Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2015-004796-68-ES
• Date of registration: 30/09/2016
• Prospective Registration: Yes
• Primary sponsor: Convergence Pharmaceuticals Ltd
• Public title: Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
• Scientific title: An Uncontrolled, Open-Label Extension Study to Evaluate the Long Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
• Date of first enrolment: 21/11/2016
• Target sample size: 403
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004796-68
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
• 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, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed:
1.Is able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
2.Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who discontinued double-blind study treatment but continued to return for study visits through Week 14 (Day 99) and document their pain scores are eligible unless there are safety concerns
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 323
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion criteria:
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed:
1.Had a major protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203).
2.Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE.
3.Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in the double-blind phase of the Phase 2b study.
4.Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99) visit.
5.Other unspecified reasons that, in the opinion of the Investigator or Convergence Pharmaceuticals, make the subject unsuitable for enrollment.


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

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

Product Name: BIIB074
Product Code: BIIB074
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not available
CAS Number: 934240-31-0
Current Sponsor code: BIIB074
Other descriptive name: CNV1014802A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Product Name: BIIB074
Product Code: BIIB074
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Not available
CAS Number: 934240-31-0
Current Sponsor code: BIIB074
Other descriptive name: CNV1014802A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)

Secondary Objective: Secondary objectives of the study are:
- To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR
-To evaluate the impact of treatment with BIIB074 on quality of life

Primary end point(s): The primary endpoints that relate to this objective are as follows:
1. AEs and SAEs
2. Vital signs
3. ECG parameters
4. Laboratory safety tests
5. Columbia-Suicide Severity Rating Scale (C-SSRS)

Timepoint(s) of evaluation of this end point: 1.-5. From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)

Main Objective: The primary objective of the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.

Secondary Outcome(s)

Secondary end point(s): Efficacy endpoints and timepoints in neuropathic pain:
1. Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain* score on the 11 point Pain Intensity Numerical Rating Scale (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 on Day 1 of Study 1014802-203.
2. 50% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a > o = 50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52
3. 30% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a > o = 30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52
4. Changes from Baseline in the weekly average of the daily neuropathic pain score at each visit
•Efficacy endpoint in low back pain:
5. Change from Baseline to Week 52 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.
The endpoints that relate to the impact of treatment with BIIB074 on quality of life are as follows:
6. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 52, where a responder is defined as either “much improved” or “very much improved”
7. Change from Baseline to Week 52 on the Oswestry Disability Index
8. Change from Baseline to Week 52 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
9. Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference index
10. Change from Baseline (Week 2) to Week 52 in the BPI-Pain index
11. Change from Baseline to Week 52 on the EuroQoL 5 Dimension 5-Level Questionnaire (EQ 5D-5L) health index
12. Change from Baseline to Week 52 in the Short Form 36 Questionnaire (SF 36)

Timepoint(s) of evaluation of this end point: For timepoints of secondary endpoints please refer to E.5.2.

Secondary ID(s)

1014802-204

2015-004796-68-LV

Source(s) of Monetary Support

Convergence Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date:
Contact: