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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2006-006845-14-FR |
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Date of registration:
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15/02/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open-label Phase 1b, Dose-ranged, Single and Multiple Dose Study to assess Safety and Pharmacokinetics of TRO19622 in 6-25 year old Spinal Muscular Atrophy (SMA) patients.
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Scientific title:
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Open-label Phase 1b, Dose-ranged, Single and Multiple Dose Study to assess Safety and Pharmacokinetics of TRO19622 in 6-25 year old Spinal Muscular Atrophy (SMA) patients. |
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Date of first enrolment:
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20/03/2007 |
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Target sample size:
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20 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006845-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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France
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients with SMA type Ib, II or III
Between 6-25 years old
Having a "Motor Function Measure" (MFM) score superior or equal to 12
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Concomitant treatments with drugs being investigated in a clinical trial or with drugs likely to interfere with TRO19622 absorption (ezetimibe, fibrates)
Associated diseases (cardiovascular disorders, hemostasis disorders, renal insufficiency or confirmed hepatic insufficiency)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Spinal Muscular Atrophy (SMA)
MedDRA version: 9.1
Level: LLT
Classification code 10041582
Term: Spinal muscular atrophy
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Intervention(s)
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Product Code: TRO19622
Pharmaceutical Form: Capsule*
CAS Number: 22033-87-0
Current Sponsor code: TRO19622
Other descriptive name: 4-cholesten-3-one,oxime
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 125-250
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Primary Outcome(s)
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Main Objective: Pharmacokinetic
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Primary end point(s): Safety and pharmacokinetic
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Secondary Objective: Safety
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Secondary ID(s)
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TRO19622 CL E Q 1115-1
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 20/03/2007
Contact:
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