Clinical Trials - ALKS

NCT IDTitleStatusPhasesStart DateCompletion DatePrimary Completion Date
NCT06843590A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic HypersomniaRECRUITINGPHASE22025-05-222026-062026-06
NCT06767683A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic HypersomniaRECRUITINGPHASE2, PHASE32025-01-272028-062028-06
NCT06555783A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2ACTIVE_NOT_RECRUITINGPHASE22024-07-262025-112025-11
NCT06358950A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)COMPLETEDPHASE22024-03-282025-07-312025-06-19
NCT05547100Study of the Breast Milk Pharmacokinetics of Olanzapine and SamidorphanCOMPLETEDPHASE12022-09-142022-11-192022-11-19
NCT05303064Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderRECRUITINGPHASE32022-06-302026-092026-09
NCT04987229Long-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsENROLLING_BY_INVITATIONPHASE32021-10-222027-092027-09
NCT05019105Phase 1 ALKS 1140 in Healthy AdultsTERMINATEDPHASE12021-10-132022-08-232022-08-23
NCT04987658Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I DisorderCOMPLETEDPHASE12021-07-222023-08-112023-08-11
NCT03963973A 28 Day Parallel Group Study to Assess the Effects of RDN-929TERMINATEDPHASE12019-05-162020-01-222020-01-22
NCT03668314Single and Multiple Ascending Dose and Food Effect PK Study in Healthy Adult and Elderly SubjectsCOMPLETEDPHASE12018-10-102019-04-152019-04-15
NCT03610048A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)TERMINATEDPHASE32018-08-092020-05-012020-05-01
NCT03577262A Non-therapeutic Feasibility Study of the Radioligand [11C]-UCB-J for Imaging Synaptic DensityCOMPLETEDEARLY_PHASE12018-07-232019-08-022019-08-02
NCT03345979A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of SchizophreniaCOMPLETEDPHASE32017-11-152019-03-122019-03-12
NCT03201757Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831COMPLETEDPHASE32017-06-152023-09-062023-09-06
NCT03188185A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)COMPLETEDPHASE32017-06-122020-03-052020-02-26
NCT03187769Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I DisorderCOMPLETEDPHASE32017-06-082022-01-032021-12-01
NCT02922426An Insulin Sensitivity Study in Healthy SubjectsCOMPLETEDPHASE12016-092017-07-202017-07-20
NCT02873208A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaCOMPLETEDPHASE32016-08-072019-10-172019-10-17
NCT02804568A Phase 1 Safety Study in Adults With SchizophreniaCOMPLETEDPHASE12016-062016-082016-08
NCT02696434Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROLCOMPLETEDPHASE32016-042017-11-302017-11
NCT02694328A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)COMPLETEDPHASE32016-03-022018-11-072018-11-07
NCT02669758A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With SchizophreniaCOMPLETEDPHASE32016-01-202018-06-292018-06-29
NCT02634320A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With SchizophreniaCOMPLETEDPHASE42015-122017-07-112017-07-11
NCT02634346A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)COMPLETEDPHASE32015-122017-06-072017-05-25
NCT02636842A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective DisorderCOMPLETEDPHASE12015-122016-062016-06
NCT02537574Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROLĀ® (Naltrexone for Extended-Release Injectable Suspension)COMPLETEDPHASE32015-082017-01-092016-10-27
NCT02508506Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal FunctionCOMPLETEDPHASE12015-072015-122015-12
NCT02545439A Drug-drug Interaction Study of ALKS 5461 in Healthy VolunteersCOMPLETEDPHASE12015-072015-102015-10
NCT02521857A Water Consumption Study of ALKS 5461 in Healthy VolunteersCOMPLETEDPHASE12015-072015-092015-09
NCT02479308A Study to Evaluate the Effect of ALKS 5461 on QT Intervals in Healthy VolunteersCOMPLETEDPHASE12015-062015-102015-10
NCT02504463A Study of [14c]-Samidorphan (Also Known as ALKS 33) in Healthy, Male VolunteersCOMPLETEDPHASE12015-062015-092015-09
NCT02452801Pharmacokinetics and Safety of ALKS 5461 in Healthy Subjects and Subjects With Hepatic Impairment and Normal Hepatic FunctionCOMPLETEDPHASE12015-052015-122015-12
NCT02413281A Study of the Abuse Liability Potential of ALKS 5461 in Healthy, Non-Dependent, Recreational Opioid UsersCOMPLETEDPHASE12015-032015-092015-09
NCT02320032An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable SchizophreniaCOMPLETEDPHASE12014-122016-042016-04
NCT02272764A Drug-Drug Interaction Study of ALKS 5461 in Healthy VolunteersCOMPLETEDPHASE12014-102014-112014-11
NCT02218021A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid UsersCOMPLETEDPHASE12014-082014-112014-11
NCT02218008A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 StudyCOMPLETEDPHASE32014-072016-102016-09
NCT02161718A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use DisorderCOMPLETEDPHASE22014-052017-02-012017-01-11
NCT02158533A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 StudyCOMPLETEDPHASE32014-052015-122015-12
NCT02158546A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 StudyCOMPLETEDPHASE32014-052015-122015-12
NCT02141399A Long-Term Safety Study of ALKS 5461COMPLETEDPHASE32014-052017-11-202017-11-20
NCT02085135A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)COMPLETEDPHASE32014-022014-092014-09
NCT02068105A Study of ALKS 5461 in Healthy VolunteersCOMPLETEDPHASE12014-012014-032014-03
NCT01895452An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)COMPLETEDPHASE32013-072016-062016-06
NCT01903837A Study of ALKS 3831 in Adults With SchizophreniaCOMPLETEDPHASE22013-062015-032014-12
NCT01626456A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)COMPLETEDPHASE32012-062015-042015-04
NCT01500200A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)COMPLETEDPHASE22011-122013-032013-03
NCT01469039A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With SchizophreniaCOMPLETEDPHASE32011-122014-032014-01
NCT01493726A Study of ALKS 9072 in Subjects With Chronic Stable SchizophreniaCOMPLETEDPHASE12011-122013-062013-06
NCT01436032Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic SurgeryTERMINATEDPHASE32011-102012-032012-03
NCT01418092ALK37-007: Evaluation of Safety and Efficacy of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)COMPLETEDPHASE22011-092012-062012-06
NCT01382797ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)COMPLETEDPHASE22011-082012-042012-04
NCT01366001ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With CocaineCOMPLETEDPHASE12011-082012-022012-02
NCT01381107ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDDCOMPLETEDPHASE1, PHASE22011-052011-072011-07
NCT01453374A Study of VIVITROL in the Prevention of Re-arrest and Re-incarcerationCOMPLETEDPHASE42011-012014-052014-05
NCT01098435ALK33-101: A Study of RDC-0313 (ALKS 33) in Adults With Binge Eating DisorderCOMPLETEDPHASE22010-052011-062011-05
NCT01100151ALK37-003: A Study of RDC-1036 (ALKS 37) in Adults With Opioid-induced Constipation (OIC)COMPLETEDPHASE22010-042010-122010-12
NCT01084161Study to Evaluate the Efficacy, Safety and Tolerability of N1539COMPLETEDPHASE22010-032011-012011-01
NCT00981617ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol DependenceCOMPLETEDPHASE22009-102010-082010-08
NCT00945763Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction SurgeryCOMPLETEDPHASE22009-072009-112009-11
NCT00834080ALK21-021: A Safety Study of MedisorbĀ® Naltrexone (VIVITROLĀ®) Administered to Health Care ProfessionalsCOMPLETEDPHASE32009-032012-052012-05
NCT00801684ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPDCOMPLETEDPHASE22009-022009-072009-04
NCT00800319ALK33-001: A Study of RDC-0313 Administered to Healthy AdultsCOMPLETEDPHASE12008-122009-062009-02
NCT00802035ALK29-002: A Study of Baclofen Formulations in Healthy AdultsCOMPLETEDPHASE12008-112009-022008-12
NCT00678418ALK21-013: Efficacy and Safety of MedisorbĀ® Naltrexone (VIVITROLĀ®) in Adults With Opioid DependenceCOMPLETEDPHASE32008-062010-112009-10
NCT00511836ALK21-018: Effects of MedisorbĀ® Naltrexone (VIVITROLĀ®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent AdultsCOMPLETEDPHASE42007-072009-102009-06
NCT00501631ALK21-014: Efficacy and Safety of MedisorbĀ® Naltrexone (VIVITROLĀ®) After Enforced AbstinenceCOMPLETEDPHASE32007-072011-032011-01
NCT00156936ALK21-006EXT: Long-term Safety of MedisorbĀ® Naltrexone (VIVITROLĀ®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])TERMINATEDPHASE32004-082007-012007-01
NCT00156923ALK21-010: Long-term Safety of MedisorbĀ® Naltrexone (VIVITROLĀ®) in Alcohol-dependent AdultsCOMPLETEDPHASE32003-102007-012007-01
NCT01218997ALK21-006: Long-Term Study of MedisorbĀ® Naltrexone (VIVITROLĀ®)COMPLETEDPHASE32003-082005-032005-03
NCT01218971ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of MedisorbĀ® Naltrexone (VIVITROLĀ®)COMPLETEDPHASE32002-082004-092004-09
NCT01218984ALK21-004: Single-dose Opiate Challenge of MedisorbĀ® Naltrexone (VIVITROLĀ®) in Adults Who Use OpioidsCOMPLETEDPHASE22002-032003-052003-05
NCT01218958ALK21-003: Study of MedisorbĀ® Naltrexone (VIVITROLĀ®) in Alcohol-Dependent AdultsCOMPLETEDPHASE32002-022003-092003-09
NCT00002316The Safety and Effectiveness of RMP-7 Plus Amphotericin B in Patients With HIV and Cryptococcal MeningitisCOMPLETEDPHASE1