Medical Cannabis for Pediatric Moderate to Severe Complex Motor Disorders
Stephanie Libzon1, Lihi Bar-Lev Schleider2, Naama Saban2, Luda Levit2, Yulia Tamari1, Ilan Linder1, Tally Lerman-Sagie1, and Lubov Blumkin1
1 Pediatric Neurology Unit, Pediatric Movement Disorders Unit, Wolfson Medical Center, Holon, Sackler School of Medicine, Tel-Aviv University, Israel; 2 Research Department, Tikun Olam Ltd, Tel-Aviv, Israel
Motor disorders are developmental disorders in movement and coordination, which are manifested in motor awkwardness, spasticity, dystonia and more. Conventional drug treatment is very limited, especially among the pediatric population: some drugs can cause severe side effects, and some are not approved for children at all.
In this controlled clinical study, conducted in collaboration with the Department of Pediatric Movement Disorders at Wolfson Hospital and the Sackler Faculty of Medicine at Tel Aviv University, 25 children with complex motor disorders (mainly cerebral palsy) were randomly assigned to two groups and given Avidekel oil 1:6 or 1:20, for five months. Participants came for follow-up visits every month in which a physiotherapist filled out valid and reliable questionnaires for dystonia and spasticity and also took safety measures such as EEG and blood tests. Patients were followed up two months before starting treatment and for five months of treatment.
The results showed significant improvement in spasticity and dystonia, sleep difficulties, pain severity, and quality of life.
STUDY POPULATION: 25 patients with complex motor disorders, primarily cerebral palsy (16 males, mean age 7.15).
STUDY PRODUCT: Avidekel enriched 5% cannabis oil with 1:6 and 1:20 ratio.
- 5 (20.0%) children discontinued treatment during the 5 months of follow-up.
- Clinical efficacy – there was a significant improvement in spasticity, dystonia, and gross motor function.
- Improvement in quality of life – the score of a special quality of life questionnaire for children with cerebral palsy improved; there was also a significant improvement in mood, sleep, and pain.
- Improvement in gastrointestinal function and appetite – there was a significant improvement in gastrointestinal function and appetite.
- Side effects were rare and consisted only of vomiting and restlessness.
- CBD-enriched 5% cannabis oil with CBD:THC ratios of 6:1 and 20:1 is effective in reducing the severity of dystonia and spasticity, and improving motor function ability and quality of life.