Trials / Unknown
UnknownNCT05884281
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roflumilast | 0.5 mg once daily for treatment period |
| DRUG | Placebo | Placebo for treatment period |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2023-06-01
- Last updated
- 2023-06-01
Source: ClinicalTrials.gov record NCT05884281. Inclusion in this directory is not an endorsement.