AZD3241 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
6Parkinson disease5
17Multiple system atrophy7

6. Parkinson disease


Clinical trials : 2,298 Drugs : 2,202 - (DrugBank : 350) / Drug target genes : 188 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01603069
(ClinicalTrials.gov)
October 201214/5/2012A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseA Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: PlaceboAstraZenecaNULLCompleted30 Years80 YearsBoth51Phase 2United States
2EUCTR2011-004803-19-FI
(EUCTR)
16/08/201216/05/2012PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
3NCT01527695
(ClinicalTrials.gov)
April 201222/12/2011PET Study in Parkinson's Disease PatientsA Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mgAstraZenecaNULLCompleted45 Years75 YearsBoth24Phase 2Sweden
4EUCTR2011-004803-19-SE
(EUCTR)
22/02/201216/12/2011PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
5NCT01457807
(ClinicalTrials.gov)
November 201110/10/2011To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersA Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female VolunteersParkinson's DiseaseDrug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AstraZenecaNULLCompleted30 Years65 YearsBoth24Phase 1United Kingdom

17. Multiple system atrophy


Clinical trials : 118 Drugs : 163 - (DrugBank : 49) / Drug target genes : 61 - Drug target pathways : 112
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02388295
(ClinicalTrials.gov)
April 27, 20159/3/2015AZD3241 PET MSA Trial, Phase 2, Randomized,12 Week Safety and Tolerability Trial With PET in MSA PatientsA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects With Multiple System AtrophyMultiple System Atrophy, MSADrug: AZD3241;Drug: PlaceboAstraZenecaNULLCompleted30 Years80 YearsAll59Phase 2United States;Austria;Finland;France;Italy;Sweden;United Kingdom
2EUCTR2014-004902-13-SE
(EUCTR)
14/04/201502/01/2015Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 100mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: IUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
Product Name: AZD3241 300mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
64Phase 2France;United States;Finland;Austria;Italy;United Kingdom;Sweden
3EUCTR2014-004902-13-GB
(EUCTR)
09/04/201524/12/2014Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 100mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: IUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
Product Name: AZD3241 300mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
AstraZeneca ABNULLNot Recruiting Female: yes
Male: yes
64 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Finland;United Kingdom;Sweden
4EUCTR2014-004902-13-FI
(EUCTR)
11/02/201531/12/2014Study to assess the effect of AZD3241 in Multiple System AtrophyA 12-Week, Multicenter, Randomized, Parallel-Group Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy Multiple system atrophy (MSA)
MedDRA version: 18.1;Level: PT;Classification code 10064060;Term: Multiple system atrophy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 100mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: IUPAC name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
Product Name: AZD3241 300mg
Product Code: AZD3241
INN or Proposed INN: Not available
Other descriptive name: 1-(2-Isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d] pyrimidin-4-one
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
64Phase 2United States;France;Finland;Austria;United Kingdom;Italy;Sweden
5EUCTR2009-018157-23-GB
(EUCTR)
30/11/201016/06/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System Atrophy Multiple system atrophy
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
135Phase 2United Kingdom;Spain;Austria
6EUCTR2009-018157-23-AT
(EUCTR)
11/11/201007/07/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, 12-Month Treatment, Adaptive Design Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System Atrophy Multiple system atrophy
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United Kingdom;Spain;Austria
7EUCTR2009-018157-23-ES
(EUCTR)
14/09/201023/06/2010A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyEstudio de fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de gruposparalelos, de 12 meses de duración para evaluar la eficacia, la seguridad, la tolerabilidad y lafarmacocinética de AZD3241 en pacientes con atrofia multisistémicaA Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System AtrophyEstudio de fase IIa, multicéntrico, doble ciego, aleatorizado, controlado con placebo, de gruposparalelos, de 12 meses de duración para evaluar la eficacia, la seguridad, la tolerabilidad y lafarmacocinética de AZD3241 en pacientes con atrofia multisistémica Multiple system atrophyAtrofia Multisistémica
MedDRA version: 12.1;Level: LLT;Classification code 10064060;Term: Multiple system atrophy
Product Name: AZD3241
Product Code: AZD3241
Product Name: AZD3241
Product Code: AZD3241
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110Phase 2United Kingdom;Spain;Austria