FindTrial
Sign In

NAC Attack, A Phase III, Multicenter, Randomized, Parallel, Double Masked, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral N-Acetylcysteine in Patients with Retinitis Pigmentosa

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501438-46-00
Enrollment
120
Registered
2023-04-06
Start date
2024-01-22
Completion date
Unknown
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Brief summary

The primary efficacy endpoint is to determine if the progressive loss in EZ width assessed as the cumulative loss of EZ (calculated as the area under the curve, AUC) between baseline and M45 is significantly smaller in eyes of participants taking NAC 1800 mg bid compared with eyes of participants taking placebo. EZ width will be measured on a spectral domain-optical coherence tomography (SD-OCT) scan through the fovea.

Detailed description

The secondary efficacy endpoints are to assess the relative efficacy in eyes of participants taking NAC 1800 mg bid compared with eyes of participants taking placebo on the basis of the following endpoints: • Change from baseline mean macular sensitivity measured by microperimetry (MP) at M45. • Change from baseline in BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at M45.

Interventions

DRUGFluimucil long 600 mg Brausetabletten
DRUGAcetylcysteine 600 mg PLACEBO
DRUGeffervescent tablets

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint is to determine if the progressive loss in EZ width assessed as the cumulative loss of EZ (calculated as the area under the curve, AUC) between baseline and M45 is significantly smaller in eyes of participants taking NAC 1800 mg bid compared with eyes of participants taking placebo. EZ width will be measured on a spectral domain-optical coherence tomography (SD-OCT) scan through the fovea.—

Secondary

MeasureTime frame
The secondary efficacy endpoints are to assess the relative efficacy in eyes of participants taking NAC 1800 mg bid compared with eyes of participants taking placebo on the basis of the following endpoints: • Change from baseline mean macular sensitivity measured by microperimetry (MP) at M45. • Change from baseline in BCVA measured by Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at M45.—

Countries

Austria, Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026