Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02012114 : A Cohort of Patients With Cystinosis : Compliance to Cysteamine and Neurological Complications
PhaseN/A
AgesMin: 4 Years Max: N/A
Eligibility
- Male and female subjects with confirmed diagnosis of nephropathic cystinosis (defined
by clinical signs and WBC cystine level).

- Age > 4 years.

- Subjects receiving any oral cysteamine treatment: Cystagon or RP103.

- Sexually active female subjects of childbearing potential must agree to utilize the
same acceptable form of contraception from day 1 through completion of the study.

- Subjects or their parent or legal guardian must provide written informed consent
prior to participation in the study.

- Subjects covered by or having the right to social security.

Exclusion Criteria:

- Subjects with known hypersensitivity to cysteamine and penicillamine.

- Females who are nursing, planning a pregnancy, known or suspected to be pregnant, or
with a positive urinary pregnancy test.

- Subjects who, in the opinion of the Investigator, are not able or willing to comply
with the protocol.

- Contra-indication to MRI assessment

CONTROLS FOR METABONOMIC ASSESSMENTS

Inclusion Criteria:

- Age and sex matched to study population: Age range: patients aged 4 to 5 years, 6 to 11
years, patients aged 12 to 17 years, adult patients: 18 or above.

Sex: male or female

- Subjects or their parent or legal guardian must provide written informed consent
prior to participation in the study.

- Subjects covered by or having the right to social security.

Exclusion Criteria:

- Any uropathology or nephropathology.

CONTROLS FOR NMRS ASSESSMENTS

Inclusion Criteria:

- Age and sex matched to study population: Age range: patients aged 4 to 5 years, 6 to 11
years, patients aged 12 to 17 years, adult patients: 18 or above.

Sex: male or female

- Subjects or their parent or legal guardian must provide written informed consent
prior to participation in the study.

- Subjects covered by or having the right to social security.

Exclusion Criteria:

- Any uropathology or nephropathology.

- Any neurological and/or psychiatric disorder

- Contra-indication to MRI assessment.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02012114      |      Link to official Clinicaltrials.gov listing
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