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Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness

NCT02212119 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-08-08

No results posted yet for this study

Summary

Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on muscle tone, and caregiver burden in individuals who are cognitively impaired and who are fully dependent.

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.

Conditions

Interventions

DRUG

Botulinum Toxin

DRUG

Saline

Sponsors & Collaborators

  • Merz Pharmaceuticals GmbH

    collaborator INDUSTRY

  • Baycrest

    collaborator OTHER

  • Assistive Technology Clinic, Canada

    lead OTHER

Principal Investigators

  • Galit Kleiner-Fisman, MD · University of Toronto, Baycrest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-02-28
Completion
2014-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02212119 on ClinicalTrials.gov