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 (SIAXI)
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| ClinicalTrials.gov Identifier: NCT02091739 |
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Recruitment Status :
Completed
First Posted : March 19, 2014
Results First Posted : February 15, 2018
Last Update Posted : March 27, 2018
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Sponsor:
Merz Pharmaceuticals GmbH
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
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Brief Summary:
The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Troublesome Sialorrhea Parkinson's Disease Post-stroke Traumatic Brain Injury | Drug: IncobotulinumtoxinA (100 Units) Drug: IncobotulinumtoxinA (75 Units) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 184 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 Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions |
| Study Start Date : | April 2014 |
| Actual Primary Completion Date : | August 2015 |
| Actual Study Completion Date : | November 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Parkinson disease
| Arm | Intervention/treatment |
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Experimental: IncobotulinumtoxinA (Xeomin) (100 Units)
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Drug: IncobotulinumtoxinA (100 Units)
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:
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Experimental: IncobotulinumtoxinA (Xeomin) (75 Units)
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Drug: IncobotulinumtoxinA (75 Units)
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:
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Placebo Comparator: Placebo
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Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). |
Primary Outcome Measures :
- MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 [ Time Frame: Baseline and Week 4 ]uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
- MP: Participant's Global Impression of Change Scale (GICS) at Week 4 [ Time Frame: Week 4 ]The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
Secondary Outcome Measures :
- MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 [ Time Frame: Baseline, Week 8 and 12 ]uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
- MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 [ Time Frame: Week 1, 2, 8, and 12 ]The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening).
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Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice):
- A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and
- A score of at least 2 points for each item of the DSFS and
- A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A).
- A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline.
Exclusion Criteria:
- Non-neurological secondary causes of sialorrhea.
- Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study.
- Recent (i.e., four weeks) drug treatment for sialorrhea.
- History of recurrent aspiration pneumonia.
- Extremely poor dental/oral condition as assessed by a qualified dentist.
- Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation.
- Recent (i.e., four weeks) changes in anti-parkinsonian medication.
- Previous or planned surgery or irradiation to control sialorrhea.
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): NCT02091739
Locations
| Germany | |
| Merz investigational site #049172 | |
| Bonn, Germany, 53105 | |
| Merz Investigational Site #049335 | |
| Gera, Germany, 07551 | |
| Merz Investigational Site #049337 | |
| Haag i.OB, Germany, 83527 | |
| Merz Investigational Site #049072 | |
| Munich, Germany, 80804 | |
| Merz Investigational Site #049148 | |
| Munich, Germany, 81675 | |
| Merz Investigational Site #049300 | |
| Nümbrecht, Germany, 51588 | |
| Merz Investigational Site #049303 | |
| Regensburg, Germany, 93053 | |
| Merz investigational site #049348 | |
| Stadtroda, Germany, 07646 | |
| Merz Investigational Site #049143 | |
| Ulm, Germany, 89081 | |
| Merz Investigational Site #049333 | |
| Wolfach, Germany, 77709 | |
| Merz Investigational Site #049302 | |
| Wuerzburg, Germany, 97080 | |
| Poland | |
| Merz investigational site #048068 | |
| Bydgoszcz, Poland, 85-015 | |
| Merz Investigational Site #048088 | |
| Bydgoszcz, Poland, 85-080 | |
| Merz Investigational Site #048029 | |
| Gdansk, Poland, 80-254 | |
| Merz investigational site #048074 | |
| Gdansk, Poland, 80-546 | |
| Merz investigational site #048078 | |
| Jaworzno, Poland, 43-600 | |
| Merz investigational site #048076 | |
| Katowice, Poland, 40-097 | |
| Merz investigational site #048077 | |
| Katowice, Poland, 40-097 | |
| Merz investigational Site #048067 | |
| Kielce, Poland, 25-103 | |
| Merz investigational site #048059 | |
| Krakow, Poland, 30-539 | |
| Merz investigational site #048031 | |
| Krakow, Poland, 31-505 | |
| Merz Investigational Site #048087 | |
| Krakow, Poland, 31-530 | |
| Merz Investigational Site #048022 | |
| Lodz, Poland, 90-130 | |
| Merz investigational site #048070 | |
| Lublin, Poland, 20-718 | |
| Merz investigational site #048085 | |
| Lublin, Poland, 30-539 | |
| Merz investigational site #048072 | |
| Lubon, Poland, 62-030 | |
| Merz Investigational Site #048075 | |
| Sandomierz, Poland, 27-600 | |
| Merz Investigational Site #048086 | |
| Torun, Poland, 87-100 | |
| Merz investigational site #048065 | |
| Warszawa, Poland, 00-453 | |
| Merz investigational site #048056 | |
| Warszawa, Poland, 02-097 | |
| Merz investigational site #048064 | |
| Warszawa, Poland, 03-242 | |
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
| Study Director: | Merz Medical Expert | Merz Pharmaceuticals GmbH |
| Responsible Party: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT02091739 History of Changes |
| Other Study ID Numbers: |
MRZ60201_3090_1 2012-005539-10 ( EudraCT Number ) |
| First Posted: | March 19, 2014 Key Record Dates |
| Results First Posted: | February 15, 2018 |
| Last Update Posted: | March 27, 2018 |
| Last Verified: | January 2018 |
Additional relevant MeSH terms:
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Parkinson Disease Brain Injuries Brain Injuries, Traumatic Sialorrhea Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Salivary Gland Diseases |
Mouth Diseases Stomatognathic Diseases Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA abobotulinumtoxinA 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 |