19 completed, 5 active not recruiting, 1 terminated. 15 Phase 3, 7 Phase 2, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 10, Active not recruiting 5 |
| Phase 2 | 7 | Completed 6, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow NT 201: new trials by email Literature Review of NT 201 trials Research Report on NT 201
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 of NT 201 in Adults With Moderate to Severe Platysma Prominence in Europe (PLATINUM EU) NT 201, NT 201 Placebo - Neuromuscular Agents, Peripheral Nervous System Agents | Phase 3 | Active not recruiting | Merz Aesthetics GmbH | 300 | 2025-10-01 | 2026-09-10 |
| A Study of NT 201 in Adults With Moderate to Severe Platysma Prominence in the United States NT 201, NT 201 Placebo - Neuromuscular Agents, Peripheral Nervous System Agents | Phase 3 | Active not recruiting | Merz North America, Inc. | 300 | 2025-08-27 | 2026-09-10 |
| A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine Xeomin, Placebo - Chronic Migraine | Phase 3 | Active not recruiting | Merz Therapeutics GmbH | 808 | 2025-08-21 | 2026-10-14 |
| A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine Xeomin, Placebo - Episodic Migraine | Phase 3 | Active not recruiting | Merz Therapeutics GmbH | 997 | 2025-08-21 | 2026-10-14 |
| A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury IncobotulinumtoxinA, Placebo - Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve Injury | Phase 2 | Completed | Merz Therapeutics GmbH | 123 | 2023-11-22 | 2026-05-05 |
| Assessment of Long-term Clinical Response to BoNT in Cervical Dystonia CC BoNT/A, CF BoNT/A, CF to CC BoNT/A - Cervical Dystonia | Completed | Merz Therapeutics GmbH | 270 | 2023-07-08 | 2024-08-21 | |
| A Study of NT 201 Doses in the Treatment of Platysma Prominence NT 201, NT 201 Placebo - Platysma Prominence | Phase 2 | Completed | Merz Aesthetics GmbH | 73 | 2023-03-22 | 2024-10-21 |
| A Study of NT 201 in the Treatment of Enlarged Pores and Excessive Sebum Production in the Face NT 201, Placebo - Enlarged Pores, Sebum Production | Phase 1 | Completed | Merz North America, Inc. | 31 | 2022-10-27 | 2024-08-23 |
| A Study to Investigate the Efficacy and Safety of NT 201 (Botulinum Toxin) Compared With Placebo for the Treatment of Adult Participants With Essential Tremor in the Arm NT 201, Placebo - Essential Tremor of the Upper Limb | Phase 2 | Completed | Merz Pharmaceuticals GmbH | 78 | 2021-02-24 | 2026-05-28 |
| Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines NT 201, Placebo - Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines) | Phase 3 | Completed | Merz North America, Inc. | 368 | 2020-11-12 | 2024-08-06 |
| Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Lateral Canthal Lines) in Subjects With Moderate to Severe Upper Facial Lines NT 201, Placebo - Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines) | Phase 3 | Completed | Merz North America, Inc. | 362 | 2020-09-23 | 2024-05-08 |
| Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury NT 201, Placebo - Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury | Phase 3 | Active not recruiting | Merz Pharmaceuticals GmbH | 603 | 2019-09-16 | 2026-10-20 |
| Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines NT 201 - Moderate to Severe Glabellar Frown Lines | Phase 2 | Completed | Merz Aesthetics GmbH | 241 | 2019-01-23 | 2023-11-15 |
| Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability NT 201 Placebo, NT 201 - Chronic Troublesome Sialorrhea, Cerebral Palsy | Phase 3 | Completed | Merz Pharmaceuticals GmbH | 256 | 2015-02-09 | 2021-08-10 |
| Botulinum Toxin A to Treat Arm Tremor IncobotulinumtoxinA, Placebo - Essential Tremor of the Upper Limbs | Phase 2 | Completed | Merz Pharmaceuticals GmbH | 30 | 2014-12-05 | 2021-02-18 |
| Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy Xeomin, Botox® - Cerebral Palsy, Spastic Paraplegia and Hemiparesis | Phase 2 | Completed | Merz Pharmaceuticals GmbH | 64 | 2014-07-01 | 2017-01-26 |
| Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units), Placebo - Chronic Troublesome Sialorrhea, Parkinson's Disease | Phase 3 | Completed | Merz Pharmaceuticals GmbH | 184 | 2014-04-01 | 2018-03-27 |
| 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 |
| Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid IncobulinumtoxinA (Xeomin), 25 Units, IncobotulinumtoxinA (Xeomin), 12.5 Units, Placebo - Bilateral Blepharospasm (BEB) | Phase 3 | Completed | Merz Pharmaceuticals GmbH | 61 | 2013-11-01 | 2018-03-01 |
| Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy IncobotulinumtoxinA (16-20 Units per kg body weight) - Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy | Phase 3 | Completed | Merz Pharmaceuticals GmbH | 370 | 2013-08-01 | 2017-10-27 |
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Brain Injuries, Traumatic (3) · Cerebral Palsy (3) · Torticollis (2) · Blepharospasm (1) · Dystonic Disorders (1) · Intellectual Disability (1) · Muscle Spasticity (1) · Neuralgia, Postherpetic (1) · Paraplegia (1) · Paresis (1) · Parkinson Disease (1) · Peripheral Nerve Injuries (1) · Stroke (1)
Merz Pharmaceuticals GmbH (14) · Merz North America, Inc. (4) · Merz Therapeutics GmbH (4) · Merz Aesthetics GmbH (3)
Germany (15) · Poland (11) · United States (11) · France (7) · Spain (7) · Russia (6) · Austria (5) · Canada (5) · Czechia (5) · Slovakia (5) · Ukraine (5) · Italy (4) · Switzerland (4) · United Kingdom (4) · Hungary (3)
Bettina Wabbels, MD (1) · Matthias Imhof, MD (1) · Michael P Barnes, MD, FRCP (1) · Prof. Dirk Dressler, MD (1)
PMID 36136523, PMID 39475143, PMID 40968493, PMID 22010053, PMID 23687362, PMID 30918101, PMID 31794936, PMID 32779096, PMID 33211907, PMID 33419261, PMID 34092664, PMID 34339951, PMID 34341153, PMID 34384301, PMID 34957963
2018 (2), 2008 (1), 2019 (1)