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53 Mechanisms of Action

||||||||||  cyclosporin A microemulsion / Generic mfg.
New P2 trial:  CYPRESS: Low Dose Cyclosporin A in Primary Sjögren Syndrome (clinicaltrials.gov) -  Sep 24, 2012
P2, N=30, Recruiting,  Sponsor: Charite University, Berlin, Germany

||||||||||  clonidine/oxybutynin (OP-014) / Orient Europharma
Trial completion:  A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's Disease (clinicaltrials.gov) -  Sep 20, 2012
P2, N=24, Completed,  Sponsor: Orient Pharma Co., Ltd.
Recruiting --> Completed

||||||||||  selenomethionine (SLM) / University of Iowa, Holden Comprehensive Cancer Center
New P2 trial, Metastases:  Selenomethionine in Reducing Mucositis in Patients With Locally Advanced Head and Neck Cancer Who Are Receiving Cisplatin and Radiation Therapy (clinicaltrials.gov) -  Sep 6, 2012
P2, N=18, Completed,  Sponsor: Roswell Park Cancer Institute

||||||||||  Benlysta (belimumab) / GSK
Trial completion:  Efficacy and Safety of Belimumab in Primary Sj (clinicaltrials.gov) -  Sep 2, 2012
P2, N=15, Completed,  Sponsor: University of Udine
Recruiting --> Completed Recruiting --> Completed

||||||||||  dovitinib (TKI258) / Allarity Therap, Oncoheroes
New P2 trial, Metastases:  DOVE: A Phase II Study of Dovitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary Glands (clinicaltrials.gov) -  Aug 30, 2012
P2, N=20, Active, not recruiting,  Sponsor: Ontario Clinical Oncology Group (OCOG)

||||||||||  baminercept (BG 9924) / Biogen
Enrollment open:  Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sj (clinicaltrials.gov) -  Aug 15, 2012
P2, N=72, Recruiting,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Recruiting --> Completed Not yet recruiting --> Recruiting

||||||||||  dasatinib / Generic mfg.
Enrollment closed, Metastases:  Dasatinib in Treating Patients With Recurrent or Metastatic Malignant Salivary Gland Tumors (clinicaltrials.gov) -  Aug 14, 2012
P2, N=65, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting

||||||||||  MK-2206 / Merck (MSD)
Trial initiation date, Metastases:  Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma (clinicaltrials.gov) -  Aug 2, 2012
P2, N=15, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Initiation date: Oct 2011 --> Aug 2012

||||||||||  Xeomin (incobotulinumtoxinA) / Merz Pharma
New P2 trial:  Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism (clinicaltrials.gov) -  Jul 26, 2012
P2, N=20, Recruiting,  Sponsor: Beth Israel Deaconess Medical Center

|||||||||| New P2/3 trial: Drug-induced Xerostomia. Evaluation of Malic Acid 1%, Salivary Mucins and Buffering Capacity (clinicaltrials.gov) - Jul 25, 2012
P2/3, N=185, Recruiting, Sponsor: Universidad de Granada

|||||||||| New P1/2 trial: Green Tea Lozenges for the Management of Dry Mouth (clinicaltrials.gov) - Jul 22, 2012
P1/2, N=60, Recruiting, Sponsor: Georgia Regents University

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
New P1 trial, Metastases:  Cetuximab and Everolimus in Treating Patients With Metastatic or Recurrent Colon Cancer or Head and Neck Cancer (clinicaltrials.gov) -  Jul 9, 2012
P1, N=12, Completed,  Sponsor: Fox Chase Cancer Center

||||||||||  Benlysta (belimumab) / GSK
Enrollment change, IO biomarker:  BELISS: Efficacy and Safety of Belimumab in Subjects With Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P2, N=20, Completed,  Sponsor: Assistance Publique - H
Initiation date: Oct 2011 --> Aug 2012 N=15 --> 20

||||||||||  Benlysta (belimumab) / GSK
Trial completion, IO biomarker:  BELISS: Efficacy and Safety of Belimumab in Subjects With Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P2, N=20, Completed,  Sponsor: Assistance Publique - H
N=15 --> 20 Recruiting --> Completed

||||||||||  hydroxychloroquine / Generic mfg.
Trial completion:  JOQUER: Hydroxychloroquine Versus Placebo in Primary Sj (clinicaltrials.gov) -  Jun 30, 2012
P3, N=120, Completed,  Sponsor: Assistance Publique - H
Recruiting --> Completed Recruiting --> Completed

|||||||||| Clinical: Effect of 0.1% Pilocarpine Mouthwash on Xerostomia (clinicaltrials.gov) - Jun 24, 2012
P=N/A, N=60, Completed, Sponsor: Jeong-seong Kwon

||||||||||  Halaven (eribulin mesylate) / Eisai
New P2 trial, Metastases:  Eribulin Mesylate in Treating Patients With Recurrent or Metastatic Salivary Gland Cancer (clinicaltrials.gov) -  Jun 5, 2012
P2, N=29, Recruiting,  Sponsor: University of Washington

|||||||||| Trial completion, Surgery: Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer (clinicaltrials.gov) - May 31, 2012
P2, N=49, Completed, Sponsor: Radiation Therapy Oncology Group
Recruiting --> Completed Active, not recruiting --> Completed

||||||||||  MK-2206 / Merck (MSD)
New P2 trial, Metastases:  Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma (clinicaltrials.gov) -  May 22, 2012
P2, N=15, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)

||||||||||  hydroxychloroquine / Generic mfg.
New P3 trial:  Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome (clinicaltrials.gov) -  May 15, 2012
P3, N=39, Completed,  Sponsor: Seoul National University Hospital

|||||||||| Enrollment change: The Effect of Honey on Xerostomia and Oral Mucositis (clinicaltrials.gov) - Apr 25, 2012
P2, N=60, Recruiting, Sponsor: Cyprus University of Technology
Active, not recruiting --> Completed N=40 --> 60

||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
New P1/2 trial:  Rituximab in IgG4-RD: A Phase 1-2 Trial (clinicaltrials.gov) -  Apr 23, 2012
P1/2, N=30, Active, not recruiting,  Sponsor: Massachusetts General Hospital

|||||||||| Trial completion: OGT Spray in the Management of Xerostomia in the Elderly (clinicaltrials.gov) - Apr 19, 2012
P3, N=74, Completed, Sponsor: Laboratoires CARILENE
N=40 --> 60 Terminated --> Completed

|||||||||| Enrollment change: Acupuncture in Treating Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer (clinicaltrials.gov) - Apr 2, 2012
P3, N=240, Recruiting, Sponsor: M.D. Anderson Cancer Center
Terminated --> Completed N=150 --> 240

||||||||||  Xeomin (incobotulinumtoxinA) / Merz Pharma
New P2 trial:  Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Mar 25, 2012
P2, N=20, Recruiting,  Sponsor: Beth Israel Deaconess Medical Center

||||||||||  Myobloc (rimabotulinumtoxin B) / Supernus Pharma, Eisai
Trial completion:  Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) -  Mar 12, 2012
P2/3, N=20, Completed,  Sponsor: The University of Texas Health Science Center at San Antonio
N=150 --> 240 Active, not recruiting --> Completed

||||||||||  baminercept (BG 9924) / Biogen
New P2 trial:  Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sj (clinicaltrials.gov) -  Mar 11, 2012
P2, N=72, Recruiting,  Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

||||||||||  Botox (onabotulinumtoxin A) / GSK, AbbVie, Healis Therap
New P2 trial:  ALS-TOX: Toxin Treatment for Amyotrophic Lateral Sclerosis (ALS) Related Sialorrhea (clinicaltrials.gov) -  Mar 11, 2012
P2, N=90, Recruiting,  Sponsor: Hospices Civils de Lyon

|||||||||| New P2 trial, HEOR: TOQUAL: Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract (clinicaltrials.gov) - Mar 6, 2012
P2, N=44, Recruiting, Sponsor: Centre Francois Baclesse

||||||||||  ProQuad (measles, mumps, rubella and varicella virus vaccine live) / Merck (MSD)
New P3 trial:  Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027) (clinicaltrials.gov) -  Feb 20, 2012
P3, N=1413, Completed,  Sponsor: Merck Sharp & Dohme Corp.

|||||||||| Enrollment closed: Making Decisions About the Measles-Mumps-Rubella Vaccine (clinicaltrials.gov) - Feb 9, 2012
P=N/A, N=79, Active, not recruiting, Sponsor: University of Michigan
Active, not recruiting --> Completed Recruiting --> Active, not recruiting

||||||||||  Erbitux (cetuximab) / Eli Lilly, EMD Serono
Enrollment closed, IO biomarker, Metastases:  Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab (clinicaltrials.gov) -  Feb 6, 2012
P2, N=88, Active, not recruiting,  Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Suspended --> Active, not recruiting

||||||||||  Apolactoferrin (talactoferrin alfa) / Agennix, talactoferrin oral (oral rhLF) / Agennix
New P1 trial, Immunomodulating:  Talactoferrin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer or Squamous Cell Head and Neck Cancer (clinicaltrials.gov) -  Feb 5, 2012
P1, N=4, Terminated,  Sponsor: Stanford University

|||||||||| Trial initiation date: Proof-of-concept (PoC) Study of APD515 (clinicaltrials.gov) - Jan 11, 2012
P2, N=32, Completed, Sponsor: Acacia Pharma Ltd
Suspended --> Active, not recruiting Initiation date: Jun 2011 --> Sep 2011

||||||||||  amifostine / Generic mfg.
Trial termination:  Chemo/XRT +/- Amifostine to Assess Outcomes Related to Xerostomia, Mucositis, & Dysphagia (clinicaltrials.gov) -  Dec 6, 2011
P2, N=42, Terminated,  Sponsor: Vanderbilt-Ingram Cancer Center
Initiation date: Jun 2011 --> Sep 2011 Active, not recruiting --> Terminated; funding became unavailable

||||||||||  cisplatin / Generic mfg.
New P2 trial:  A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors (clinicaltrials.gov) -  Dec 6, 2011
P2, N=120, Recruiting,  Sponsor: King Faisal Specialist Hospital & Research Center

|||||||||| Trial completion: Effects of Mucoprotective Product on Xerostomia (clinicaltrials.gov) - Nov 7, 2011
P4, N=20, Completed, Sponsor: Camurus AB
Active, not recruiting --> Terminated; funding became unavailable Recruiting --> Completed

|||||||||| New P2 trial: The Effect of Honey on Xerostomia and Oral Mucositis (clinicaltrials.gov) - Nov 2, 2011
P2, N=60, Recruiting, Sponsor: Cyprus University of Technology

|||||||||| Enrollment change: Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure (clinicaltrials.gov) - Oct 5, 2011
P2, N=42, Completed, Sponsor: AHS Cancer Control Alberta
Recruiting --> Completed N=35 --> 42

|||||||||| Trial completion: Xerostomia in Head and Neck Cancer Patients Receiving Radiation as the Primary Treatment Versus Patients Who Will Not Have Such a Procedure (clinicaltrials.gov) - Oct 5, 2011
P2, N=42, Completed, Sponsor: AHS Cancer Control Alberta
N=35 --> 42 Active, not recruiting --> Completed

||||||||||  dexamethasone / Generic mfg.
Enrollment open:  Dexamethasone Irrigation of the Parotid Glands in Primary Sj (clinicaltrials.gov) -  Sep 11, 2011
P2, N=20, Recruiting,  Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Active, not recruiting --> Completed Not yet recruiting --> Recruiting

|||||||||| Enrollment change: Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome (clinicaltrials.gov) - Aug 30, 2011
P=N/A, N=28, Completed, Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
Not yet recruiting --> Recruiting N=60 --> 28

|||||||||| Trial completion: Evaluation of the Role of the Autonomic Nervous System in Sj(SqrRoot)(Delta)Gren s Syndrome (clinicaltrials.gov) - Aug 30, 2011
P=N/A, N=28, Completed, Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
N=60 --> 28 Recruiting --> Completed

|||||||||| Trial termination: Electroacupuncture in Treating Chronic Dry Mouth Caused By Radiation Therapy in Patients With Head and Neck Cancer (clinicaltrials.gov) - Aug 10, 2011
P=N/A, N=30, Terminated, Sponsor: Mayo Clinic
Recruiting --> Completed Recruiting --> Terminated; Slow accrual; did not meet accrual goal

|||||||||| New P3 trial: The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome (clinicaltrials.gov) - Aug 9, 2011
P3, N=70, Completed, Sponsor: West China Hospital