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NCT02908685 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants
A Phase 2 study of Muscular Atrophy, Spinal, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 231
- Enrollment target
- 20
- Study locations
NCT02908685 is a Phase 2 study of Muscular Atrophy, Spinal that has completed, run by Hoffmann-La Roche. The registered enrollment target is 231 participants, above the 60-participant average among 15 other Muscular Atrophy, Spinal trials with a reported enrollment target (285% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT02908685, a Phase 2 study of Muscular Atrophy, Spinal, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 231 participants
- Enrollment target
- 20
- Study locations
Study Summary
Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1) of Risdiplam for 12 weeks and a confirmatory part (Part 2) of Risdiplam for 24 months.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Risdiplam
Study Locations (20)
Other
- UZ Gent - Ghent
- UZ Leuven Gasthuisberg - Leuven
- Chr de La Citadelle - Liège
- Peking University First Hospital - Beijing
- Children's Hospital of Fudan University - Shanghai
- Clinical Medical Center Zagreb; University Hospital Rebro Department of Paediatrics - Zagreb
- Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique ? L?ESCALE - Bron
- Hopital Roger Salengro - Lille
- CHU de Nantes - Hotel Dieu - Nantes
- Hôpital Necker-Enfants Malades; Service de neuropédiatrie - Paris
- Hopital Armand Trousseau - Paris
- Universitätsklinikum Freiburg; Klinik für Neuropädiatrie und Muskelerkrankungen - Freiburg im Breisgau
Lazio
- IRCCS Ospedale Pediatrico Bambino Gesù; U.O. Malattie Neuromuscolari e Neurodegenerative - Rome
- Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile - Rome
California
- Stanford University Medical Center - Palo Alto
New York
- Columbia University Medical Center; The Neurological Institute of New York - New York
Rio de Janeiro
- Instituto de Puericultura E Pediatria Martagão Gesteira - Rio de Janeiro
Alberta
- Alberta Children's Hospital Division of Pediatric Neurology - Calgary
Ontario
- London Health Sciences Centre; Children's Hospital; Pediatrics - London
Quebec
- McGill University Health Centre - Glen Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2016-10-19 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02908685
The ClinicalTrials.gov registry entry for NCT02908685 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 60-participant average among 15 other Muscular Atrophy, Spinal trials with a reported enrollment target (285% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Muscular Atrophy, Spinal appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02908685 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Lazio, California.
Frequently Asked Questions
What is clinical trial NCT02908685 about?
NCT02908685 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants". Multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of Risdiplam in adult and pediatric participants with Type 2 and Type 3 SMA. The study consists of two parts, an exploratory dose finding part (Part 1...
What is the current status of trial NCT02908685?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 231 participants. The study started on 2016-10-19. Estimated completion is 2023-10-02.
What conditions does trial NCT02908685 study?
This clinical trial studies the following conditions: Muscular Atrophy, Spinal.
What interventions are being tested in trial NCT02908685?
The interventions under investigation include: Placebo (DRUG), Risdiplam (DRUG).
Who is sponsoring clinical trial NCT02908685?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02908685 being conducted?
This trial has 20 study locations across California, New York, Rio de Janeiro, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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