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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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19 March 2012 |
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Main ID: |
EUCTR2006-000614-21-IT |
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Date of registration:
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05/10/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria - ND
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Scientific title:
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A multicentre, open-label study to evaluate the efficacy and safety of 5-MTHF administration, added on to the individual established therapy, on plasma homocysteine levels in patients with congenital homocystinuria - ND |
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Date of first enrolment:
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11/12/2006 |
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Target sample size:
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22 |
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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:2006-000614-21 |
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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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Countries of recruitment
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Austria
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Hungary
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Italy
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
signed informed consent (patient and countersigned by Legal responsible in case of patients below age of consent);
≥16 years of age;
classical (non-pyridoxine responsive) homocystinuria (CBS deficiency);
stable clinical condition;
willing to complete all phases and all procedures of the study;
on B6, B12 and betaine and FA treatment;
ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study.
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:
anticipated need of multivitamin supplements, folic acid or creatine treatment throughout the duration of the study
episodes of thrombosis and/or embolism one year before inclusion in the study
history of drug and/or alcohol abuse with 6 months of baseline
serious undercurrent illness(as) or diseases (e.g., haematological, renal, hepatic, respiratory, endocrine, psychiatric) that may interfere with, or put patients at additional risk for their ability to receive the treatment outlined in the protocol
donation or receipt of blood or blood products (within 2 months before baseline)
pregnant or lactating female
Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the start of the study
substantial changes in eating habits within the past 4 weeks.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Homocystinuria
MedDRA version: 6.1
Level: PT
Classification code 10020365
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Intervention(s)
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Trade Name: PREFOLIC 15*30CPR GASTROR 15MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Detoxifying agents for antineoplastic treatment
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
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Primary Outcome(s)
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Primary end point(s): Reduction from baseline of tHcy in plasma induced by 3 months treatment with 5-MTHF 15 mg. Baseline will be defined as the tHcy levels observed after the wash-out phase, before 5-MTHF first intake.
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Secondary Objective:
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Main Objective: To investigate the efficacy and safety of a 3 month 5-MTHF treatment in terms of decreasing total plasma homocysteine (tHcy) in homocystinuric patients, while co-administered with an individual established therapy as a folic acid substitute.
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Secondary ID(s)
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2006-000614-21-AT
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CRO-05-73-7168K01
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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