Dronabinol Successfully Treated Severe Spasticity in Children With Complex Neurological Conditions | Research

The takeaway

In 16 children and young adults with treatment-resistant spasticity receiving palliative care, dronabinol (synthetic THC) abolished or markedly improved spasticity in 75% of cases with minimal side effects.

Read this if you care for a child with severe spasticity or are interested in cannabinoid use in pediatric palliative care.

75% of children showed abolished or markedly improved spasticity

What the researchers found

Sixteen children, adolescents, and young adults (ages 1.3-26.6 years) with complex neurological conditions received dronabinol for severe spasticity that had not responded to other treatments. This was provided by a specialized pediatric palliative care team in a home-care setting.

The results were promising: 12 of 16 patients (75%) experienced abolished or markedly improved spasticity. Two patients showed uncertain effects, and two did not benefit.

Treatment was sustained for extended periods, with a median duration of 181 days (range 23-1,429 days). Effective doses varied widely from 0.08 to 1.0 mg/kg/day, with a median of 0.33 mg/kg/day.

When administered using a gradual dose escalation approach, side effects were rare and mild, consisting of only vomiting and restlessness (one patient each). No serious or lasting side effects occurred, even in very young children or over extended treatment periods.

Why it matters

Children with severe neurological conditions often develop treatment-resistant spasticity that significantly impairs quality of life. This study provides some of the first evidence that synthetic THC can be safely and effectively used in pediatric palliative care for this purpose, with some children as young as 15 months.

The numbers in context

16 patients, ages 1.3-26.6 years. 12/16 (75%) showed abolished or marked improvement. Median treatment: 181 days (up to 1,429 days). Effective dose: 0.08-1.0 mg/kg/day (median 0.33). Side effects: 2 patients (vomiting and restlessness). No serious adverse events.

How the study worked

Open, uncontrolled, retrospective study of 16 patients treated with dronabinol (2.5% THC oil solution) between December 2010 and April 2015 by a pediatric palliative care team. Therapeutic efficacy and side effects were closely monitored.

What this study cannot tell us

Open, uncontrolled, retrospective design with no comparison group. Small sample size. Heterogeneous patient population and neurological conditions. Placebo effects cannot be excluded. No standardized spasticity scales were described.

How to read the evidence

Retrospective case series with no controls. Provides initial safety and efficacy data but cannot establish causal effectiveness.

When this study was published

Published in 2016. Pediatric cannabinoid research has expanded, particularly with CBD for epilepsy (Epidiolex).

The bigger picture

Cannabis-based medicines remain largely unapproved for pediatric use in most countries. This study from a palliative care context, where quality of life is the primary goal, provides real-world evidence supporting the safety and efficacy of cannabinoids in children with severe, treatment-resistant conditions.

Questions still open

Should dronabinol be studied in a controlled trial for pediatric spasticity? What is the optimal dose range for different age groups? How does the long-term safety profile compare to other antispasticity medications in children?

Common questions

Can THC be used safely in children?

In this study, synthetic THC (dronabinol) was administered to children as young as 15 months for severe spasticity. With gradual dose escalation, side effects were rare and mild, with no serious adverse events over treatment periods up to nearly 4 years.

How effective was dronabinol for spasticity in children?

75% of children (12 of 16) experienced abolished or markedly improved spasticity. Treatment was sustained for a median of 181 days, suggesting durable benefit.

Read the original research

Effective treatment of spasticity using dronabinol in pediatric palliative care.

European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society, 20(6), 898-903

View on PubMed ↗Publisher’s paper ↗

Citation

Kuhlen, Michaela; Hoell, Jessica I; Gagnon, Gabriele; Balzer, Stefan; Oommen, Prasad T; Borkhardt, Arndt; Janßen, Gisela. (2016). Effective treatment of spasticity using dronabinol in pediatric palliative care.. European journal of paediatric neurology : EJPN : official journal of the European Paediatric Neurology Society, 20(6), 898-903. https://doi.org/10.1016/j.ejpn.2016.07.021