Clinical trials: Dystrophia Myotonica
Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast
Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib
Patients with advanced HER2+ breast cancer on maintenance trastuzumab/pertuzumab or T-DM1 with 1st or 2nd intracranial disease event (brain metastases) and stable extracranial disease will be enrolled.
- Conditions
- Brain Metastases, Human Epidermal Growth Factor 2 Positive Carcinoma of Breast, Advanced Breast Cancer
- Trial name
- BRIDGET (NCT05323955)
- Testing
- Trastuzumab, Trastuzumab Emtansine (T-DM1), Pertuzumab
- Where
- 8 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carey Anders, M.D.
Type 1 Diabetes, Adolescent Development
Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus.
The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative.
- Trial name
- NCT06331429
- Testing
- EmoTiCare
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- University of Valencia
Diabetes
Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
The aim of the TELESAGE study is to demonstrate 1. the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a…
- Trial name
- TELESAGE (NCT02287532)
- Testing
- DIABEO software
- Where
- 108 sites in France
- Volunteers
- 667 people
- Sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Congenital Myotonic Dystrophy, CDM
DMCRN-02-001: Assessing Pediatric Endpoints in DM1
The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition.
- Trial name
- ASPIRE-DM1 (NCT05224778)
- Where
- 5 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- Virginia Commonwealth University
Metastatic Breast Cancer
A Study of Trastuzumab-MCC-DM1 in Patients With HER2- Positive Locally Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, single-arm, expanded access study designed to provide T-DM1 to patients with HER2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of T-DM1…
- Trial name
- NCT01120561
- Testing
- trastuzumab-MCC-DM1
- Where
- 15 sites in United States
- Sponsor
- Genentech, Inc.
Myotonic Dystrophy 1, Muscular Dystrophies
Myotonic Dystrophy Type 1 Aerobic Exercise Study
Myotonic dystrophy type 1 (DM1) is a genetic disease that primarily targets skeletal muscle resulting in severe weakness and muscle loss.
- Trial name
- DM1ex (NCT04187482)
- Testing
- Exercise training
- Where
- Canada
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- McMaster University
Myotonic Dystrophy, Type 1 (DM1), Myotonic Dystrophy
Safety, Tolerability and Pharmacokinetics of ERX-963 in Adults With Myotonic Dystrophy Type 1
Participants in this study will receive two treatments, placebo and ERX-963, on different days in a randomized fashion. The primary purpose of this study is to investigate the safety and tolerability of ERX-963 in participants…
- Trial name
- NCT03959189
- Testing
- ERX-963
- Where
- 4 sites in United States
- Volunteers
- 12 people
- Sponsor
- Expansion Therapeutics, Inc.
HER2-positive Breast Cancer
A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
- Trial name
- A166 (NCT06968585)
- Testing
- A166, T-DM1
- Where
- China
- Volunteers
- 365 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Steinert Myotonic Dystrophy
Longitudinal Evaluation of Neuromuscular Involvement in Type 1 Myotonic Dystrophy
Primary objective: To determine the sensitivity to change of neuromuscular functional outcomes during the natural (non-interventional) progression of myotonic dystrophy type 1 (DM1), in order to identify the most relevant and…
- Trial name
- NatHis DM1 (NCT07362316)
- Testing
- Quantification of myotonia, MyoAnkle, Measurement of exercise-induced fatigue
- Where
- 2 sites in Canada, France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut de Myologie, France
HER2-positive Breast Cancer
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after…
- Trial name
- NCT06830889
- Testing
- BL-M07D1, T-DM1
- Where
- 2 sites in China
- Volunteers
- 1,450 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Myotonic Dystrophy 1
Chinese Multicenter Clinical Outcome Cohort Study of Myotonic Dystrophy Type 1 (C-DMCOS-DM1)
Myotonic dystrophy type 1 (DM1) is an autosomal dominant multisystem disorder caused by an expanded CTG trinucleotide repeat in the 3' untranslated region of the DMPK gene.
- Trial name
- C-DMCOS-DM1 (NCT06101940)
- Testing
- MRI scan, Electrocardiography, Pulmonary function test
- Where
- 22 sites in China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Huashan Hospital
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus…
- Trial name
- NCT01120184
- Testing
- docetaxel, paclitaxel, pertuzumab
- Where
- 257 sites in United States, Argentina and 36 more
- Volunteers
- 1,095 people
- Sponsor
- Hoffmann-La Roche
Myotonic Dystrophy Type 2
Clinical Outcome Measures in Myotonic Dystrophy Type 2
A monocentric, longitudinal, observational case-control study in patients with Myotonic Dystrophy type 2 (DM2). At least 60 DM2 will be evaluated through a battery of patients reported Outcomes (PROs) and clinical Outcome…
- Trial name
- COMEDY-2 (NCT03603171)
- Testing
- DM1-ActivC, R-PAct, Beck depression inventory
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Prof. Dr. Benedikt Schoser
Breast Cancer
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with…
- Trial name
- NCT05755048
- Testing
- Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
- Where
- 56 sites in China
- Volunteers
- 314 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Breast Neoplasm
A Study of Ado-trastuzumab Emtansine (T-DM1)-Induced Peripheral Neuropathy in HER2-positive Breast Cancer Patients
Researchers plan to study the natural history of ado-trastuzumab emtansine (T-DM1)-induced neuropathy both in patients without any history of neuropathy or previous neurotoxic agent use and in patients who have such a history.
- Trial name
- NCT05889988
- Where
- 21 sites in United States
- Volunteers
- 36 people
- Sponsor
- Mayo Clinic
Breast Cancer
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: cannot be removed by an operation has spread to other parts of the body
- Trial name
- NCT03523585
- Testing
- Trastuzumab deruxtecan, Capecitabine, Lapatinib
- Where
- 227 sites in United States, Australia and 13 more
- Volunteers
- 608 people
- Sponsor
- Daiichi Sankyo
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by…
- Trial name
- NCT00875979
- Testing
- Trastuzumab emtansine [Kadcyla] 3.0 mg/kg, Trastuzumab emtansine [Kadcyla] 3.6 mg/kg, Pertuzumab 420 mg
- Where
- 20 sites in United States, Belgium and 5 more
- Volunteers
- 67 people
- Sponsor
- Hoffmann-La Roche
Myotonic Dystrophy 1
Study of ATX-01 in Participants With DM1
The goal of this clinical trial is to test ATX-01 in participants with myotonic dystrophy type 1 (DM1). The main question it aims to answer is if ATX-01 is safe and well tolerated.
- Trial name
- ArthemiR (NCT06300307)
- Testing
- ATX-01
- Where
- 12 sites in United States, Canada and 5 more
- Volunteers
- 56 people
- Sponsor
- ARTHEx Biotech S.L.
HER-2 Positive Breast Cancer
HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent (maytansine derivate) has shown an encouraging antitumor…
- Trial name
- ZEPHIR (NCT01565200)
- Testing
- T-DM1, 89Zr-trastuzumab
- Where
- 5 sites in Belgium, Netherlands
- Volunteers
- 90 people
- Sponsor
- Jules Bordet Institute
Muscular Dystrophy, Arrhythmia
Arrhythmias in Myotonic Muscular Dystrophy
Adult myotonic muscular dystrophy (Steinert's disease) is the most common inherited neuromuscular disorder. Cardiac rhythm disturbances occur frequently in this disease state and may be responsible for up to one-third of deaths.
- Conditions
- Muscular Dystrophy, Arrhythmia, Sudden Cardiac Death
- Trial name
- DM1 (NCT00622453)
- Testing
- Screening
- Where
- United States
- Volunteers
- 448 people
- Sponsor
- Indiana University