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NCT01898520
The Efficacy, Safety and Tolerability of Sativex as an Adjunctive Treatment to Existing Anti-spasticity Medications in Children Aged 8 to 18 Years With Spasticity Due to Cerebral Palsy or Traumatic Central Nervous System Injury Who Have Not Responded Adequately to Their Existing Anti-spasticity Medications: a Parallel Group Randomised, Double-blind, Placebo-controlled Study Followed by a 24-week Open Label Extension Phase
Phase 3 trial testing Sativex in Cerebral Palsy in 72 participants. Completed in 1 March 2017.
1 September 2016
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 December 2013 |
| Primary completion | 1 September 2016 |
| Estimated completion | 1 March 2017 |
| Sites | 14 locations across Czechia, Israel, United Kingdom |
Drugs / interventions tested
- Sativex — full drug profile →
- Placebo
Conditions studied
- Cerebral Palsy — all drugs for Cerebral Palsy →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
Adults 8 to 18, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline to the end of 12 weeks' treatment in mean spasticity 0-10 NRS score
Time frame: Day 0 - Day 84
The spasticity 0-10 NRS was completed daily at bedtime using a paper study diary. The difference between spasticity and spasm was clearly explained to the caregiver. The primary caregiver was asked the following question: "This question is about your child's muscles and how soft or tight/hard they have felt today. Think carefully about how your child's muscles have felt today and circle a number f
Sponsor's own description
A study to assess the effects of Sativex treatment on spasticity in a population of children and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous system injury. Efficacy (ability to improve symptoms), safety and tolerability will be monitored.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Medical cannabis: aligning use to evidence-based medicine approach.
Bar-Lev Schleider L, Abuhasira R, Novack V. · · 2018 · cited 21× · PMID 29859014 · DOI 10.1111/bcp.13657 -
Medical Cannabis in Pediatric Oncology: Friend or Foe?
Malach M, Kovalchuk I, Kovalchuk O. · · 2022 · cited 8× · PMID 35337156 · DOI 10.3390/ph15030359
Verify or expand the search:
- PubMed search for NCT01898520
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sativex
Trials testing the same drug.
- NCT05503147 — Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan) · Phase 1 · unknown
- NCT03936907 — Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets Wi · Phase 1 · completed
- NCT03201835 — 5-Way Crossover Study to Compare the Safety, Tolerability and Pharmacokinetics of New Oral Cannabinoid Formulations Admi · Phase 1 · completed
Other recruiting trials for Cerebral Palsy
Currently open trials in the same condition.
- NCT07524972 — Antenatal Magnesium Sulphate in High-Risk Preterm Patients · Phase 3 · recruiting
- NCT07432789 — Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performa · NA · recruiting
- NCT07466914 — Constipation in Children With Cerebral Palsy · active not recruiting
- NCT05901259 — The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes · recruiting
- NCT07342348 — Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy · NA · recruiting
Other Jazz Pharmaceuticals trials
Trials by the same sponsor.
- NCT07533942 — A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma · Phase 2 · not yet recruiting
- NCT07459634 — A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC · Phase 2 · not yet recruiting
- NCT07377539 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07282587 — Study of ONC206 (JZP3507) in Advanced Pheochromocytoma and Paraganglioma · Phase 2 · recruiting
- NCT07233239 — A Study to Evaluate the Efficacy and Safety of Cannabidiol Oral Solution (CBD-OS [GWP42003-P, JZP926]) for the Treatment · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01898520 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
- Last refreshed: 19 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01898520.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing