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NCT04530955
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
NA trial testing Prometra II Programmable Pump - Flowonix Medical in Injuries, Spinal Cord in 92 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | Culicchia Neurological Clinic |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 24 September 2020 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 June 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prometra II Programmable Pump - Flowonix Medical
Conditions studied
- Injuries, Spinal Cord — all drugs for Injuries, Spinal Cord →
- CVA (Cerebrovascular Accident) — all drugs for CVA (Cerebrovascular Accident) →
- Traumatic Brain Injury — all drugs for Traumatic Brain Injury →
- MS (Multiple Sclerosis) — all drugs for MS (Multiple Sclerosis) →
Sponsor
Culicchia Neurological Clinic
Who can join
Adults 22 to 85, any sex, with Injuries, Spinal Cord or CVA (Cerebrovascular Accident). Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Comparison of spasticity control with Synchromed II versus Prometra II
Time frame: 3 months
To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II). NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospect
Sponsor's own description
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04530955
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Injuries, Spinal Cord
Currently open trials in the same condition.
- NCT04460872 — Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury · Phase 2 · 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 NCT04530955 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Culicchia Neurological Clinic
- Last refreshed: 24 September 2020
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/NCT04530955.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing