13 completed, 3 terminated, 2 unknown, 1 withdrawn. 9 Phase 2, 6 Phase 3, 4 Phase 4, 3 Phase 1, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 6, Terminated 2, Unknown 1 |
| Phase 3 | 6 | Completed 3, Terminated 2, Withdrawn 1 |
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 3 | Completed 2, Unknown 1 |
| Not applicable | 1 | Completed 1 |
Follow rimabotulinumtoxinB: new trials by email Literature Review of rimabotulinumtoxinB trials Research Report on rimabotulinumtoxinB
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity Phase 2; Low Dose MYOBLOC (10,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 2; Placebo - Spasticity, Cerebrovascular Accident | Phase 2 / Phase 3 | Terminated | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | 32 | 2021-11-02 | 2026-05-27 |
| Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects MYOBLOC Low Dose, MYOBLOC High Dose, Placebo - Sialorrhea | Phase 3 | Withdrawn | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | 2021-11-01 | 2024-09-19 | |
| Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Lower Limb Spasticity Phase 2; Low Dose MYOBLOC (15,000 Units), Phase 2; High Dose MYOBLOC (20,000 Units), Phase 2; Placebo - Spasticity | Phase 2 / Phase 3 | Terminated | Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC | 40 | 2019-12-17 | 2026-05-22 |
| Pilot Study on Botulinum Toxin B as Treatment for Hidradenitis Suppurativa Botulinum B Toxin, Placebo Saline - Hidradenitis Suppurativa | Not applicable | Completed | University Hospital of North Norway | 20 | 2017-06-01 | 2018-10-25 |
| Effect and Safety of Local Injection of Botulinum Toxin Type B Against Digital Ulcer in Systemic Sclerosis Botulinum toxin type B (2500 units / vial), Physiological saline - Systemic Sclerosis Patients With Digital Ulcers | Phase 2 | Completed | Gunma University | 10 | 2016-12-12 | 2020-05-14 |
| New Approaches in Evaluating Patients' Response to Botulinum Toxins in the Treatment of Chronic Neck Pain and Back Pain Botulinum Toxins - Cervicalgia, Low Back Pain | Phase 1 | Unknown | VA Connecticut Healthcare System | 60 | 2016-03-01 | 2017-12-07 |
| Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults MYOBLOC - Sialorrhea | Phase 3 | Completed | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | 187 | 2015-10-01 | 2026-04-21 |
| Myobloc Atrophy Study Botox, MYOBLOC - Spasticity Secondary to Either a Disorder or Trauma, Spinal Cord Injury (SCI) | Phase 4 | Completed | Georgetown University | 10 | 2014-05-01 | 2015-12-16 |
| Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects MYOBLOC, PLACEBO - Sialorrhea | Phase 3 | Completed | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | 187 | 2013-11-01 | 2026-04-21 |
| Botulinum Toxin Treatment in Craniofacial, Inguinal, Palmar, Plantar and Truncal Hyperhidrosis Botox (onabotulinumtoxinA), NeuroBloc/Myobloc (rimabotulinumtoxinB), NaCl (placebo) - Hyperhidrosis | Phase 2 | Unknown | Carl Swartling | 588 | 2013-09-01 | 2018-03-05 |
| Study to Assess the Efficacy of Botulinum Toxin B (Myobloc) for the Treatment of Prosthesis-associated Sweating Botulinum Type B, Placebo - Hyperhidrosis | Phase 1 | Completed | Henry M. Jackson Foundation for the Advancement of Military Medicine | 20 | 2008-09-01 | 2013-01-10 |
| Pilot Study to Assess the Efficacy of Botulinum Toxin B on Pain and Disability in Subjects With Acute Low Back Pain Botulinum toxin B, Placebo - Low Back Pain | Phase 4 | Terminated | United States Department of Defense | 2008-02-01 | 2010-03-02 | |
| A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease Patients Botulinum Toxin Type B (Myobloc), Matched placebo to Myobloc - Drooling | Phase 2 | Completed | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | 54 | 2007-07-01 | 2026-04-21 |
| An Electrophysiological Study Of E2014 In Healthy Adult Male Japanese And Caucasian Subjects E2014 (Botulinum toxin type B), E2014 (Botulinum toxin type B) Placebo - Spasmodic Torticollis | Phase 2 | Completed | Eisai Limited | 48 | 2006-01-01 | 2013-04-25 |
| Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Dose-Response, Study of E2014 in Patients WIth Spasmodic Torticollis BOTULINUM TOXIN TYPE B - Cervical Dystonia, Spasmodic Torticollis | Phase 2 | Completed | Eisai Co., Ltd. | 133 | 2004-06-01 | 2014-03-10 |
| Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) Botulinum toxin type B (Myobloc), Injection of salivary glands - Amyotrophic Lateral Sclerosis, Sialorrhea | Phase 2 / Phase 3 | Completed | The University of Texas Health Science Center at San Antonio | 20 | 2003-07-01 | 2012-03-14 |
| Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia Botulinum toxin, type B - Focal Dystonia | Phase 4 | Completed | Columbia University | 16 | 2003-04-01 | 2014-05-09 |
| "DOES MYOBLOC™ IMPROVE FUNCTIONAL HAND USE IN YOUNG CHILDREN WITH A HYPERTONIC UPPER EXTREMITY?" Botulinum Toxin type B - Cerebral Palsy | Phase 1 / Phase 2 | Completed | Stanford University | 10 | 2002-01-01 | 2005-10-13 |
| Open Label Safety/Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) in Patients With Cervical Dystonia Botulinum Toxin Type B - Cervical Dystonia | Phase 4 | Completed | Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC | 502 | 2001-06-01 | 2026-05-11 |
Sialorrhea (5) · Stroke (5) · Cerebral Palsy (3) · Muscle Spasticity (3) · Torticollis (3) · Amyotrophic Lateral Sclerosis (2) · Brain Injuries, Traumatic (2) · Hemiplegia (2) · Hyperhidrosis (2) · Low Back Pain (2) · Brain Injuries (1) · Dystonic Disorders (1) · Hidradenitis Suppurativa (1) · Motor Neuron Disease (1) · Multiple Sclerosis (1)
Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC (4) · Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC (3) · Carl Swartling (1) · Columbia University (1) · Eisai Co., Ltd. (1) · Eisai Limited (1) · Georgetown University (1) · Gunma University (1) · Henry M. Jackson Foundation for the Advancement of Military Medicine (1) · Stanford University (1) · The University of Texas Health Science Center at San Antonio (1) · United States Department of Defense (1) · University Hospital of North Norway (1) · VA Connecticut Healthcare System (1)
United States (12) · Japan (3) · Hungary (2) · Poland (2) · Ukraine (2) · Belarus (1) · Norway (1) · Russia (1) · Sweden (1)
Jonathan Rubin, MD (2) · Joseph T Hull, PhD (2) · Carl Swartling, MD, PhD (1) · Carlayne E Jackson, MD (1) · Charles B Simpson, MD (1) · Fernando Pagan, MD (1) · Hajime A Tokuno, MD (1) · Hiroki Shimizu (1) · Jack W Tsao, MD (1) · Jonathan Rubin, MD,MBA (1) · Jonathan Rubin, PhD (1) · Jonathan T Rubin, MD (1) · Paul F. Pasquina, M.D. (1) · Sei-ichiro Motegi (1) · Seth Pullman, MD (1)
PMID 14718694, PMID 21887710, PMID 31930364, PMID 32761500, PMID 40498248