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NCT04984278 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 56
- Enrollment target
NCT04984278: Clinical Trial Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT04984278 is a Phase 3 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 56 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04984278, a Phase 3 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 \[LLMT-6\]) in participants with multiple sclerosis (MS). LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS)-transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body.
Primary Outcome
LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.
Interventions
- DRUG Placebo
- DRUG Nabiximols
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2022-11-11 |
| Phase | Phase 3 |
Why NCT04984278 stopped before completion
NCT04984278 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04984278 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04984278 about?
NCT04984278 is a clinical study titled "Evaluation of the Effect of Nabiximols Oromucosal Spray on Clinical Measures of Spasticity in Participants With Multiple Sclerosis". This study will be conducted to evaluate the effect of multiple doses of nabiximols compared with placebo on a clinical measure of velocity-dependent muscle tone in the lower limbs (Lower Limb Muscle Tone-6 \[LLMT-6\]) in participants with multiple sclerosis (MS). LLMT-6 is defined as the average of...
What is the current status of trial NCT04984278?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 56 participants. The study started on 2021-08-16. Estimated completion is 2022-11-11.
What interventions are being tested in trial NCT04984278?
The interventions under investigation include: Placebo (DRUG), Nabiximols (DRUG).
Who is sponsoring clinical trial NCT04984278?
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 NCT04984278's enrollment target sits among peer trials
56 1827th of 2000 higher than 167 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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