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EMA401 in Post-herpetic Neuralgia
NCT03094195Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2017
- Primary completion
- Mar 2019
- Countries
- 19
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- olodanrigan
- Conditions
- postherpetic neuralgia (PHN)
01
Overview
Phase 2, randomised, double-blind trial of olodanrigan in postherpetic neuralgia (PHN) (3 arms), sponsored by Novartis. Primary endpoint: Change in Weekly Mean of the 24-hour Average Pain Score at 12 weeks. Started Jun 2017; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
EMA401 25mg BID
EMA401 25 mg orally twice daily
EMA401 100mg BID
EMA401 100 mg orally twice daily
Placebo BID
Matching placebo capsules orally twice daily
03
Who it enrols
Patients with post-herpetic neuralgia (pain > 6 months) and moderate to severe pain (NRS >= 4) who have failed at least 2 prior therapies. Excludes patients with significant renal/liver insufficiency, uncontrolled diabetes, or major depression.
04
Endpoints
Primary
Change in Weekly Mean of the 24-hour Average Pain Score
Secondary
Change in Weekly Mean 24-hour Average Pain Score
Change in Brief Pain Inventory-Short Form Interference Mean Total Score
Change in Weekly Mean of the 24-hour Worst Pain Score
Number of Participants Per Patient Global Impression of Change Category
Percentage of Patients Achieving at Least 30% Pain Reduction
Percentage of Patients Achieving at Least 50% Pain Reduction
Mean Change in Insomnia Severity Index
Change in Neuropathic Pain Symptom Inventory
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