47 completed. 47 Phase 3, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 47 | Completed 47 |
| Phase 2 | 3 | Completed 3 |
Follow Muscle Hypertonia: new trials by email Literature Review of Muscle Hypertonia trials Research Report on Muscle Hypertonia
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 |
|---|---|---|---|---|---|---|
| Therapeutic Photobiomodulation and Tretament of Spasticity Photobiomodulation, Institution's Standard Physiotherapy, Photobiomodulation Placebo - Muscle Spasticity, Cerebral Palsy | Phase 2 / Phase 3 | Completed | University of Nove de Julho | 12 | 2023-08-15 | 2026-05-01 |
| Trial to Evaluate the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis Nabiximols, Placebo - Spasticity in Participants With Multiple Sclerosis | Phase 3 | Completed | Jazz Pharmaceuticals | 68 | 2020-12-21 | 2023-07-20 |
| Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy Dysport Injectable Product - Cerebral Palsy | Phase 3 | Completed | Columbia University | 12 | 2018-12-12 | 2022-06-01 |
| A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS Arbaclofen - Multiple Sclerosis, Spasticity, Muscle | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 323 | 2018-04-03 | 2022-08-09 |
| A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS Arbaclofen, Placebo - Multiple Sclerosis, Spasticity, Muscle | Phase 3 | Completed | RVL Pharmaceuticals, Inc. | 536 | 2018-01-28 | 2022-07-15 |
| CORETOX® in Treatment of Post Stroke Upper Limb Spasticity (Phase3) CORETOX®, BOTOX® - Muscle Spasticity | Phase 3 | Completed | Medy-Tox | 220 | 2017-11-13 | 2021-12-07 |
| A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity Botulinum toxin A (GSK1358820), Placebo - Spasticity, Post-Stroke | Phase 3 | Completed | GlaxoSmithKline | 124 | 2017-08-02 | 2020-06-02 |
| Comparative Hybrid Effects of Combining BoNT-A With Robot-assisted or Mirror Therapy for U/E Spasticity Stroke Patients Botulinum Toxin Type A, Robot-assisted therapy, Mirror therapy - Stroke | Phase 3 | Completed | Chang Gung Memorial Hospital | 37 | 2016-05-02 | 2018-07-18 |
| Effects of Botulinum Toxin Injections in Patients With Hereditary Spastic Paraplegia Botulinum Toxin Injections, Placebo Injections - Hereditary Spastic Paraplegia | Phase 2 / Phase 3 | Completed | University of Campinas, Brazil | 55 | 2016-03-09 | 2017-11-07 |
| A Study to Evaluate the Botulinum Toxin Type A for Injection(HengLi®) in Subjects With Post-stroke Upper Limb Spasticity Botulinum Toxin Type A for Injection, placebo - Cerebrovascular Accident | Phase 3 | Completed | Lanzhou Institute of Biological Products Co., Ltd | 180 | 2014-07-01 | 2016-09-26 |
| 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 Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years Sativex, Placebo - Cerebral Palsy | Phase 3 | Completed | Jazz Pharmaceuticals | 72 | 2013-12-01 | 2022-12-20 |
| 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 |
| Safety and Efficacy on Spasticity Symptoms of a Cannabis Sativa Extract in Motor Neuron Disease Cannabis Sativa extract Oromucosal spray - Motor Neuron Disease, Amyotrophic Lateral Sclerosis (ALS) | Phase 2 / Phase 3 | Completed | Ospedale San Raffaele | 60 | 2013-01-01 | 2017-03-09 |
| Safety Study of 3 mg/mL Baclofen Injection (Intrathecal) Using A Programmable Pump Gablofen® 3 mg/mL (baclofen injection), SynchroMed® II Programmable Pump - Severe Spasticity | Phase 3 | Completed | Piramal Critical Care, Ltd. | 153 | 2012-12-01 | 2019-05-03 |
| 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 |
| BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity Botulinum Toxin Type A - Pediatrics, Muscle Spasticity | Phase 3 | Completed | Allergan | 370 | 2012-11-05 | 2019-08-21 |
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Muscle Spasticity (47) · Cerebral Palsy (13) · Multiple Sclerosis (13) · Stroke (11) · Spinal Cord Injuries (3) · Amyotrophic Lateral Sclerosis (1) · Hammer Toe Syndrome (1) · Hemiplegia (1) · Marijuana Abuse (1) · Motor Neuron Disease (1) · Pain (1) · Quadriplegia (1) · Spastic Paraplegia, Hereditary (1)
Muscular Diseases (47) · Musculoskeletal Diseases (47) · Nervous System Diseases (47) · Neurologic Manifestations (47) · Neuromuscular Manifestations (47) · Pathological Conditions, Signs and Symptoms (47) · Signs and Symptoms (47) · Central Nervous System Diseases (25) · Brain Diseases (22) · Autoimmune Diseases (13) · Autoimmune Diseases of the Nervous System (13) · Brain Damage, Chronic (13) · Demyelinating Autoimmune Diseases, CNS (13) · Demyelinating Diseases (13)
Botulinum Toxins, Type A (20) · nabiximols (9) · arbaclofen placarbil (4) · Baclofen (3) · Saline Solution (3) · 4-Aminopyridine (2) · Botulinum Toxins (2) · abobotulinumtoxinA (2) · 3-deoxyglycero-galacto-nonulosonic acid (1) · Hengli BTX-A (1) · Infusion Pumps (1) · Injections (1) · Low-Level Light Therapy (1) · Meopa (1) · Mirror Movement Therapy (1)
Jazz Pharmaceuticals (7) · Allergan (5) · GlaxoSmithKline (5) · RVL Pharmaceuticals, Inc. (4) · Acorda Therapeutics (2) · Chang Gung Memorial Hospital (2) · Ipsen (2) · Medy-Tox (2) · Sun Pharma Advanced Research Company Limited (2) · Almirall, S.A. (1) · Assistance Publique - Hôpitaux de Paris (1) · Columbia University (1) · Daewoong Pharmaceutical Co. LTD. (1) · Elan Pharmaceuticals (1) · Hospital de Clinicas de Porto Alegre (1)
United States (19) · Poland (10) · Russia (9) · South Korea (9) · United Kingdom (7) · Canada (6) · Hungary (6) · Turkey (Türkiye) (6) · Ukraine (5) · Italy (4) · Philippines (4) · Thailand (4) · Brazil (3) · Czechia (3) · France (3)
David Jacobs, MD (2) · Emily McCusker (2) · Rozalina Dimitrova (2) · Andrew Blight (1) · Andrew Blight, MD (1) · Ariane Zoll (1) · Beom Seon Gwon, Ph.D (1) · Christine Collin, MB BS MRCP FRCP (1) · Gerard Francisco, MD (1) · Giancarlo Comi, MD (1) · Giancarlo Comi, Prof (1)
PMID 25475413, PMID 10896696, PMID 16777777, PMID 17086911, PMID 17355549, PMID 20358216, PMID 20569068, PMID 21362108, PMID 21878454, PMID 22878432, PMID 23468866, PMID 25592185, PMID 26030192, PMID 28726270, PMID 29330071, PMID 30554828, PMID 32497599, PMID 34339951, PMID 36136523, PMID 36861013, PMID 3809245, PMID 39106541
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