The effect of using Cannabidiol on the severity of spasticity in MS patients with gait disorders

Effects of oral cannabidiol (CBD) usage on variable severity of spasticity in multiple sclerosis patients with gait problem caused by their spasticity. A Double-Blind Randomised Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220815055709N1

Enrollment

Registered

2022-12-17

Start date

2023-01-21

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Spasticity in multiple sclerosis patients with gait problem. Multiple sclerosis

Interventions

Intervention 1: Intervention group: MS patients are diagnosed with spasticity and the resulting gait disorder. These patients are randomly assigned to the intervention group according to the described

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of MS based on McDonald's 2017 criteria by a neurologist Expanded Disability Status Scale lower than (EDSS<7) Patients with gait disorder Age above 18 years

Exclusion criteria

Exclusion criteria: History of any liver dysfunction Known sensitivity to any component of the drug Taking drugs with liver metabolism such as Warfarin, Clobazam, and Sodium valproate Pregnancy or breastfeeding Use of marijuana or cannabis-derived compounds in the last 6 months

Design outcomes

Primary

Measure	Time frame
The severity of spasticity in Multiple sclerosis patients with gait problem following the use of Cannabidiol. Timepoint: The severity of the patient's spasticity before starting the drug and after 3 and 6 weeks from the start. Method of measurement: Severity of spasticity will be measured based on Numeric rating scale (0-10).	—

Secondary

Measure	Time frame
Quality of patient's life. Timepoint: The patient's quality of life will be measured before and after 8 weeks of the intervention. Method of measurement: Patient quality of life will be measured using The European Quality of Life scale.;The severity of the patient's gait problem. Timepoint: The severity of the patient's gait disorder will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: The severity of the patient's gait problem using a SF12 short questionnaire with 12 questions.;Sleep quality. Timepoint: Sleep quality will also be measured at the beginning and after 6 weeks from the beginning of the study. Method of measurement: Sleep quality will be measured using a SF12 short questionnaire with 12 questions.;The severity of pain. Timepoint: The severity of pain of the patients will also be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: Pain of the patients using a SF12 short questionnaire with 12 questions.;Patients' Urinary disorders. Timepoint: Urinary disorders of the patients will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: urinary disorders of the patients will be measured using a SF12 short questionnaire with 12 questions.	—

Measure

Time frame

Quality of patient's life. Timepoint: The patient's quality of life will be measured before and after 8 weeks of the intervention. Method of measurement: Patient quality of life will be measured using The European Quality of Life scale.;The severity of the patient's gait problem. Timepoint: The severity of the patient's gait disorder will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: The severity of the patient's gait problem using a SF12 short questionnaire with 12 questions.;Sleep quality. Timepoint: Sleep quality will also be measured at the beginning and after 6 weeks from the beginning of the study. Method of measurement: Sleep quality will be measured using a SF12 short questionnaire with 12 questions.;The severity of pain. Timepoint: The severity of pain of the patients will also be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: Pain of the patients using a SF12 short questionnaire with 12 questions.;Patients' Urinary disorders. Timepoint: Urinary disorders of the patients will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: urinary disorders of the patients will be measured using a SF12 short questionnaire with 12 questions.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactPegah Mousavi

Ghaem Hospital Mashhad

Pegahmsv@gmail.com+98 21 3840 0001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026