Brief Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

452

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach

1 country

78 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

November 28, 2011

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2012

Completed

8.3 years until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed

Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

December 19, 2011

Results QC Date

November 3, 2020

Last Update Submit

December 8, 2020

Conditions

Diabetic Peripheral Neuropathy

Keywords

Keywords: pain, diabetes, neuropathy

Outcome Measures

Primary Outcomes (1)

Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point \[scale of 0 to 10\] versus placebo).
Baseline up to Week 5 postdose, up to 10 months total follow up

Secondary Outcomes (12)

Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Baseline up to Week 5 postdose, up to 10 months total follow up
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Baseline up to Week 5 postdose, up to 10 months total follow up
+7 more secondary outcomes