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NCT03268096: DB-SEP15
Disability, MRI Lesions and Thickness of Retinal Fibers: Evaluation 15 Years After a First Episode of Demyelination
trial testing Cerebral MRI and Optical Coherence Tomography in Multiple Sclerosis in 182 participants. Completed in 3 November 2021.
3 November 2021
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 182 |
| Start date | 3 May 2017 |
| Primary completion | 3 November 2021 |
| Estimated completion | 3 November 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- Cerebral MRI and Optical Coherence Tomography
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
- Pathologic Processes — all drugs for Pathologic Processes →
- Tomography, Optical Coherence — all drugs for Tomography, Optical Coherence →
- Magnetic Resonance Imaging — all drugs for Magnetic Resonance Imaging →
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild — full company profile →
Who can join
Eligibility, any sex, with Multiple Sclerosis or Pathologic Processes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Knowledge of the evolution of multiple sclerosis (MS) and its long-term prognostic factors is essential to guide the therapeutic management. However, it remains partial and concerns above all data collected during the first years of the disease. The evolution towards disability can only be assessed after a follow-up of more than 10 years and does not depend solely on the initial inflammatory activity of the disease. We propose to realize a standardized clinical assessment, an optical coherence tomography (OCT) and a cerebral MRI 15 years after the first clinical manifestation of the disease. Clinical and paraclinical assessment will consist in the realization of additional MRI sequences in order to obtain more precise information on cerebral lesions (unconventional parameters). Optical coherence tomography (new generation device) will also be performed on both eyes to describe the thickness of the different layers of the retina. A clinical evaluation will be performed with the Expanded Disability Status Scale (EDSS). This study aims: 1. to describe the current clinical situation of patients (e.g. percentage of patients with moderate or severe disability) 2. to explore the associations between MRI parameters, those measured with OCT and clinical characteristics (disability) 3. to explore clinical and paraclinical prognostic factors of pejorative evolution (disability, severe cerebral atrophy, etc.)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03268096
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT03268096 (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 Fondation Ophtalmologique Adolphe de Rothschild
- Last refreshed: 22 April 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/NCT03268096.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing