Clinical Trials Logo

Clinical Trial Summary

HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.


Clinical Trial Description

- Approximately 84 eligible study participants will be randomized to either CAP-1002 or placebo in a 1:1 ratio.

- The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9, and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.

- Safety evaluations will include adverse events, concomitant medications, physical exam, vital signs, 12-lead ECG, and clinical laboratory testing.

- Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing, cardiac MRI, and quality of life.

- If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an open-label extension study to offer CAP-1002 to study participants who were randomized to placebo and completed all trial visits during the 12-month period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03406780
Study type Interventional
Source Capricor Inc.
Contact
Status Completed
Phase Phase 2
Start date March 4, 2018
Completion date March 10, 2020

See also
  Status Clinical Trial Phase
Completed NCT05086809 - Investigation of an Updated Bone-anchored Sound Processor N/A
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Completed NCT03295786 - Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease Phase 1/Phase 2
Completed NCT01915368 - Determining Optimal Post-Stroke Exercise (DOSE) N/A
Completed NCT01922258 - Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Phase 3
Terminated NCT03270189 - Effect of the Visual Information Change in Functional Dystonia N/A
Active, not recruiting NCT03911388 - HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors Phase 1
Completed NCT02798406 - Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects Phase 2
Suspended NCT04912115 - Randomized, Double-Blind, Active Placebo-Controlled Study of Ketamine to Treat Levodopa-Induced Dyskinesia Phase 2
Completed NCT03994822 - pRESET for Occlusive Stroke Treatment N/A
Completed NCT03336645 - Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan Phase 3
Completed NCT04283253 - Predictors of Response in Chronic Stroke N/A
Not yet recruiting NCT06048523 - Prospective Cohort Study of Neurogenetic Diseases N/A
Completed NCT02684825 - Detection of Silent Atrial Fibrillation aFter Ischemic StrOke N/A
Active, not recruiting NCT02284126 - Topical Vancomycin for Neurosurgery Wound Prophylaxis Phase 3
Completed NCT05815836 - Precision Medicine in Stroke
Completed NCT00739518 - Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams N/A
Recruiting NCT03678194 - Treating Depression on a Day-to-day Basis: Development of a Tool for Physicians Based on a Smartphone Application N/A
Recruiting NCT04698421 - Collection of Biological Samples From Patients With Rare Neurological Diseases