Clinical trials: ISM
Acute Schizophrenia
Study to Evaluate the Efficacy and Safety of Risperidone in Situ Microparticle (ISM)® in Patients With Acute Schizophrenia
This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of intramuscular (IM) injections of Risperidone ISM® (75 or 100 mg) or placebo, in patients with acute…
- Trial name
- PRISMA-3 (NCT03160521)
- Testing
- Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Where
- 31 sites in United States, Ukraine
- Volunteers
- 438 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
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.
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
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
Indolent Systemic Mastocytosis
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002
This is a Phase 1 study to investigate the safety and tolerability of AK002 in patients with indolent systemic mastocytosis (ISM).
- Trial name
- NCT02808793
- Testing
- AK002
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Allakos Inc.
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
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
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
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
Mastocytosis
Mast Cell Connect: A Registry for Patients With Mastocytosis
The Mast Cell Connect Registry is a voluntary, observational database that will capture demographic, socioeconomic, and disease information directly from patients with mastocytosis via a secure web-based tool.
- Trial name
- NCT02620254
- Where
- United States
- Volunteers
- 743 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
Mastocytosis, Systemic Mastocytosis
Treatment of Indolent Systemic Mastocytosis With PA101
This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in adult patients with indolent systemic mastocytosis (ISM).
- Conditions
- Mastocytosis, Systemic Mastocytosis, Indolent Systemic Mastocytosis
- Trial name
- NCT02478957
- Testing
- PA101
- Where
- 8 sites in France, Germany and 3 more
- Volunteers
- 41 people
- Sponsor
- Patara Pharma
Schizophrenia, Schizoaffective Disorder
Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.
- Trial name
- PRISMA-1 (NCT01788774)
- Testing
- Risperidone ISM 50 mg, Risperidone ISM 75 mg, Risperidone ISM 100 mg
- Where
- 5 sites in Croatia, Russia and 2 more
- Volunteers
- 36 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
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
Myelofibrosis, Indolent Systemic Mastocytosis
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5).
- Trial name
- NCT04655118
- Testing
- TL-895
- Where
- 52 sites in United States, Australia and 11 more
- Volunteers
- 121 people
- Sponsor
- Telios Pharma, Inc.
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
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
Aggressive Systemic Mastocytosis (ASM), SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD)
Patient-Reported Outcome Questionnaire for Systemic Mastocytosis
The purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition.
- Conditions
- Aggressive Systemic Mastocytosis (ASM), SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD), Mast Cell Leukemia (MCL), Smoldering Systemic Mastocytosis (SSM)
- Trial name
- NCT02380222
- Testing
- Interview
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Adelphi Values LLC
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
Schizophrenia
Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and…
- Trial name
- PRISMA-2 (NCT02086786)
- Testing
- Risperidone ISM
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Rovi Pharmaceuticals Laboratories