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NCT04203498 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
NCT04203498: Clinical Trial Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT04203498 is a Phase 3 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 139 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04203498, a Phase 3 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
Study Summary
This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).
Primary Outcome
The change in the average daily spasm count was assessed compared to the baseline period.
Interventions
- DRUG Placebo
- DRUG Nabiximols
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 3 |
Why NCT04203498 stopped before completion
NCT04203498 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04203498 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04203498 about?
NCT04203498 is a clinical study titled "Safety and Effectiveness of Nabiximols Oromucosal Spray as Add-on Therapy in Participants With Spasticity Due to Multiple Sclerosis". This trial is being conducted to demonstrate the efficacy of nabiximols, compared with placebo, when added to standard of care, in the treatment of muscle spasms associated with multiple sclerosis (MS).
What is the current status of trial NCT04203498?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2020-10-01. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT04203498?
The interventions under investigation include: Placebo (DRUG), Nabiximols (DRUG).
Who is sponsoring clinical trial NCT04203498?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04203498's enrollment target sits among peer trials
139 1577th of 2000 higher than 424 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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