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Observational Natural History Study of Autosomal Dominant Retinitis Pigmentosa (adRP)
N/A
Waitlist Available
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to gain an understanding of how adRP progresses over time in patients with misfolded rod opsin mutations.
Eligible Conditions
- Retinitis Pigmentosa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2016 Phase 3 trial • 356 Patients • NCT0004899731%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Mood alteration-depression
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Observation of progression of disease over time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Observation
2016
Completed Phase 3
~25810
Find a Location
Who is running the clinical trial?
ShireLead Sponsor
456 Previous Clinical Trials
96,030 Total Patients Enrolled
Shire DirectorStudy DirectorTakeda
6 Previous Clinical Trials
4,000 Total Patients Enrolled