Trial | NCT02212119  Report issue

Title

Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Paratonia ...

  • Study Participants

    10
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.
Study Started
Dec 31
2010
Primary Completion
Feb 28
2013
Study Completion
Jan 31
2014
Last Update
Aug 08
2014
Estimate

Drug Botulinum Toxin

  • Other names: Xeomin

Drug Saline

Saline Placebo Comparator

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

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)

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

Alternate etiologies for increased tone
Botulinum toxin 6 months preceding the study
No Results Posted