A phase II trial to investigate the safety of early high dose methylprednisolone in acute leprous neuritis and leprosy type 1 reactions with neuritis in Nepal

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31894035

Enrollment

Registered

2006-04-04

Start date

2005-12-07

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Leprosy Infections and Infestations Leprosy

Interventions

Study arm receives intravenous (IV) methylprednisolone in the first three days of type 1 reaction or acute neuritis treatment. The control arm receives a standard treatment of 40 mg prednisolone plus

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Those with type 1 reaction with new nerve function impairment 2. Age 16-65 years

Exclusion criteria

Exclusion criteria: 1. Type 1 reaction without new nerve function impairment 2. Systemic corticosteroids in the preceding three months 3. Contraindications to steroids 4. Pregnancy 5. Severe active infection 6. Severe intercurrent illness

Design outcomes

Primary

Measure	Time frame
Nerve function	—

Secondary

Measure	Time frame
Amount of additional steroid required	—

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026