Sleep Initiation and Maintenance Disorders News - LARVOL Sigma

Sleep Initiation and Maintenance Disorders

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14 Mechanisms of Action

|||||||||| New P2/3 trial: Treatment for Insomnia During Pregnancy (clinicaltrials.gov) - May 1, 2013
P2/3, N=0, Recruiting, Sponsor: Stanford University

||||||||||  eszopiclone / Generic mfg.
Enrollment change:  MVP#1: Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study (clinicaltrials.gov) -  Feb 19, 2013
P2/3, N=30, Completed,  Sponsor: University of Minnesota - Clinical and Translational Science Institute
N=40 --> 30

|||||||||| New P1 trial: A Study of LY2624803 in Japanese Participants With Transient Insomnia (clinicaltrials.gov) - Feb 4, 2013
P1, N=24, Completed, Sponsor: Eli Lilly and Company

|||||||||| New P1 trial: A Study of LY2624803 in Participants With Transient Insomnia (clinicaltrials.gov) - Jan 28, 2013
P1, N=32, Completed, Sponsor: Eli Lilly and Company

||||||||||  eszopiclone / Generic mfg.
Enrollment change:  A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126) (clinicaltrials.gov) -  Dec 27, 2012
P2/3, N=192, Completed,  Sponsor: Eisai Co., Ltd.
N=40 --> 30 N=70 --> 192

||||||||||  prazosin / Generic mfg.
Trial termination:  Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder (clinicaltrials.gov) -  Nov 25, 2012
P=N/A, N=20, Terminated,  Sponsor: Seattle Institute for Biomedical and Clinical Research
N=70 --> 192 Completed --> Terminated; Insufficient Enrollment

||||||||||  prazosin / Generic mfg.
Enrollment change:  Prazosin for Treating Noncombat Trauma Post-Traumatic Stress Disorder (clinicaltrials.gov) -  Nov 25, 2012
P=N/A, N=20, Terminated,  Sponsor: Seattle Institute for Biomedical and Clinical Research
Completed --> Terminated; Insufficient Enrollment N=95 --> 20

|||||||||| Enrollment change: Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia (clinicaltrials.gov) - Nov 8, 2012
P2, N=112, Completed, Sponsor: Actelion
N=95 --> 20 N=80 --> 112

|||||||||| Enrollment closed: Cognitive Behavioral Insomnia Therapy for Individuals With Fibromyalgia (clinicaltrials.gov) - Oct 25, 2012
P2/3, N=111, Active, not recruiting, Sponsor: Duke University
N=80 --> 112 Recruiting --> Active, not recruiting

|||||||||| Trial initiation date: Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms (clinicaltrials.gov) - Jul 8, 2012
P=N/A, N=90, Completed, Sponsor: University of California, Los Angeles
Recruiting --> Active, not recruiting Initiation date: Jan 2007 --> Mar 2008

|||||||||| Trial completion: Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms (clinicaltrials.gov) - Jul 8, 2012
P=N/A, N=90, Completed, Sponsor: University of California, Los Angeles
Initiation date: Jan 2007 --> Mar 2008 Active, not recruiting --> Completed

||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma
Trial completion:  Efficacy and Safety of KI1001 in ? 55 Years Old Insomnia Patients (clinicaltrials.gov) -  Apr 22, 2012
P3, N=170, Completed,  Sponsor: Kuhnil Pharmaceutical Co., Ltd.
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder (clinicaltrials.gov) - Apr 5, 2012
P=N/A, N=25, Completed, Sponsor: Department of Veterans Affairs
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Effects of Chronic Insomnia on the Neuroendocrine Regulation of Glucose and Lipid Metabolism (clinicaltrials.gov) - Mar 7, 2012
P0, N=25, Completed, Sponsor: University Hospital, Basel, Switzerland
Active, not recruiting --> Completed Recruiting --> Completed

|||||||||| Trial completion: Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease (clinicaltrials.gov) - Jan 11, 2012
P=N/A, N=132, Completed, Sponsor: University of Washington
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Trial completion: Effectiveness of Internet Cognitive Behavioral Therapy Intervention for Treating Insomnia (clinicaltrials.gov) - Jan 10, 2012
P1/2, N=44, Completed, Sponsor: University of Virginia
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  Belsomra (suvorexant) / Merck (MSD)
Trial completion:  Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study A (MK-4305-028) (clinicaltrials.gov) -  Jan 9, 2012
P3, N=1023, Completed,  Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed

||||||||||  piromelatine (Neu P11) / Neurim
New P2 trial:  Sleep Laboratory Study to Investigate the Safety and Efficacy of Neu-P11 in Primary Insomnia Patients (clinicaltrials.gov) -  Dec 8, 2011
P2, N=137, Completed,  Sponsor: Neurim Pharmaceuticals Ltd.

|||||||||| Enrollment open: SHUTi: An Interactive Internet Intervention for Adults With Insomnia (clinicaltrials.gov) - Oct 10, 2011
P3, N=300, Recruiting, Sponsor: University of Virginia
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  Circadin (melatonin prolonged release) / Lundbeck, Neurim, Flynn Pharma, Grupo Insud, Biocodex, Kuhnil Pharma
New P3 trial:  Efficacy and Safety of KI1001 in ? 55 Years Old Insomnia Patients (clinicaltrials.gov) -  Oct 5, 2011
P3, N=170, Completed,  Sponsor: Kuhnil Pharmaceutical Co., Ltd.

|||||||||| Enrollment change: Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing (clinicaltrials.gov) - Oct 4, 2011
P4, N=20, Completed, Sponsor: University of Rochester
Not yet recruiting --> Recruiting N=44 --> 20

||||||||||  zolpidem ER / Generic mfg.
Enrollment change:  A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients (clinicaltrials.gov) -  Oct 4, 2011
P4, N=132, Completed,  Sponsor: Astellas Pharma Inc
N=44 --> 20 N=180 --> 132

||||||||||  zolpidem ER / Generic mfg.
Trial completion:  A Study to Compare Efficacy and Safety of Zolpidem Modified Release Formulation Versus Zolpidem in Insomnia Patients (clinicaltrials.gov) -  Oct 4, 2011
P4, N=132, Completed,  Sponsor: Astellas Pharma Inc
N=180 --> 132 Recruiting --> Completed

||||||||||  zolpidem ER / Generic mfg.
Trial completion:  A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients (clinicaltrials.gov) -  Oct 4, 2011
P4, N=42, Completed,  Sponsor: Astellas Pharma Inc
Recruiting --> Completed Recruiting --> Completed

||||||||||  zaleplon / Generic mfg.
Trial completion:  Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 (clinicaltrials.gov) -  Sep 25, 2011
P2, N=67, Completed,  Sponsor: Somnus Therapeutics, Inc.
Recruiting --> Completed Active, not recruiting --> Completed

|||||||||| Enrollment change: Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder (clinicaltrials.gov) - Sep 21, 2011
P=N/A, N=25, Completed, Sponsor: Department of Veterans Affairs
Active, not recruiting --> Completed N=60 --> 25

|||||||||| New P3 trial: SHUTi: An Interactive Internet Intervention for Adults With Insomnia (clinicaltrials.gov) - Sep 19, 2011
P3, N=300, Recruiting, Sponsor: University of Virginia

|||||||||| Enrollment closed: A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD) (clinicaltrials.gov) - Aug 9, 2011
P=N/A, N=76, Active, not recruiting, Sponsor: University of Arizona
N=60 --> 25 Recruiting --> Active, not recruiting