Phase
Condition
Warts
Neurofibromatosis
Brain Tumor
Treatment
N/AClinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years at the time of inclusion.
Signed and dated written informed consent in accordance with ICH-GCP and local lawprior to inclusion in the study.
NF1 diagnosed (according to the international consensus criteria for evaluating NF1 [18]), see Appendix A.
Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographicfindings).
Existing of PN-associated symptoms.
Adult patients (≥18 years) with newly diagnosed PN or established PN naïve toMEK-inhibitor therapy verified by medical records/histories (e.g., priorprescriptions, hospitalization data).
Exclusion
Exclusion Criteria:
The participation in any clinical study currently (patients participating in othernon-interventional studies may be included);
Patients with the evidence of a malignant glioma, malignant peripheral nerve sheathtumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.
In the opinion of the investigator the patient is not able to return for follow-upvisits or obtain required follow-up studies.
Individuals who are pregnant or breast feeding or who become pregnant while enrolledon this trial, if they are unable to undergo radiographic evaluations or MRI scansrequested for research purposes, or other studies which might negatively impact onthe pregnancy.
Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screeningor initiation of therapy prior to age 18 verified by medical records/histories (e.g., prior prescriptions, hospitalization data).
Patients who modify their index pathogenetic therapy regimen during the study (forexample, pathogenetic antitumor therapy of PN; switching to a different therapy), asdetermined by the investigator at any protocol-specified visit during the a study,will be excluded from the primary efficacy analysis population from the point ofmodification onward and will not continue study participation.
Study Design
Study Description
Connect with a study center
Research Site
Arkhangelsk,
RussiaActive - Recruiting
Research Site
Arkhangelsk 581049,
RussiaSite Not Available
Research Site
Chelyabinsk,
RussiaActive - Recruiting
Research Site
Chelyabinsk 1508291,
RussiaSite Not Available
Research Site
Krasnoyarsk,
RussiaActive - Recruiting
Research Site
Krasnoyarsk 1502026,
RussiaSite Not Available
Research Site
Kurgan,
RussiaActive - Recruiting
Research Site
Moscow,
RussiaActive - Recruiting
Research Site
Moscow 524901,
RussiaSite Not Available
Research Site
Nizhny Novgorod,
RussiaActive - Recruiting
Research Site
Nizhny Novgorod 520555,
RussiaSite Not Available
Research Site
Novosibirsk,
RussiaActive - Recruiting
Research Site
Novosibirsk 1496747,
RussiaSite Not Available
Research Site
Orenburg,
RussiaActive - Recruiting
Research Site
Saint Petersburg 498817,
RussiaSite Not Available
Research Site
Saint-Peretsburg,
RussiaActive - Recruiting
Research Site
Samara,
RussiaActive - Recruiting
Research Site
Samara 499099,
RussiaSite Not Available
Research Site
Tomsk,
RussiaActive - Recruiting
Research Site
Tomsk 1489425,
RussiaSite Not Available
Research Site
Ufa,
RussiaActive - Recruiting
Research Site
Ufa 479561,
RussiaSite Not Available
Research Site
Yekaterinburg,
RussiaActive - Recruiting
Research site
Yekaterinburg 1486209,
RussiaSite Not Available
Research site
Moscow,
Russian FederationSite Not Available

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