A trial of rivastigmine to prevent falls in Parkinson's

Phase 3

Completed

• Conditions: Parkinson's Disease; Nervous System Diseases

• Registration Number: ISRCTN41639809
• Lead Sponsor: niversity of Bristol

Brief Summary

2021 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8556953/ (added 15/02/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-16
• Study Completion: 2024-07-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Current participant inclusion criteria as of 05/07/2019:
1. Diagnosis of idiopathic Parkinson’s disease
2. Modified Hoehn and Yahr stage 1-4 disease
3. Have experienced a fall in the previous year
4. Able to walk =10m without aids or assistance
5. 18 years of age or above

Previous participant inclusion criteria:
1. Diagnosis of idiopathic Parkinson’s disease
2. Modified Hoehn and Yahr stage 1-4 disease
3. Have experienced a fall in the previous year
4. Able to walk =10m without aids or assistance

Exclusion Criteria

Current participant exclusion criteria as of 05/07/2019:
1. Previous ChEi use in 12 months prior to enrolment.
2. Hypersensitivity to rivastigmine
3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria
4. Inability to attend or comply with treatment or follow-up scheduling
5. Non-English-speaking patients (cognitive tests performed in English)
6. Falling = 4x per day
7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential
8. Pregnant of breast feeding

Previous participant exclusion criteria:
1. Previous ChEi use in 12 months prior to enrolment
2. Hypersensitivity to rivastigmine
3. Dementia diagnosed according to Movement Disorder Society (MDS) criteria
4. Inability to attend or comply with treatment or follow-up scheduling
5. Non-English-speaking patients (cognitive tests performed in English)
6. Falling = 4x per day
7. Unwillingness to use an acceptable method of contraception for the duration of the trial if they are of childbearing potential

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fall rate measured using monthly diaries and telephone calls prospectively over 12 months from the day the IMP is commenced. A fall is defined as unintentionally coming to rest on the ground or other lower surface without overwhelming external force or a major internal event”