|
Main
|
|
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:
|
EUCTR |
|
Last refreshed on:
|
25 November 2019 |
|
Main ID: |
EUCTR2011-003507-38-GB |
|
Date of registration:
|
20/10/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Long-Term Prolonged-Release Fampridine Treatment and Quality of Life
|
|
Scientific title:
|
An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects with Multiple Sclerosis |
|
Date of first enrolment:
|
06/01/2012 |
|
Target sample size:
|
800 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003507-38 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
Australia
|
Belgium
|
Denmark
|
France
|
Germany
|
Ireland
|
Italy
|
Netherlands
|
|
Portugal
|
Sweden
|
United Kingdom
| | | | | |
|
Contacts
|
|
Name:
|
Not Available
|
|
Address:
|
Innovation House, 70 Norden Road
SL6 4AY
Maidenhead
United Kingdom |
|
Telephone:
|
|
|
Email:
|
enablestudy@biogenidec.com |
|
Affiliation:
|
Biogen Idec Research Limited |
|
|
Name:
|
Not Available
|
|
Address:
|
Innovation House, 70 Norden Road
SL6 4AY
Maidenhead
United Kingdom |
|
Telephone:
|
|
|
Email:
|
enablestudy@biogenidec.com |
|
Affiliation:
|
Biogen Idec Research Limited |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit or at the timepoint specified in the individual eligibility criterion listed:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent.
3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria (Section 22.1 [Polman et al, 2011]) as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration.
4. Have a walking impairment as determined by the Investigator.
5. Able to perform the T25FW (Section 22.2) test with or without a walking aid.
6. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15.5.3.
7. Able to understand and comply with the requirements of the protocol.
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 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
Exclusion criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria are met at the Screening Visit or at any time during the screening period, or at the timepoint specified in the individual eligibility criterion listed:
Medical History
1. Known allergy to pyridine-containing substances or to any of the inactive ingredients (see Section 12.1) in the prolonged-release fampridine tablet.
2. Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood.
3. An estimated CrCl of <80 mL/minute.
4. Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]).
Miscellaneous
5. Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. Female subjects of childbearing potential who have a positive pregnancy test at the Screening Visit may not participate in this study.
6. Female subjects who are currently breastfeeding.
7. Previous exposure to fampridine.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Multiple Sclerosis
MedDRA version: 14.1
Level: PT
Classification code 10028245
Term: Multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
|
|
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
|
|
Intervention(s)
|
Trade Name: Fampyra
Product Name: Fampridine
Product Code: BIIB041
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Current Sponsor code: BIIB041
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
|
|
Primary Outcome(s)
|
Secondary Objective: The secondary objectives of this study are as follows:
1) Compare the change in the PCS of the SF-36 between treatment responders and non-responders (treatment discontinued at Week 4).
2)Evaluate change from baseline in additional QoL measures among treatment responders as well as changes from baseline in treatment responders versus non-responders.
3)Assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.
|
|
Main Objective: The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.
|
|
Timepoint(s) of evaluation of this end point: baseline and week 12, 24, 36, 48 and 50
|
|
Primary end point(s): Change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolonged-release fampridine.
|
|
Secondary Outcome(s)
|
Timepoint(s) of evaluation of this end point: 1)baseline and week 12, 24, 36, 48 and 50
2)baseline and week 12, 24, 36, 48 and 50
3)baseline and week 12, 24, 36, 48 and 50
4)baseline and week 12, 24, 36, 48 and 50
5)Throughout the study
|
Secondary end point(s): 1)Comparison of the change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolonged-release fampridine and those who do not.
2)Change from baseline in additional QoL measures over Months 3, 6, 9, and 12 among responders as well as comparisons in change from baseline between responders and non-responders:
-Individual components and mental component scale (MCS) of the SF-36
-Multiple Sclerosis Impact Scale (MSIS-29) Physical and Psychological Score
-Activities Limitation scale of the Patient-Reported Indices for Multiple Sclerorsis (PRIMUS)
-EuroQoL descriptive system of health-related quality of life states consisting of 5 dimensions (questionnaire; EQ-5D)
-Work Productivity and Activity Impairment (WPAI)-Specific Health Problem (SHP) questionnaire
3)Change in QoL measures among responders stratified by disease type.
4)Change in QoL measures between responders and non-responders not taking additional MS therapy.
5)Safety of prolonged-release fampridine will be assessed by:
-the number and proportion of subjects with adverse events (AEs) and serious adverse events (SAEs)
|
|
Source(s) of Monetary Support
|
|
Biogen Idec Research Limited
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
|
|