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

NCT02212119 | Completed Phase 2 DMC

• 1 other identifier: NT-036
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Dementia; Paratonia

Keywords

Dementia; Paratonia; Caregiver Burden; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• Impact on care-giver burden

  Impact on caregiver burden in providing upper extremity care. Measured by the Carer Burden Scale which includes four items (cleaning the palm, cutting the fingernails, dressing, cleaning under the armpit). Each item rated on five point Likert scale ("no difficulty" to "cannot do task").

  6 weeks for primary outcome, 32 weeks for entire study

Secondary Outcomes (4)

• Visual Analogue Scale

  6 weeks for secondary outcome, 32 weeks for entire study

• Joint angle measurement

  6 weeks for secondary outcome, 32 weeks for entire study

• Pain

  6 weeks for secondary outcome, 32 weeks for entire study

• Global Assessment

  6 weeks for secondary outcome, 32 weeks for entire study

Study Arms (2)

Saline

PLACEBO COMPARATOR

Saline injection up to 5 cc in arm with paratonia (one time injection)

Drug: Saline

Botulinum Toxin

ACTIVE COMPARATOR

Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)

Drug: Botulinum Toxin

Interventions

Botulinum Toxin DRUG

Also known as: Xeomin

Botulinum Toxin

Saline DRUG

Saline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe cognitive impairment (complete dependency in all activities of daily living (ADLs)
• 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

You may not qualify if:

• Alternate etiologies for increased tone
• Botulinum toxin 6 months preceding the study

Sponsors & Collaborators

• Assistive Technology Clinic, Canada: lead
• Merz Pharmaceuticals GmbH: collaborator
• Baycrest: collaborator

Study Sites (1)

Assistive Technology Clinic at Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (26)

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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.

  PMID: 25536218 DERIVED

MeSH Terms

Conditions

Dementia; Muscle Rigidity; Caregiver Burden

Interventions

Botulinum Toxins; incobotulinumtoxinA; Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Galit Kleiner-Fisman, MD

  University of Toronto, Baycrest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: December 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

CA (1)