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

• Register: EUCTR
• Last refreshed on: 24 September 2018
• Main ID: EUCTR2015-004775-78-ES
• Date of registration: 11/05/2016
• Prospective Registration: Yes
• Primary sponsor: Convergence Pharmaceuticals Ltd
• Public title: Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
• Scientific 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
• Date of first enrolment: 28/07/2016
• Target sample size: 504
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004775-78
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Bulgaria, Czech Republic, France, Georgia, Italy, Latvia, Lithuania, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom

Contacts

• Name: N/A
• Affiliation: Convergence Pharmaceuticals Ltd

• Name: N/A
• Affiliation: Convergence Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
Key Inclusion Criteria:
- Men and women aged 18 to 75 years inclusive
- Has body weight > o =50 kg for men and > o = 45 kg for women
- Must have diagnosis of neuropathic PLSR
- Has duration of neuropathic (leg) pain of at least 6 months before Screening

Other protocol-defined inclusion/exclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 104

Exclusion criteria:
Key Exclusion Criteria:
- Has planned surgical intervention for PLSR within the duration of the study.
- 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

Other protocol-defined inclusion/exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Neuropathic Pain From Lumbosacral Radiculopathy
MedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0 Level: PT Classification code 10050219 Term: Lumbar radiculopathy System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: BIIB074
Product Code: BIIB074
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Raxatrigine (proposed)
CAS Number: 934240-31-0
Current Sponsor code: BIIB074
Other descriptive name: CNV1014802A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Product Name: BIIB074
Product Code: BIIB074
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Raxatrigine (proposed)
CAS Number: 934240-31-0
Current Sponsor code: BIIB074
Other descriptive name: CNV1014802A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.

Secondary Objective: A secondary objective is 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.

Timepoint(s) of evaluation of this end point: Week 14 last 24-hour period.

Primary end point(s): The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS.
Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period.
*Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Points 1; 2; 6 - Week 14
Point 3 - Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit.
Point 4-11 -Change from Baseline (Week 2) to Week 14

Secondary end point(s): Efficacy endpoints in neuropathic pain:
1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a ?50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14
2. 30% neuropathic daily pain reduction response (yes/no) at Week 14, where a response is defined as a ?30% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14?
3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit
Efficacy endpoint in low back pain:
4. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to rate their overall low back pain for the last 24-hour period Other efficacy endpoints:
5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14, where a responder is defined as either ?much improved? or ?very much improved?
6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index
7. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality
8.Change from Baseline (Week 2) to Week 14 in the Brief Pain Inventory (BPI)- Interference index
9. Change from Baseline (Week 2) to Week 14 in the BPI-Pain index
10. Change from Baseline (Week 2) to Week 14 on the EuroQoL 5-Dimension
5-Level Questionnaire (EQ-5D-5L) health index
11. Change from Baseline (Week 2) to Week 14 in the Short Form 36 Questionnaire (SF-36)
12. Amount of rescue medication used (dosage/day)
Another secondary objective is to investigate the safety and tolerability of 2 dose regimens of BIIB074.
The endpoints that relate to this objective are as follows:
? AEs and SAEs
? Vital signs
? ECG parameters
? Laboratory safety tests
? Columbia-Suicide Severity Rating Scale (C-SSRS)
Another secondary objective is to characterize the PK of BIIB074 in this population.

Secondary ID(s)

1014802-203

2015-004775-78-LV

Source(s) of Monetary Support

Convergence Pharmaceuticals Ltd