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Cannabidiol as a treatment in patients with movement disorder

Cannabidiol as a therapy for spinocerebellar ataxia

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-36x4c4d
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinocerebellar Ataxia

Interventions

This is a single-blind clinical trial, in which participants will be informed and will need to agree and sign that they may receive placebo medication or pure cannabidiol extract, but all will receive

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Universidade Federal do Paraná
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients from the Movement Disorders Outpatient Clinic of the Neurology Service of the Hospital de Clínicas - UFPR (HC - UFPR) over 18 years old who already had the genetic diagnosis of spinocerebellar ataxia type 10 (SCA10); patients who agreed and signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Patients who did not agree with the Informed Consent Form; patients who did not have a genetic diagnosis of SCA10; demented patients; and patients who did not use the intervention correctly.

Design outcomes

Primary

MeasureTime frame
It is expected to find improvement in the clinical evaluation of patients through observation and verification of the decrease in the score of the SARA scale (Scale for the Assessment and Rating of Ataxia) proven by ANOVA statistical analysis of repeated measures comparing the mean score of patients on the SARA scale on study day 0 (before intervention use) and on study day 30 (after one month of intervention use).

Secondary

MeasureTime frame
It is expected to observe the safety and tolerability of the intervention through the observation and report of its adverse effects cited by the patients themselves.

Countries

Brazil

Contacts

Public ContactBárbara Luiza;Ana Chrystina Afonso;Crippa

Universidade Federal do Paraná;Universidade Federal do Paraná

barbara.vianaaf@gmail.com;anaccrippa@gmail.com+55041997246109;+55041988188606

Outcome results

None listed

Source: REBEC (via WHO ICTRP)