Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2015-004796-68-SK |
Date of registration:
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26/09/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
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Scientific title:
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An Uncontrolled, Open-Label Extension Study to Evaluate the Long Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy |
Date of first enrolment:
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29/11/2016 |
Target sample size:
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403 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004796-68 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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Czech Republic
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France
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Georgia
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Italy
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Latvia
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Netherlands
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Romania
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Serbia
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Slovakia
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Spain
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United Kingdom
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Contacts
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Name:
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N/A
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Address:
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Innovation House, 70 Norden Road
SL6 4AY
Maidenhead
United Kingdom |
Telephone:
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Email:
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clinicaltrials@biogen.com |
Affiliation:
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Biogen Idec Research Limited |
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Name:
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N/A
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Address:
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Innovation House, 70 Norden Road
SL6 4AY
Maidenhead
United Kingdom |
Telephone:
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Email:
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clinicaltrials@biogen.com |
Affiliation:
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Biogen Idec Research Limited |
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Key inclusion & exclusion criteria
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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 Biogen, make the subject unsuitable for enrollment.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Neuropathic Pain
From Lumbosacral Radiculopathy
MedDRA version: 20.0
Level: LLT
Classification code 10054095
Term: Neuropathic pain
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0
Level: PT
Classification code 10050219
Term: Lumbar radiculopathy
System Organ Class: 10029205 - Nervous system disorders
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: Vixotrigine Product Code: BIIB074 Pharmaceutical Form: Coated tablet INN or Proposed INN: Vixotrigine 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: Vixotrigine Product Code: BIIB074 Pharmaceutical Form: Coated tablet INN or Proposed INN: Vixotrigine CAS Number: 934240-31-0 Current Sponsor code: BIIB074 Other descriptive name: CNV1014802A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): The primary endpoint that relates to this objective is the incidence of AEs and SAEs during the 12-month open label period.
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Main Objective: The primary objective of the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.
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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
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Timepoint(s) of evaluation of this end point: From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)
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Secondary Outcome(s)
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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 =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 =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)
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Timepoint(s) of evaluation of this end point: For timepoints of secondary endpoints please refer to E.5.2.
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Secondary ID(s)
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1014802-204
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2015-004796-68-LV
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Source(s) of Monetary Support
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Biogen Idec Research Limited
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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