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NCT00702468
A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®.
Phase 3 trial testing Sativex in Spasticity in 36 participants. Completed in 1 January 2009.
1 January 2009
Quick facts
| Lead sponsor | Jazz Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 36 |
| Start date | 1 November 2007 |
| Primary completion | 1 January 2009 |
| Estimated completion | 1 January 2009 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Sativex — full drug profile →
- Placebo
Conditions studied
- Spasticity — all drugs for Spasticity →
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
Sponsor
Jazz Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Spasticity or Multiple Sclerosis. 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.
-
Number of Subjects Who Experience Treatment Failure.
Time frame: Week 1- Week 5
The time to treatment failure was calculated as the number of days from the first day of treatment up to the day of treatment failure. The day of treatment failure was the earliest of:the day of premature cessation of study medication;the first day of the longest period, ending on the last day of treatment, where the mean spasticity NRS had increased by at least 20% and at least 1 unit from the tr
Sponsor's own description
The purpose of this study is to evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to Multiple Sclerosis (MS) who have been receiving long-term benefit from treatment with Sativex®.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2 -
Safety Considerations in Cannabinoid-Based Medicine.
Gottschling S, Ayonrinde O, Bhaskar A, Blockman M, et al · · 2020 · cited 30× · PMID 33299341 · DOI 10.2147/ijgm.s275049 -
Placebo effects in a multiple sclerosis spasticity enriched clinical trial with the oromucosal cannabinoid spray (THC/CBD): dimension and possible causes.
Di Marzo V, Centonze D. · · 2015 · cited 9× · PMID 25475413 · DOI 10.1111/cns.12358
Verify or expand the search:
- PubMed search for NCT00702468
- 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 Spasticity
Currently open trials in the same condition.
- NCT05926596 — Leg Stretching Using an Exoskeleton on Demand for People With Spasticity · NA · recruiting
- NCT07466823 — Classification of Upper and Lower Limb Spasticity Patterns and Their Impact on Quality of Life in Patients With Multiple · recruiting
- NCT07273591 — Effects of Low-level Laser Therapy on Spasticity and Gait Parameters in Chronic Stroke Patients With Spastic Plantar Fle · NA · recruiting
- NCT06811142 — Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence · EARLY_PHASE1 · active not recruiting
- NCT06782464 — Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder · 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 NCT00702468 (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: 7 April 2023
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/NCT00702468.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing