15 completed, 2 terminated, 2 withdrawn, 1 not yet recruiting. 20 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 15, Terminated 2, Withdrawn 2, Not yet recruiting 1 |
| Phase 2 | 2 | Terminated 2 |
Follow Spasticity: new trials by email Literature Review of Spasticity trials Research Report on Spasticity
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 |
|---|---|---|---|---|---|---|
| A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis Arbaclofen, Placebo - Spasticity | Phase 3 | Not yet recruiting | RVL Pharmaceuticals, Inc. | 442 | 2027-01-01 | 2025-12-03 |
| 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 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 |
| Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy IncobotulinumtoxinA (8 Units per kg body weight), IncobotulinumtoxinA (6 Units per kg body weight), IncobotulinumtoxinA (2 Units per kg body weight) - Cerebral Palsy, Spasticity | Phase 3 | Completed | Merz Pharmaceuticals GmbH | 351 | 2014-03-28 | 2021-08-05 |
| A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity Botulinum toxin type A - Spasticity, Stroke | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 197 | 2013-09-01 | 2016-03-03 |
| Phase III Study of Botulax® to Treat Post Stroke Upper Limb Spasticity Botulinum toxin type A(Botulax®), Botulinum toxin type A(Botox®) - Stroke, Spasticity | Phase 3 | Completed | Hugel | 186 | 2013-06-01 | 2015-05-04 |
| Safety Study of SPARC1104 SPARC1104 modified dose regimen I, SPARC1104 modified dose regimen II, SPARC1104 modified dose regimen III - Spasticity | Phase 3 | Completed | Sun Pharma Advanced Research Company Limited | 375 | 2013-04-09 | 2019-05-03 |
| One Year, Open Label, Dose Escalation Long-term Safety Study in Multiple Sclerosis (MS) Subjects With Spasticity arbaclofen - Multiple Sclerosis, Spasticity | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 150 | 2013-04-01 | 2022-04-25 |
| Efficacy and Safety of SPARC0921 in Subjects With Spasticity SPARC0921, Placebo0921 - Spasticity | Phase 3 | Completed | Sun Pharma Advanced Research Company Limited | 392 | 2012-11-14 | 2019-06-18 |
| Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis arbaclofen, baclofen, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 353 | 2012-11-01 | 2022-04-25 |
| MEDITOXIN® Versus BOTOX® in the Treatment of Post-stroke Spasticity of the Upper Limb Spasticity Botulinum toxin type A, Botulinum Toxin type A - Spasticity | Phase 3 | Completed | Medy-Tox | 196 | 2011-03-01 | 2019-03-29 |
| Continuous Intrathecal Baclofen Infusion for Chronic Spasticity Prometra Programmable Implantable Pump System - Spasticity | Phase 3 | Withdrawn | Flowonix Medical | 2010-01-01 | 2015-03-06 | |
| Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity Botulinum toxin type A from laboratory Lanzhou, Botulinum toxin type A from laboratory Allergan - Spasticity | Phase 3 | Completed | Hospital de Clinicas de Porto Alegre | 56 | 2009-03-01 | 2011-07-07 |
| A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS) Sativex®, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Completed | Jazz Pharmaceuticals | 572 | 2008-01-01 | 2023-05-06 |
| Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Sativex, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Completed | Jazz Pharmaceuticals | 36 | 2007-11-01 | 2023-05-06 |
| A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis. Sativex®, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Completed | Jazz Pharmaceuticals | 189 | 2002-06-01 | 2023-05-06 |
| A Study of the Long-term Safety of Sativex Use GW-1000-02 - Multiple Sclerosis, Spasticity | Phase 3 | Completed | Jazz Pharmaceuticals | 507 | 2002-02-01 | 2023-05-06 |
| Dutch National ITB Study in Children With Cerebral Palsy baclofen, intrathecal, infusion pump for intrathecal baclofen, Synchromed, Medtronic - Cerebral Palsy, Spasticity | Phase 3 | Completed | Maastricht University | 18 | 2002-01-01 | 2007-11-19 |
| A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis GW-1000-02 - Multiple Sclerosis, Spasticity | Phase 3 | Completed | Jazz Pharmaceuticals | 137 | 2001-07-01 | 2023-01-10 |
| Phase 3, 28-week, Randomized, Double-blind, Placebo-controlled Safety and Efficacy Study of Nabiximols as an add-on Therapy in Subjects With Spasticity Due to Multiple Sclerosis. Sativex, Placebo - Spasticity, Multiple Sclerosis | Phase 3 | Withdrawn | GW Research Ltd | 2016-08-11 |
Muscle Spasticity (20) · Multiple Sclerosis (10) · Stroke (5) · Cerebral Palsy (4) · Brain Injuries, Traumatic (2) · Hemiplegia (2) · Brain Injuries (1) · Nervous System Diseases (1) · Neurodegenerative Diseases (1) · Pain (1)
Muscle Hypertonia (20) · Muscular Diseases (20) · Musculoskeletal Diseases (20) · Neurologic Manifestations (20) · Neuromuscular Manifestations (20) · Pathological Conditions, Signs and Symptoms (20) · Signs and Symptoms (20) · Nervous System Diseases (19) · Autoimmune Diseases (10) · Autoimmune Diseases of the Nervous System (10) · Demyelinating Autoimmune Diseases, CNS (10) · Demyelinating Diseases (10) · Immune System Diseases (10) · Brain Diseases (7) · Central Nervous System Diseases (7)
nabiximols (6) · Botulinum Toxins, Type A (4) · arbaclofen placarbil (3) · Baclofen (2) · Clinical Trials, Phase II as Topic (2) · Clinical Trials, Phase III as Topic (2) · rimabotulinumtoxinB (2) · 3-deoxyglycero-galacto-nonulosonic acid (1) · Infusion Pumps (1) · incobotulinumtoxinA (1)
Jazz Pharmaceuticals (5) · RVL Pharmaceuticals, Inc. (3) · Solstice Neurosciences, LLC, a subsidiary of MDD US Operations, LLC (2) · Sun Pharma Advanced Research Company Limited (2) · Daewoong Pharmaceutical Co. LTD. (1) · Flowonix Medical (1) · GW Research Ltd (1) · Hospital de Clinicas de Porto Alegre (1) · Hugel (1) · Maastricht University (1) · Medy-Tox (1) · Merz Pharmaceuticals GmbH (1)
United States (7) · United Kingdom (5) · Russia (4) · Ukraine (4) · Hungary (3) · Poland (3) · South Korea (3) · Argentina (1) · Brazil (1) · Germany (1) · Mexico (1) · Netherlands (1)
Joseph T Hull, PhD (2) · Beom Seon Gwon, Ph.D (1) · Christine Collin, MB BS MRCP FRCP (1) · Johan SH Vles, MD, PhD, Prof (1) · Michael Serpell, ChB FRCA (1) · Min Ho Chun, Ph.D (1) · Min-ho Chun, Ph.D. (1) · Moon Suk Bang, Ph.D (1) · Nam Jong Baik, Ph. D (1) · Nicole Ruas (1) · Paul Davies, MRCP, FRCP (1) · Paulo D Picon (1) · Praveen Tyle, Ph.D. (1)
PMID 25475413, PMID 17086911, PMID 17355549, PMID 21362108, PMID 21878454, PMID 22878432, PMID 23468866, PMID 26030192, PMID 34339951, PMID 36136523