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
Indolent Systemic Mastocytosis
Safety and Efficacy of Subcutaneous Sarilumab in Improving the Quality of Life in People With Indolent Systemic Mastocytosis
Background: Mast cells help the body fight disease and heal wounds. People with indolent systemic mastocytosis (ISM) make too many mast cells. This causes pain, tiredness, digestive problems, and other symptoms.
- Trial name
- NCT03770273
- Testing
- sarilumab
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
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