Pilot study on the effect of cannabinoids THC + CBD on resistant spasticity in patients with chronic spinal cord injury.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001777-31-ES

Enrollment

Registered

2023-01-31

Start date

2023-05-08

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Pilot study on the effect of THC+CBD cannabinoids on resistant spasticity in patients with chronic spinal cord injury.

Interventions

Trade Name: Sativex 2,7 mg / 2,5 mg Solución para pulverización bucal Product Name: Sativex 2,7 mg / 2,5 mg Solución para pulverización bucal Pharmaceutical Form: Oral spray, suspension INN or Propose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who give informed consent to participate in the study. 2. Patients over 18 years of age. 3. Patients with traumatic or non-traumatic LM, ASIA A, B, C or D, of more than 6 months of evolution. 4. Patients with moderate to severe spasticity, according to the modified Ashworth spasticity scale (= 2) or = 4 on the NRS scale. 5. Patients with insufficient response to the usual combination treatment of baclofen and another anti-spasticity drug: tizanidine, diazepam, clonazepam, gabapentinoids (gabapentin, pregabalin). 6. Patients who have reached a daily dose of baclofen =100 mg, according to the centre's standard practice, or have not tolerated the prescribed dose. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients allergic to the drug. 2. Patients with cauda equina injury or other non-traumatic or non-traumatic non-medullary spinal cord injuries of less than 6 months of evolution. 3. Patients with severe psychiatric problems in treatment according to DSM-5 criteria. 4. Patients with comorbidities that contraindicate the use of the cannabinoids in the study according to the technical data sheet. 5. Patients with a previous history of drug abuse. 6. Patients who have consumed cannabis in the last month. 7. Pregnant or breastfeeding patients. 8. Patients with an intrathecal baclofen pump.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the clinical response to the anti-spasticity drug delta 9-tetrahydrocannabinol (THC) + cannabidiol (CBD) oral spray solution (Sativex®) in resistant spasticity due to spinal cord injury (SCI), using the numerical rating scale (NRS).;Secondary Objective: To assess the effect of treatment on muscle spasticity with the modified Ashworth spasticity scale (MAS). To assess the effect of treatment on spasm frequency with the Penn spasm scale. To assess the effect of treatment on the patient's impression of change with the PGIC scale. To assess changes in movement patterns, using hand-held sensors. To assess the effect of treatment on neuropathic pain symptoms, according to the NPSI scale. To assess the effect of treatment on sleep symptoms related to spasticity in LM, according to the PSQI questionnaire. To assess the effect of treatment on mood, according to the PHQ-9 scale. To assess the effect of treatment on the functional independence of the patient, according to the SCIM III scale. To assess the effect of treatment on the patient's quality of life, according to the WHOQoL-BREF scale. To assess the safety of treatment for spasticity in patients with chronic LM.;Primary end point(s): Percentage of patients achieving at least a 20% reduction from baseline on the NRS numerical rating scale (0-10) for spasticity symptoms. Treatment benefit will be assessed 3 months after starting treatment.;Timepoint(s) of evaluation of this end point: 3 months after the start of treatment.	—

Measure

Time frame

Main Objective: To assess the clinical response to the anti-spasticity drug delta 9-tetrahydrocannabinol (THC) + cannabidiol (CBD) oral spray solution (Sativex®) in resistant spasticity due to spinal cord injury (SCI), using the numerical rating scale (NRS).;Secondary Objective: To assess the effect of treatment on muscle spasticity with the modified Ashworth spasticity scale (MAS). To assess the effect of treatment on spasm frequency with the Penn spasm scale. To assess the effect of treatment on the patient's impression of change with the PGIC scale. To assess changes in movement patterns, using hand-held sensors. To assess the effect of treatment on neuropathic pain symptoms, according to the NPSI scale. To assess the effect of treatment on sleep symptoms related to spasticity in LM, according to the PSQI questionnaire. To assess the effect of treatment on mood, according to the PHQ-9 scale. To assess the effect of treatment on the functional independence of the patient, according to the SCIM III scale. To assess the effect of treatment on the patient's quality of life, according to the WHOQoL-BREF scale. To assess the safety of treatment for spasticity in patients with chronic LM.;Primary end point(s): Percentage of patients achieving at least a 20% reduction from baseline on the NRS numerical rating scale (0-10) for spasticity symptoms. Treatment benefit will be assessed 3 months after starting treatment.;Timepoint(s) of evaluation of this end point: 3 months after the start of treatment.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At 4 weeks and 3 months after the start of treatment.;Secondary end point(s): - Mean change in NRS spasticity score 0-10 at 4 weeks and 3 months after starting treatment. - Percentage of patients with at least 30% improvement from their baseline spasticity score on the NRS 0-10 scale (clinically relevant response) at 4 weeks and 3 months after starting treatment. - Mean change in MAS score at 4 weeks and 3 months after starting treatment. - Mean change in Penn Spasm Scale score at 4 weeks and 3 months after starting treatment. - Patient Global Impression of Change (PGIC) at 4 weeks and 3 months after starting treatment. - Changes in movement patterns, collected by portable ZurichMove IMU sensors (Zurich, Switzerland. https://zurichmove.com/), 3 months after starting treatment. - Change in neuropathic pain symptom intensity, according to NPSI, 4 weeks and 3 months after starting treatment. - Change in sleep pattern, according to PSQI, 4 weeks and 3 months after starting treatment. - Change in mood, according to PHQ-9 scale, at 4 weeks and 3 months after starting treatment. - Change in functional independence, according to the SCIM III scale, at 4 weeks and 3 months after starting treatment. - Change in quality of life, according to the WHOQoL-BREF scale, at 4 weeks and 3 months after starting treatment. - Safety of THC+CBD treatment will be assessed by collecting adverse events.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At 4 weeks and 3 months after the start of treatment.;Secondary end point(s): - Mean change in NRS spasticity score 0-10 at 4 weeks and 3 months after starting treatment. - Percentage of patients with at least 30% improvement from their baseline spasticity score on the NRS 0-10 scale (clinically relevant response) at 4 weeks and 3 months after starting treatment. - Mean change in MAS score at 4 weeks and 3 months after starting treatment. - Mean change in Penn Spasm Scale score at 4 weeks and 3 months after starting treatment. - Patient Global Impression of Change (PGIC) at 4 weeks and 3 months after starting treatment. - Changes in movement patterns, collected by portable ZurichMove IMU sensors (Zurich, Switzerland. https://zurichmove.com/), 3 months after starting treatment. - Change in neuropathic pain symptom intensity, according to NPSI, 4 weeks and 3 months after starting treatment. - Change in sleep pattern, according to PSQI, 4 weeks and 3 months after starting treatment. - Change in mood, according to PHQ-9 scale, at 4 weeks and 3 months after starting treatment. - Change in functional independence, according to the SCIM III scale, at 4 weeks and 3 months after starting treatment. - Change in quality of life, according to the WHOQoL-BREF scale, at 4 weeks and 3 months after starting treatment. - Safety of THC+CBD treatment will be assessed by collecting adverse events.

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Countries

Spain

Contacts

Public ContactDepartamento operaciones

Dynamic S.L.U. (Evidenze Clinical Research)

ensayosclinicos@evidenze.com

Outcome results

None listed

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