576 | DeSoto | Texas | United States | 75115 |
| 179 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 180 | Houston Methodist Neurological Institute | Houston | Texas | United States | 77030 |
| 181 | University Hills Clinical Research | Irving | Texas | United States | 75062 |
| 182 | Neurology Associates of Arlington | Mansfield | Texas | United States | 76063 |
| 183 | Texas Medical Research Associates, L.L.C. | San Antonio | Texas | United States | 78238 |
| 184 | Ericksen Research and Development | Clinton | Utah | United States | 84015 |
| 185 | Pharmaceuticals Research Associates, Inc. | Salt Lake City | Utah | United States | 84107 |
| 186 | Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic | Bennington | Vermont | United States | 05201 |
| 187 | Neuropsychiatric Associates | Woodstock | Vermont | United States | 05091 |
| 188 | Sentara Neurosciences Institute | Norfolk | Virginia | United States | 23510 |
| 189 | Veteran Affairs Medical Center, Salem Virginia | Salem | Virginia | United States | 24153 |
| 190 | Northwest Clinical Research Center | Bellevue | Washington | United States | 98007 |
| 191 | Frontier Institute | Spokane | Washington | United States | 99204 |
| 192 | IPC Research | Waukesha | Wisconsin | United States | 53188 |
| 193 | Center for Mental Health - Ruse | Ruse | Bulgaria | ||
| 194 | Medical Center Sveti Naum | Sofia | Bulgaria | 1113 | |
| 195 | Vrach and Sv. Sv. Kuzma and Damian | Sofia | Bulgaria | 1408 | |
| 196 | University Multiprofile Hospital for Active Treatment Alexandrovska | Sofia | Bulgaria | ||
| 197 | Medica Plus Medical Center | Veliko Tarnovo | Bulgaria | ||
| 198 | Dr. Alexander McIntyre Inc. | Penticton | Canada | ||
| 199 | Fakultni Nemocnice u sv. Anny v Brne | Brno | Czechia | ||
| 200 | Fakultní Nemocnice Hradec Králové | Hradec Kralové | Czechia | ||
| 201 | NeuropsychiatrieHK | Hradec Kralové | Czechia | ||
| 202 | Brain-Soultherapy | Kladno | Czechia | ||
| 203 | Námestí národního odboje 692 | Kutna Hora | Czechia | ||
| 204 | A-Shine s.r.o. Site #731 | Plzen | Czechia | ||
| 205 | AD71 | Praha | Czechia | ||
| 206 | Clintrial | Praha | Czechia | ||
| 207 | Neurologicka Ambulance - Forbeli | Praha | Czechia | ||
| 208 | Neuropsychiatrie | Praha | Czechia | ||
| 209 | Vestra Clinics | Rychnov nad Kněžnou | Czechia | ||
| 210 | Centre Hospitalier Universitaire Dijon Bourgogn | Dijon Cedex | France | ||
| 211 | Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord | Saint-Etienne | France | ||
| 212 | Centre Hospitalier Universitaire Toulouse - Casselardit Ancely | Toulouse | France | ||
| 213 | Dr. Kenessey Albert Kórház-Rendelőintézet | Balassagyarmat | Hungary | ||
| 214 | Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly | Budapest | Hungary | ||
| 215 | Semmelweis Egyetem | Budapest | Hungary | ||
| 216 | Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz | Debrecen | Hungary | ||
| 217 | PsychoTech | Pécs | Hungary | ||
| 218 | Azienda Ospedaliera Sant'Andrea | Roma | Italy | ||
| 219 | Fondazione Policlinico Tor Vergata | Roma | Italy | ||
| 220 | Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico | Roma | Italy | ||
| 221 | Ksiedza Hugona Kollataja 9 | Bydgoszcz | Poland | ||
| 222 | Care Clinic | Katowice | Poland | ||
| 223 | Wielospecjalistyczna Poradnia Lekarska Synapsis | Katowice | Poland | ||
| 224 | Krakowska Akademia Neurologii | Kraków | Poland | ||
| 225 | Malopolskie Centrum Medyczne | Kraków | Poland | ||
| 226 | Medycyna Milorzab | Lodz | Poland | ||
| 227 | Solumed Centrum Medyczne | Poznań | Poland | ||
| 228 | Centrum Medyczne Euromedis | Szczecin | Poland | ||
| 229 | Centrum Medyczne NeuroProtect | Warszawa | Poland | ||
| 230 | ACF Neurological Services | Cape Town | South Africa | ||
| 231 | Cape Trial Centre | Cape Town | South Africa | ||
| 232 | Flexivest Fourteen Research Centre | Cape Town | South Africa | ||
| 233 | Apollo Clinical Research | Johannesburg | South Africa | ||
| 234 | Medical and Dental Centre | Rosebank | South Africa | ||
| 235 | Fundació ACE | Barcelona | Spain | ||
| 236 | Hospital Clinic de Barcelona | Barcelona | Spain | ||
| 237 | Hospital General Universitario de Elche | Elche | Spain | ||
| 238 | Hospital Universitario de Salamanca | Salamanca | Spain | ||
| 239 | Hospital Universitario Virgen Macarena | Sevilla | Spain | ||
| 240 | Complejo Asistencial de Zamora Hospital Virgen de la Concha | Zamora | Spain | ||
| 241 | Hospital Viamed Montecanal | Zaragoza | Spain |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT02446132
Other Study ID Numbers:
- 15-AVP-786-303
- 2017-002455-29
First Posted:
May 18, 2015
Last Update Posted:
Aug 24, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: