Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

Lumbosacral Radiculopathy Clinical Trial

— RELAY-1  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935608
• Other study ID #: 1014802-203
• Secondary ID: 2015-004775-78
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2016
• Est. completion date: August 6, 2018

Study information

• Verified date: August 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

Description:

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 502
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Has body weight =50 kg for men and =45 kg for women

• Must have diagnosis of neuropathic PLSR

• Has duration of neuropathic (leg) pain of at least 6 months before Screening

• Has an intensity of =4 and =9 on the Numerical Rating Scale based on a paper-based question at Screening and on Day 1 that asks for the average pain intensity of neuropathic (leg) pain due to PLSR over the last week

Key Exclusion Criteria:

• Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)

• Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination

• Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Neuralgia
• Radiculopathy

Intervention

Drug:
• BIIB074
Administered as specified in the treatment arm
• Placebo
Matched placebo

Locations

Country	Name	City	State
Austria	Research Site	Klagenfurt
Belgium	Research Site	Leuven
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Veliko Tarnovo
Czechia	Research Site	Beroun
Czechia	Research Site	Chocen
Czechia	Research Site	Litomerice
Czechia	Research Site	Litomysl
Czechia	Research Site	Ostrava
Czechia	Research Site	Prachatice
Czechia	Research Site	Prague
Czechia	Research Site	Prague
Czechia	Research Site	Prague
Czechia	Research Site	Prague
Czechia	Research Site	Prague
Czechia	Research Site	Zlin
France	Research Site	Paris
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Georgia	Research Site	Tbilisi
Italy	Research Site	Milan
Italy	Research Site	Rome
Latvia	Research Site	Liepaja
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Netherlands	Research Site	Nieuwegein
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Craiova
Serbia	Research Site	Belgrade
Serbia	Research Site	Belgrade
Slovakia	Research Site	Banská Bystrica
Slovakia	Research Site	Dolný Kubín
Slovakia	Reasearch Site	Dubnica nad Váhom
Slovakia	Research Site	Krompachy
Slovakia	Research Site	Pruske
Slovakia	Research Site	Spišská Nová Ves
Spain	Research Site	Barcelona
Spain	Research Site	Elche
Spain	Research Site	Granada
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	London
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Czechia,  France,  Georgia,  Italy,  Latvia,  Netherlands,  Romania,  Serbia,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)	Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=pain as bad as you can imagine.	Week 14
Secondary	50% neuropathic daily pain reduction response	Response is defined as a =50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14.	At Week 14
Secondary	30% neuropathic daily pain reduction response	Response is defined as a =30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 14.	At Week 14
Secondary	Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit		Week 14
Secondary	Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain	Participants will be asked every evening to rate their overall low back pain for the last 24-hour period	Week 14
Secondary	Number of Patient Global Impression of Change (PGIC) responders	PGIC is a 7-point, self-report scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	At Week 14
Secondary	Change from Baseline to Week 14 on the Oswestry Disability Index	This is a 10-item questionnaire that evaluates how back (or leg) pain affects the ability to manage in everyday life. Each question is rated on a 5 point scale with higher scores indicating higher level of pain.	Week 14
Secondary	Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)	Participants will be asked every morning to rate on the 11-point S-NRS how leg pain interfered with their sleep quality, where 0=no pain and 10=Pain completely interfered with sleep.	Week 14
Secondary	Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index	BPI Interference Index is an 11-point numeric rating scale (0 - no interference to 10 - interferes completely) to assess pain-related interference in 7 areas: general activity, mood, walking ability, normal work, including outside the home and housework, relations with other people, enjoyment of life and sleep.	Week 14
Secondary	Change from Baseline to Week 14 in the BPI-Pain index	BPI- Pain Index for pain intensity is used to assess potential pain quality descriptors that may describe participants' pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).	Week 14
Secondary	Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index	The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.	Week 14
Secondary	Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)	SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.	Week 14
Secondary	Amount of rescue medication used per day		Day 1 to Week 15
Secondary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Week 15
Secondary	Number of participants with clinically significant vital sign abnormalities		Up to Week 15
Secondary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to Week 15
Secondary	Number of participants with clinically significant laboratory assessment abnormalities		Up to Week 15
Secondary	Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a suicidal ideation rating used to evaluate suicidality in children ages 12 and up. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."	Up to Week 15
Secondary	Area under the concentration-time curve over the dosing period (AUCtau) at steady state		30 min prior to dosing up to 8 hours post dose
Secondary	Maximum concentration (Cmax)		30 min prior to dosing up to 8 hours post dose