Clinical trials: ISM
Sleep Disorder
Melatonin CR for the Treatment of Impaired Sleep Maintenance in 4-8 Year Old Children With Autism Spectrum Disorders
The purpose of this research is to see the effects (good and bad) of Melatonin CR on sleep in 4-8 year old children with autism spectrum disorders and sleep problems.
- Trial name
- NCT01033565
- Testing
- Natrol
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Nebraska
Indolent Systemic Mastocytosis
A Non-Interventional Study in Participants With Indolent Systemic Mastocytosis (ISM) in Germany
This is a non-interventional study assessing the effectiveness of avapritinib (BLU-285) in the management of ISM in real-world settings in Germany.
- Trial name
- NCT07255638
- Testing
- Avapritinib
- Where
- 12 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Blueprint Medicines Corporation
Schizophrenia
Comparative Bioavailability of Risperidone.
This is an Open-Label, One-Sequence Study to Evaluate the Steady- State Comparative Bioavailability of Intramuscular Risperidone ISM® and EU Risperdal® (Sourced From Germany).
- Trial name
- NCT05179525
- Testing
- Risperidone ISM® 100 mg, Risperdal 4mg Tablet
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Schizophrenia
Non-interventional Study of Risperidone ISM® in Schizophrenia Patients Hospitalised Due to a Relapse
This is a prospective, non-interventional, multicentre study designed to collect information about the effectiveness, safety and tolerability of Risperidone ISM in patients diagnosed with schizophrenia who are suffering an acute…
- Trial name
- RESHAPE (NCT05480046)
- Testing
- Risperidone ISM
- Where
- 77 sites in Germany, Italy and 3 more
- Volunteers
- 275 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Indolent Systemic Mastocytosis
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis
The objective of this study is to compare the safety and efficacy of masitinib (AB1010) to placebo in patients with mastocytosis with handicap.
- Trial name
- AB06006 (NCT00814073)
- Testing
- Masitinib, Best Supportive Care
- Where
- 24 sites in United States, France
- Volunteers
- 135 people
- Sponsor
- AB Science
Recurrent Glioblastoma
Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma
A study to determine the feasibility and safety of individualized cancer stem cell targeted therapy based on high-throughput functional profiling of FDA/EMA-approved drugs in patients with GBM that has recurred or progressed…
- Trial name
- ISM-GBM (NCT05043701)
- Testing
- Personalized drug combination
- Where
- Norway
- Volunteers
- 15 people
- Sponsor
- Oslo University Hospital
Schizophrenia
Comparative Bioavailability of Risperidone
This is an open-label, one sequence study to evaluate the steady-state comparative bioavailability of 100 mg Risperidone ISM® injectable every 4 weeks compared to once daily 4 mg oral risperidone in subjects with schizophrenia…
- Trial name
- NCT03527186
- Testing
- Risperidone ISM® 100 mg
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Schizophrenia
Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension
This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously…
- Trial name
- PRISMA-3_OLE (NCT03870880)
- Testing
- Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Where
- 24 sites in United States, Ukraine
- Volunteers
- 215 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Mastocytosis
Hydroxychloroquine in Isolated Cutaneous Mastocytosis Patients or Indolent Systemic Mastocytosis With Associated Skin Involvement Patients
The treatment of systemic mastocytosis has two main axes: Control of mast cell activation symptoms and The control of proliferation (accumulation) of mast cells.
- Trial name
- HCQMa (NCT05084872)
- Testing
- Hydroxychloroquine
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Cutaneous Mastocytosis, Indolent Systemic Mastocytosis
Adaptation of the Questionnaire "Regarding Patient's Quality of Life With Mastocytosis" in the French Language
Mastocytosis is a heterogeneous rare disease. A 27-item questionnaire to assess the quality of life of patients with cutaneous/ indolent systemic mastocytosis was developed in the German language and validated in the English…
- Trial name
- Mc_QoL (NCT03632811)
- Testing
- A structured interview with every patient
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Toulouse
Mastocytosis, Systemic
Avapritinib Rollover Study
The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.
- Trial name
- NCT06748001
- Testing
- Avapritinib
- Where
- 7 sites in Belgium, Canada and 4 more
- Volunteers
- 60 people
- Sponsor
- Blueprint Medicines Corporation
Indolent Systemic Mastocytosis, Smoldering Systemic Mastocytosis
(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis
This is a randomized, double-blind, placebo-controlled, Phase 2/3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic…
- Trial name
- NCT04910685
- Testing
- Elenestinib
- Where
- 88 sites in United States, Argentina and 23 more
- Volunteers
- 534 people
- Sponsor
- Blueprint Medicines Corporation
Indolent Systemic Mastocytosis
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment
The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell…
- Trial name
- NCT04333108
- Testing
- Masitinib, Best Supportive Care
- Where
- 17 sites in France, Germany and 6 more
- Volunteers
- 140 people
- Sponsor
- AB Science
Angioedema, Angioedemas, Hereditary
Angioedema Biomarker Research Study
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema…
- Conditions
- Angioedema, Angioedemas, Hereditary, Urticaria, Mastocytosis
- Trial name
- NCT06210698
- Testing
- Venipuncture
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Foundation For Rare Disease Research
SSM, Mastocytosis, Indolent
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis
This is a multi-part, randomized, double-blind, placebo-controlled Phase 2 clinical study comparing the safety and efficacy of bezuclastinib (CGT9486) plus best supportive care (BSC) with placebo plus BSC in patients with…
- Conditions
- SSM, Mastocytosis, Indolent, Mastocytosis, Systemic, Mastocytosis
- Trial name
- NCT05186753
- Testing
- Bezuclastinib Tablets (Formulation A), Bezuclastinib Tablets (Formulation B)
- Where
- 57 sites in United States, Australia and 13 more
- Volunteers
- 237 people
- Sponsor
- Cogent Biosciences, Inc.
Indolent Systemic Mastocytosis
(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis
This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose…
- Trial name
- NCT03731260
- Testing
- Avapritinib
- Where
- 49 sites in United States, Belgium and 11 more
- Volunteers
- 251 people
- Sponsor
- Blueprint Medicines Corporation
Healthy
Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®
The study will comprise two dosing periods in two different cohorts of healthy volunteers. The investigators will begin with a single dosage period I (1 injection of 25 mg of Risperidone for each subject); single dosage period…
- Trial name
- NCT01320410
- Testing
- ISM®
- Volunteers
- healthy volunteers welcome
- Sponsor
- Rovi Pharmaceuticals Laboratories
Healthy
Evaluation of IM Letrozole ISM® Pharmacokinetics, Safety, and Tolerability in Healthy Post-menopausal Women (LISA-1)
This is a Phase I, open label, dose escalation study designed to evaluate the pharmacokinetics, safety, and tolerability of single intramuscular injections of Letrozole ISM® at different strengths in voluntary healthy post…
- Trial name
- NCT03401320
- Testing
- Letrozole ISM
- Where
- Czechia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Rovi Pharmaceuticals Laboratories
Obesity & Overweight, Sleeve Gastrectomy
Istmin Levels in Laparoscopik Sleeve Gastrectomy
Obesity is a multifactorial disease which has become a public health problem with increasing frequency, especially in recent years.
- Conditions
- Obesity & Overweight, Sleeve Gastrectomy, Adipokines
- Trial name
- NCT07335549
- Testing
- Preoperative Serum Isthmin Levels, Postoperative Third Month's Serum Isthmin Levels, Preoperative BMI
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Saglik Bilimleri Universitesi
Indolent Systemic Mastocytosis
An Observational Study in Participants With Indolent Systemic Mastocytosis (ISM)
This is a Phase 4, non-interventional, observational study to collect detailed data on the clinical characteristics, clinical outcomes and medical management of ISM in real-world settings.
- Trial name
- NCT07264959
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- Blueprint Medicines Corporation