Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
NCT ID: NCT02212119
Last Updated: 2014-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2010-12-31
2014-01-31
Brief Summary
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The primary objective is to confirm proof of principle that paratonic rigidity and the consequences associated with it can be reduced with injection of Botulinum toxin injections resulting in reduced care-giver burden.
The secondary objectives are to determine optimal time points for evaluation of efficacy in this patient population and whether the time period is sufficient for washout of Botulinum toxin effect; determine most salient and sensitive outcome measures; identify obstacles in data gathering; and lastly, to determine feasibility of battery of assessments in this pilot study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Saline
Saline injection up to 5 cc in arm with paratonia (one time injection)
Saline
Botulinum Toxin
Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)
Botulinum Toxin
Interventions
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Botulinum Toxin
Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia
* Score\> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care
Exclusion Criteria
* Botulinum toxin 6 months preceding the study
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Baycrest
OTHER
Assistive Technology Clinic, Canada
OTHER
Responsible Party
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Dr. Galit Kleiner-Fisman
Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto
Principal Investigators
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Galit Kleiner-Fisman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto, Baycrest
Locations
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Assistive Technology Clinic at Baycrest
Toronto, Ontario, Canada
Countries
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References
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Fox PJ, Kohatsu N, Max W, Arnsberger P. Estimating the costs of caring for people with Alzheimer disease in California: 2000-2040. J Public Health Policy. 2001;22(1):88-97.
Hobbelen JS, Koopmans RT, Verhey FR, Habraken KM, de Bie RA. Diagnosing paratonia in the demented elderly: reliability and validity of the Paratonia Assessment Instrument (PAI). Int Psychogeriatr. 2008 Aug;20(4):840-52. doi: 10.1017/S1041610207006424. Epub 2008 Jan 7.
Franssen EH, Kluger A, Torossian CL, Reisberg B. The neurologic syndrome of severe Alzheimer's disease. Relationship to functional decline. Arch Neurol. 1993 Oct;50(10):1029-39. doi: 10.1001/archneur.1993.00540100024010.
Hobbelen JS, Verhey FR, Bor JH, de Bie RA, Koopmans RT. Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940). BMC Geriatr. 2007 Dec 19;7:30. doi: 10.1186/1471-2318-7-30.
Souren LE, Franssen EH, Reisberg B. Neuromotor changes in Alzheimer's disease: implications for patient care. J Geriatr Psychiatry Neurol. 1997 Jul;10(3):93-8. doi: 10.1177/089198879701000301.
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Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400. doi: 10.1056/NEJMoa011892.
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Naumann M, Yakovleff A, Durif F; BOTOX Cervical Dystonia Prospective Study Group. A randomized, double-masked, crossover comparison of the efficacy and safety of botulinum toxin type A produced from the original bulk toxin source and current bulk toxin source for the treatment of cervical dystonia. J Neurol. 2002 Jan;249(1):57-63. doi: 10.1007/pl00007848.
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Kleiner-Fisman G, Khoo E, Moncrieffe N, Forbell T, Gryfe P, Fisman D. A randomized, placebo controlled pilot trial of botulinum toxin for paratonic rigidity in people with advanced cognitive impairment. PLoS One. 2014 Dec 23;9(12):e114733. doi: 10.1371/journal.pone.0114733. eCollection 2014.
Other Identifiers
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NT-036
Identifier Type: -
Identifier Source: org_study_id
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