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Trial record 95 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Brain Injuries, Traumatic

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 (SIPEXI)

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ClinicalTrials.gov Identifier: NCT02270736
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Brief Summary:
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.

Condition or disease Intervention/treatment Phase
Chronic Troublesome Sialorrhea Cerebral Palsy Stroke Traumatic Brain Injury Intellectual Disability Drug: IncobotulinumtoxinA Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Children and Adolescents (2-17 Years) With Chronic Troublesome Sialorrhea Associated With Neurological Disorders, and/or Intellectual Disability
Actual Study Start Date : February 9, 2015
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : May 7, 2019


Arm Intervention/treatment
Experimental: IncobotulinumtoxinA (Xeomin)
  • Main and extension period: subjects to receive on average 2 units incobotulinumtoxinA per kg body weight per treatment cycle (subjects with a body weight ≥ 30 kg to receive a fixed total dose of 75 U per cycle).
  • Mode of administration: Four injections at the beginning of each treatment cycle (parotid and submandibular glands, bilateral)
Drug: IncobotulinumtoxinA
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Placebo Comparator: Placebo
  • For subjects aged 6-17 years only.
  • Main period (1 treatment cycle): Subjects to receive placebo injection.
  • Extension period (3 treatment cycles): Subjects to receive on average 2 Units IncobotulinumtoxinA per kg body weight per treatment cycle (subjects with a body weight ≥ 30 kg to receive a fixed total dose of 75 U per cycle).
  • Mode of administration: Four injections at the beginning of each treatment cycle (parotid and submandibular glands, bilateral)
Drug: IncobotulinumtoxinA
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).




Primary Outcome Measures :
  1. Change in unstimulated salivary flow rate [uSFR] from baseline to Week 4 [ Time Frame: Baseline to week 4 ]
    For subjects aged 6-17 years only. uSFR: weighing of dental rolls soaked with saliva over 5 minutes; procedure repeated after 30 minutes. The reduction of measured weight over the study relates to improvement of sialorrhea.

  2. Global Impression of Change Scale [GICS] at Week 4 representing the functional improvement in drooling since baseline as assessed by the carer/parent(s). [ Time Frame: Week 4 ]
    This is a co-primary outcome measure. For subjects aged 6-17 years only. The GICS is used to measure the carer's/parent's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.

  3. Occurrence of treatment emergent AEs [TEAEs] overall and by injection cycle [ Time Frame: Baseline up to week 64 ]

Secondary Outcome Measures :
  1. Change in uSFR from baseline to Week 8 and 12. [ Time Frame: Baseline up to week 12 ]
    For subjects aged 6-17 years only.

  2. GICS at Week 8 and 12. [ Time Frame: Up to week 12 ]
    For subjects aged 6-17 years only.

  3. Occurrence of treatment emergent AESIs [TEAESIs] overall and by injection cycle [ Time Frame: Baseline up to week 64 ]
  4. Occurrence of treatment emergent SAEs [TESAEs] overall and by injection cycle [ Time Frame: Baseline up to week 64 ]
  5. Occurrence of TEAEs related to treatment as assessed by the investigator overall and by injection cycle [ Time Frame: Baseline up to week 64 ]
  6. Occurrence of TEAEs leading to discontinuation overall and by injection cycle [ Time Frame: Baseline up to week 64 ]


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female child/adolescent age 2-17 years.
  • Any neurological disorder (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability associated with chronic troublesome sialorrhea for at least 3 months up to the screening. In subjects with intellectual disability (ID) without neurological disorders, a diagnosis of ID by a specialist, e.g. pediatrician or by a center for developmental medicine is required for inclusion.
  • Severe drooling (modified Teacher´s Drooling Scale [mTDS] ≥ 6; clothing occasionally becomes damp) as rated by the investigator.
  • Parental consent and the subject's oral or written assent as the subject is able to provide.

Exclusion Criteria:

  • Chronic troublesome sialorrhea not related to neurological disorders and/or intellectual disability.
  • Body weight < 12 kg.
  • Pharmacological treatment for sialorrhea or concomitant medication known to influence sialorrhea strongly (e.g. anticholinergics with exception of locally applied or short acting drugs used under general anesthesia) within 45 days before baseline and during the entire study period.
  • Any previous known or suspected hypersensitivity to Botulinum toxin.
  • Aspiration pneumonia within 6 month before screening.
  • Any previous treatment with Botulinum toxin for any body region during the year before screening or within the screening period
  • Prior, concomitant or planned surgery or irradiation to head and neck to control sialorrhea (including salivary gland surgery or salivary gland irradiation) within one year before screening or planned for any part of the entire study period.
  • Concurrent diseases, including hematological, hepatic, renal, gastrointestinal, endocrine, pulmonary, musculoskeletal, or psychiatric diseases or conditions, which in the judgment of the investigator would put the subject at risk while in the study, could influence the results of the study, or negatively impact the subject's ability to participate in the study.
  • Extremely poor dental and/or oral condition that might preclude safe study participation by the judgment of the investigator.
  • Nursing mother or pregnant female subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270736


Locations
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Georgia
Merz Investigational Site #9950003
Kobuleti, Georgia, 6200
Merz Investigational Site #9950001
Tbilisi, Georgia, 0159
Merz Investigational Site #9950002
Tbilisi, Georgia, 0159
Hungary
Merz Investigational Site #0360017
Balassagyarmat, Hungary, 2660
Merz Investigational Site #0360013
Budapest, Hungary, 1083
Merz Investigational Site # 0360014
Budapest, Hungary, 1125
Merz Investigational Site # 0360015
Budapest, Hungary, 1125
Merz Investigational Site #0360018
Budapest, Hungary, 1146
Merz Investigational Site #0360016
Szombathely, Hungary, 9700
Poland
Merz Investigational Site #0480092
Bialystok, Poland, 15-274
Merz Investigational Site #0480090
Gdansk, Poland, 80-952
Merz Investigational Site #0480076
Katowice, Poland, 40-954
Merz Investigational Site #0480059
Krakow, Poland, 30-359
Merz Investigational Site #0480060
Wiazowna, Poland, 05-462
Russian Federation
Merz Investigational Site #0070016
Kazan, Russian Federation, 420012
Merz Investigational Site # 0070288
Kemerovo, Russian Federation, 650066
Merz Investigational Site #0070290
Khabarovsk, Russian Federation, 680038
Merz Investigational # 0070017
Saint Petersburg, Russian Federation, 194100
Merz Investigational Site #0070013
Smolensk, Russian Federation, 214018
Merz Investigational Site # 070019
Stavropol, Russian Federation, 355029
Merz Investigational Site #0070300
Tomsk, Russian Federation, 634052
Merz Investigational Site #0070301
Yekaterinburg, Russian Federation, 620149
Serbia
Merz Investigational Site #3810001
Belgrade, Serbia, 11040
Ukraine
Merz Investigational Site #3800001
Dnipropetrovsk, Ukraine, 49027
Merz Investigational Site #3800012
Ivano-Frankivsk, Ukraine, 76014
Merz Investigational Site #3800005
Kharkiv, Ukraine, 61068
Merz Investigational Site #3800007
Kharkiv, Ukraine, 61153
Merz Investigational Site #3800013
Kherson, Ukraine, 73010
Merz Investigational site #3800003
Odesa, Ukraine, 65012
Merz Investigational Site #3800009
Ternopil, Ukraine, 46020
Merz Investigational Site #3800011
Zaporizhzhya, Ukraine, 69063
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH

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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02270736     History of Changes
Other Study ID Numbers: MRZ60201_3091_1
2013-004532-30 ( EudraCT Number )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Cerebral Palsy
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic
Sialorrhea
Intellectual Disability
Nervous System Diseases
Central Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins, Type A
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents