DS-5565 Phase III Study for Post-herpetic Neuralgia

Daiichi Sankyo

Status: Completed

Conditions: Post-Herpetic Neuralgia

Treatments: Drug: Placebo; Drug: DS-5565

Study type: Interventional

Funder types: Industry

Identifiers

NCT02318719

DS5565-A-J304

Details and patient eligibility

About

Investigate the efficacy and safety of DS-5565 in subjects with Post-Herpetic Neuralgia (PHN) in comparison to placebo

Full description

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian subjects with PHN receiving DS-5565 versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of DS-5565 in subjects with PHN.

Enrollment: 765 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PHN defined as pain present for more than 3 months after herpes zoster skin rash at screening
• At screening, a pain scale of ≥ 40 mm

Exclusion criteria

• Previous use of neurolytic block

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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765 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo (14-weeks)

Treatment:

Drug: Placebo

DS-5565 15 mg Group

Experimental group

Description:

DS-5565 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Treatment:

Drug: DS-5565

DS-5565 20 mg Group

Experimental group

Description:

DS-5565 20 mg, oral administration, Treatment period; 1-week titration and 13-weeks fixed dose

Treatment:

Drug: DS-5565

DS-5565 30 mg Group

Experimental group

Description:

DS-5565 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose

Treatment:

Drug: DS-5565