Dexdor ( DrugBank: - )

4 diseases
告示番号疾患名（ページ内リンク）臨床試験数
2筋萎縮性側索硬化症1
4原発性側索硬化症1
6パーキンソン病2
70広範脊柱管狭窄症2

2. 筋萎縮性側索硬化症

臨床試験数 : 645 /  薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2018-000142-18-FI
(EUCTR)		09/05/201808/05/2018Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative careFeasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care Amyotrophic lateral sclerosis (ALS)
MedDRA version: 20.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Trade Name: Ketanest-S
INN or Proposed INN: ESKETAMINE		Turku University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		20Phase 4Finland

4. 原発性側索硬化症

臨床試験数 : 5 /  薬物数 : 13 - (DrugBank : 6) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 25
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2018-000142-18-FI
(EUCTR)		09/05/201808/05/2018Feasibility and effects of subcutaneously given combination of dexmedetomidine and ketamine in ALS patients receiving palliative careFeasibility and pharmacodynamics of subcutaneously given combination of dexmedetomidine and ketamine infusion in ALS patients receiving palliative care Amyotrophic lateral sclerosis (ALS)
MedDRA version: 20.1;Level: LLT;Classification code 10036704;Term: Primary lateral sclerosis;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Trade Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Trade Name: Ketanest-S
INN or Proposed INN: ESKETAMINE		Turku University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		20Phase 4Finland

6. パーキンソン病

臨床試験数 : 2,307 /  薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2016-002680-34-ES
(EUCTR)		20/10/201605/08/2016Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease. Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]		Trade Name: Dexdor
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Other descriptive name: DEXMEDETOMIDINA		Clínica Universidad de Navarra/Universidad de NavarraNULLNot RecruitingFemale: yes
Male: yes		12Phase 4Spain
2EUCTR2014-000868-17-ES
(EUCTR)		26/06/201417/03/2014Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulatorsEffect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators Parkinson's disease
MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]		Trade Name: Dexdor
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Other descriptive name: DEXMEDETOMIDINA
Trade Name: Propofol-Lipuro
Product Name: Propofol-Lipuro
INN or Proposed INN: PROPOFOL
Other descriptive name: PROPOFOL		Clínica Universidad de Navarra/Universidad de NavarraNULLNot RecruitingFemale: yes
Male: yes		Spain

70. 広範脊柱管狭窄症

臨床試験数 : 95 /  薬物数 : 169 - (DrugBank : 61) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 90
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2015-002694-37-FI
(EUCTR)		01/09/201604/01/2016Dexmedetomidine is a drug that is used mainly for sedation in the intensive care unit. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. DEXPAIN-study has been approved by Kuopio university hospitals ethics committee.Dexmedetomidine infusion in pain management during low back surgeryDexmedetomidine is an alpha-2-adrenergic agonist that is used mainly for sedation in the intensive care unit. Alpha-2-adrenoceptors agonists have several beneficial actions in a surgical patient. They decrease symphatetic tone, reduce anesthetic and opioid requirements and cause sedation and analgesia. Pain after low back surgery is intense and can become chronic. We need a new drug to manage pain during postoperative period and to prevent chronic pain.DEXPAIN-study has been approved by Kuopio university hospitals ethics committee. Study is single centered, randomized and placebo-controlled study. A total of 60 patients scheduled for low back surgery will be enrolled in this study. Patients eligibility will be assessed by pre-determined inclusion-exclusion-criteria. Purpose of this study is to determine does Dexmedetomidine infusion provide pain management in the postoperative period and prevent chronic pain. Patients are randomized to receive either placebo or dexmedetomidine infusion. Patients in the dexmedetomidine group receive dexmedetomidine loading dose 1ug/kg for 10 minutes and continuous infusion 1.4 ug/kg/h during surgery and post-anesthesia care unit. Total infusion time will be four hours. Anesthesia is standardized and post-operative pain is treated with patient controlled analgesia made of oxycodone. Questionnaires will be used to assess pain control.Study is scheduled to start as soon as we obtain permission from Finnish Medicines Agency and receive sufficient funding. Low back pain, Discus prolapse, Spinal stenosis;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Trade Name: Dexmedetomidine
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE		Kuopio University hospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes		Finland
2EUCTR2014-003252-31-FI
(EUCTR)		15/05/201522/04/2015Dose-response of dexmedetomidine in patient controlled analgesia in orthopaedic surgery patientsDose response study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in orthopaedic spine surgery patients - DoserespDex_2.0 Patients, who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation
MedDRA version: 17.1;Level: LLT;Classification code 10041595;Term: Spinal stenosis lumbar;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]		Trade Name: Dexdor
INN or Proposed INN: deksmedetomidiini
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Trade Name: Oxanest
INN or Proposed INN: oksikodoni
Other descriptive name: OXYCODONE HYDROCHLORIDE		University of TurkuNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		Finland

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