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NCT02901106: SURV-SEP
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
Phase 4 trial testing Dimethyl fumarate in Multiple Sclerosis, Relapsing-Remitting in 11 participants. Terminated before completion.
17 October 2017
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 23 May 2017 |
| Primary completion | 17 October 2017 |
| Estimated completion | 17 October 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- Dimethyl fumarate (DIMETHYL FUMARATE) — full drug profile →
Conditions studied
- Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild — full company profile →
Who can join
18 and older, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS. Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease. It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment. The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02901106
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dimethyl fumarate
Trials testing the same drug.
- NCT06513533 — Dimethyl Fumarate in Adrenomyeloneuropathy · Phase 2, PHASE3 · recruiting
- NCT05959759 — Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms. · Phase 4 · unknown
- NCT05658484 — A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China · Phase 4 · completed
- NCT04890353 — Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke · Phase 1, PHASE2 · terminated
- NCT04890379 — Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage · Phase 2 · withdrawn
Other recruiting trials for Multiple Sclerosis, Relapsing-Remitting
Currently open trials in the same condition.
- NCT06408259 — Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relap · Phase 3 · recruiting
- NCT06569550 — Fatigue Alleviation Through Neuromodulating Therapy in Multiple Sclerosis · NA · recruiting
- NCT06389968 — Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis · NA · recruiting
- NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients · active not recruiting
- NCT06715436 — Multiple Sclerosis and the Effects of Ketogenic Diet Therapy · NA · recruiting
Other Fondation Ophtalmologique Adolphe de Rothschild trials
Trials by the same sponsor.
- NCT04701619 — Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE) · NA · not yet recruiting
- NCT04763161 — Immuno-inflammation in the Acute Phase of an Ischaemic Cerebral Accident Managed by Decompressive Hemicraniectomy: a Cas · not yet recruiting
- NCT06264531 — Efficacy and Safety of Anti-angiogenic Therapy With IV Bevacizumab in Patients With Symptomatic Cerebral Arteriovenous M · Phase 2, PHASE3 · recruiting
- NCT06895044 — Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study · recruiting
- NCT06644196 — Creation of a Database of Images of the Eye With the Holographic Doppler Laser · 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 NCT02901106 (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: 9 January 2019
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/NCT02901106.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing