N/A N=18 Botulinum Toxin as a Novel Treatment for Prevention of Post-Traumatic Elbow Stiffness
Post Traumatic Stiffness
Primary: Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire — 27; 54 Scores on a Scale (0-100) — p=0.06
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 2 N=32 Botulinum Toxin Type A in Preventing Complications After Surgery in Patients With Esophageal Cancer
Esophageal Carcinoma
Primary: Delayed Gastric Emptying Assessed Radiographically by Nuclear Medicine Emptying Study — 12; 14; 1; 3 Participants — p=0.773
Phase 2 N=30 Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair
Cleft Lip · Scarring · Cleft Palate
Primary: Hypertrophic Scarring (HTS) as Assessed by Score on the Manchester Scar Scale (MSS) Rated by Blinded Plastic Surgeons — 7; 9 score on a scale
N/A N=17 Botulinum Toxin Effects on Plantar Ulcer Recurrence
Diabetes Mellitus · Peripheral Neuropathy · Plantar Ulcers
Primary: Plantar Flexor Muscle Strength — -8; 3; 6 Plantar Flexor Torque (Nm)
Phase 2 N=134 Botulinum Toxin Injection for the Management of BPH
Benign Prostatic Hyperplasia
Primary: Improvement in the AUA Symptom Score Index by 30% From Baseline Within the First 12 Weeks After Injection. — 46; 50 participants — p=<0.05
Phase 2 N=45 Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Botulism
Primary: Four-Fold Increase in Neutralizing Antibody Concentration (NAC) — 0.75; 0.84; 0.75; 0.89 proportion of participants
Phase 3 N=388 A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
Overactive Bladder
Primary: Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes — 4.4; 4.5; -3.4; -3.2 Incontinence Episodes
Phase 3 N=70 Botulinum Toxin for Erectile Dysfunction
Sexual Dysfunction · Erectile Dysfunction
Primary: Right (PSV R) and Left (PSV L) Cavernosal Artery Mean PSV Before Treatment — 34.52; 30.85; 34.33; 31.73 cm/sec
Phase 4 N=65 Comparison of Two Botulinum Type A Products in the Treatment of Blepharospasm
Blepharospasm
Primary: Change From Baseline to Week 4 in Blepharospasm Disability Index — -2.8; -1.3 Points on Scale
Phase 3 N=148 IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb
Post-stroke Upper Limb Spasticity
Primary: Number of Participants With Reduction of at Least 1 Point at Week 4 Compared to Baseline in Ashworth Score in Wrist Flexors — 50; 28 Participants — p=<0.001
N/A N=61 Short Term Follow-up of a Botulinum Toxin Intervention in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Primary: Change in Normalized Muscle Volume of the Medial Gastrocnemius and the Distal Compartment of the Semitendinosus — -0.08; 0.00; -0.09; -0.01 ml/kg*m
Phase 2 N=62 Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
Overactive Bladder
Primary: Mean Change of the Total Frequency Per 3 Days — -4.64; -0.19 Frequency per 3 days
Phase 2 N=21 Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Dystonia
Primary: Physician Global Perception of Change - Blinded Rater 1 — 1; 1; 1; 4 Participants
Phase 3 N=311 Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
Lower Limb Spasticity Due to Cerebral Palsy
Primary: Change From Baseline in the Ashworth Scale (AS) Score of Plantar Flexors of the Primary Body Side at Day 29 (Week 4) of the First Injection Cycle (1st IC) — -0.7; -0.66…
Phase 3 N=370 BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy
Primary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 65.4 percentage of participants
Phase 3 N=370 Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy
Primary: Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle — 53; 44; 26; 31 participants
Phase 3 N=351 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
Cerebral Palsy · Spasticity
Primary: MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 — -0.93; -1.15; -0.96; -1.02 Unit on a scale — p== 0.017
Phase 3 N=381 NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
Glabellar Frown Lines
Primary: Responder by Independent Rater's Assessment at Maximum Frown at Week 4 — 267; 89 participants
Phase 3 N=416 Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Overactive Bladder
Primary: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence — 31.1; 32.3; 28.3; -22.7 Number of Weekly Episodes
Phase 3 N=155 Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm
Spasticity of the Upper and Lower Limb Due to Cerebral Causes
Primary: Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the…
Phase 3 N=185 Efficacy and Safety of Clostridium Botulinum Toxin Type A to Improve Appearance of Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
Primary: The Proportion of Responders at Day 29 in the ILA of Glabellar Lines at Maximum Frown. — 88.3; 1.4 Adjusted percentage of responders — p=<0.0001
Phase 2 N=30 Botulinum Toxin A to Treat Arm Tremor
Essential Tremor of the Upper Limbs
Primary: Change From Baseline to Week 4 in Maximum Angular Tremor Amplitude of the Wrist (Injected Limb) — -0.47; 0.07 degree — p=0.144
Phase 2 N=9 Botulin-A Toxin Instillations and Overactive Bladder
Overactive Bladder · Detrusor Instability · Detrusor Hyperreflexia
Primary: Median Number of Incontinent Episodes During 24 Hours — 4; 2; 4 number of incontinent episodes — p=0.004
N/A N=30 Subcutaneous Botulinum Toxin for Cutaneous Allodynia
Pain
Primary: Time Until Analgesic Failure — 76.3; 79 Days
Phase 3 N=220 BOTOX® Open-Label Treatment in Pediatric Upper Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy
Primary: Percentage of Participants With at Least One Treatment- Emergent Adverse Event (TEAE) — 58.7 percentage of participants
Phase 3 N=355 Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study III (BLESSIII)
Glabellar Frown Lines
Primary: Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the…
Phase 3 N=213 Botulinum Toxin Treatment of Glabellar Lines: Efficacy and Safety Study II
Glabellar Frown Lines
Primary: Facial Wrinkle Scale (FWS) Score of 0 or 1 and an Improvement of ≥ 2 Points in FWS Score (at Maximum Frown) at Week 4 Visit Relative to Baseline, Based on Both the…
Phase 4 N=27 Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Interstitial Cystitis
Primary: The Primary Outcome Will be Assessing the Measurement of Subjective Patient Pain Using the O'Leary-Sant Symptom and Problem Indexes. — 10.92; 10.85; 9.75; 9.92 units on…
Phase 3 N=384 BOTOX® Treatment in Pediatric Lower Limb Spasticity
Pediatrics · Muscle Spasticity · Cerebral Palsy
Primary: Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Ankle Score With Knee Extended at Weeks 4 and 6 — -1.06; -1.01; -0.80 score on a scale — p=0.010
N/A N=55 Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
Urinary Incontinence
Primary: Change From Baseline in Anticholinergic Drug Use — 305.21; 199.77 Doses of Anticholinergic Drugs