RPCEC00000343
Not yet recruiting
Phase 3
Phase III clinical trial, placebo-controlled, randomized and double-blind to assess the efficacy and safety of NeuroEPO nasal administration in adult patients with spinocerebellar ataxias. - NESCA
Center of Molecular Immunology (CIM)0 sites80 target enrollmentStarted: November 19, 2020Last updated:
ConditionsSpinocerebellar AtaxiaSpinocerebellar AtaxiasCerebellar AtaxiaAtaxiaSpinocerebellar DegenerationsCerebellar DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornBrain Diseases
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Center of Molecular Immunology (CIM)
- Enrollment
- 80
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
Eligibility Criteria
- Ages
- 18 years to 70 years (—)
- Sex
- All
Inclusion Criteria
- •1\. otal SARA scale score between 3 and 14 points.
- •2\. Ages between 18 and 70 years (inclusive).
- •3\. Expresses in writing your consent to participate in the study.
Exclusion Criteria
- •1\. Suffering from decompensated chronic diseases (Cardiopathies, Diabetes Mellitus, Arterial Hypertension, Chronic Renal Failure, Bronchial Asthma, etc.).
- •2\. Parkinson's manifestations and/or frontotemporal dementia.
- •3\. History of any other degenerative or systemic neurological disease with an impact on the nervous system.
- •4\. History of psychiatric illnesses.
- •5\. Known bleeding disorders or active bleeding.
- •6\. Patient who is being treated with anti\-aguerants or anticoagulants.
- •7\. Severe acute diseases at the time of inclusion.
- •8\. Pregnant or lactating woman.
- •9\. Patient with reproductive and sexually active capacity who does not agree to use at least one effective method of contraception prior to inclusion in the study and/or during participation in the clinical trial (in the case of the female sex: intrauterine devices, barrier methods, hormones or tubal ligation and in the case of the male sex: vasectomy, condom use).
- •10\. Hypersensitivity to the active substance (recombinant human erythropoietin) or to any of the active substances that make up the product.
Investigators
Similar Trials
Not yet recruiting
Phase 3
Phase III clinical trial: Dermofural®. Mild infection in diabetic foot ulcerDiabetic foot ulcer with mild infectionDiabetic FootFoot UlcerDiabetic AngiopathiesDiabetic NeuropathiesDiabetes MellitusDiabetes ComplicationsLeg UlcerEndocrine System DiseasesSkin UlcerVascular DiseasesCardiovascular DiseasesRPCEC00000423Chemical Bioactive Center
Completed
Not Applicable
Clot lysis: evaluating accelerated resolution of intraventricular haemorrhage Phase IIIIntraventricular haemorrhage (IVH) or IVH with intracerebral haemorrhage (ICH)Circulatory SystemIntracerebral haemorrhageISRCTN70157009Individual Sponsor (USA)500
Active, not recruiting
Phase 1
A study to compare the use of Arimoclomol with placebo in patients withAmyotrophic Lateral SclerosisEUCTR2018-000137-13-ITORPHAZYME APS231
Active, not recruiting
Phase 1
A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisMedDRA version: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2018-000137-13-BEOrphazyme A/S231
Active, not recruiting
Phase 1
A study to compare the use of Arimoclomol with placebo in patients with Amyotrophic Lateral SclerosisAmyotrophic Lateral SclerosisMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2018-000137-13-NLOrphazyme A/S231