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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: EUCTR
Last refreshed on: 23 November 2020
Main ID:  EUCTR2020-002438-34-DK
Date of registration: 11/06/2020
Prospective Registration: Yes
Primary sponsor: Department of Neurology, Odense University Hospital
Public title: Fampridine for treatment of functional disability in patients with immune mediated polyneuropathy
Scientific title: Fampridine for treatment of residual neurological deficits in patients treated with immunoglobulins for chronic inflammatory demyelinating polyneuropathy
Date of first enrolment: 19/08/2020
Target sample size: 40
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002438-34
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Denmark
Contacts
Name: Neuromuscular Clinic   
Address:  J. B. Winsløws Vej 4 5000 Odense Denmark
Telephone: 004565412471
Email: soeren.sindrup@rsyd.dk
Affiliation:  Odense University Hospital
Name: Neuromuscular Clinic   
Address:  J. B. Winsløws Vej 4 5000 Odense Denmark
Telephone: 004565412471
Email: soeren.sindrup@rsyd.dk
Affiliation:  Odense University Hospital
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age = 18 and = 80 years.
2. Diagnosis with CIDP or MGUS-associated demyelinating neuropathy fulfilling the criteria of European Federation of Neurological Societies.
3. Stable, ongoing treatment with SCIG
4. Written informed consent.
5. ONLS = 1 for the lower extremities and/or ONLS = 2 for the upper extremities
6. Average SSST for both legs > 8.6 s and/or average 9HPT for both hands > 23.0 s.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
1. Diagnosis of claudicatio intermittens or obvious vascular disease manifestation in the lower extremities at the discretion of the physician.
2. Clinically significant back disease or clinical sign of spinal root affection or spinal stenosis at the discretion of the physician.
3. Clinically significant systemic disease at the discretion of the physician.
4. Patient with other diseases that are expected to affect the ability to walk or the use of the arms at the discretion of the physician.
5. Patients who cannot cooperate or are unable to complete the project and patients who do not speak Danish or English.
6. Impaired kidney function (eGFR < 80 ml/min.)
7. Epilepsy or medical history of seizures.
8. Risk factors for seizures (reduced seizure threshold) either due to drug treatment (e.g. antipsychotics, antidepressants, anti-malaria drugs, tramadol, theophylline, sedating anti-histaminergic drugs) or other diseases (e.g. previous significant head trauma or diabetes with frequent episodes of significant hypoglycemia) as evaluated by an experienced neurologist.
9. Risk of important drug interactions (drugs inhibiting OCT2, e.g. cimetidine).
10. Pregnancy or lactation.
11. Women of child-bearing potential, unless they use an acceptable effective contraception measure during the study and at least 2 weeks after or their male partner, is vasectomized and their sole partner. Acceptable effective contraception is defined in the Clinical Trials Facilitation Group (CTFG) http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and include intrauterine device or hormone-releasing system or hormonal contraception or total abstinence when this reflects their usual lifestyle or female sterilization (bilateral oophorectomy or total hysterectomy at least 6 weeks before). They should also have a negative pregnancy test.
12. Known allergy to fampridine or excipients.
13. Concurrent treatment with Fampyra or other medicinal products containing fampridine (4-aminopyridine)
14. Patients inappropriate for placebo.
15. Planned surgery.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Chronic inflammatory demyelinating polyneuropathy
MedDRA version: 20.0 Level: LLT Classification code 10072650 Term: CIDP System Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Trade Name: Fampyra
Product Name: Fampyra
Pharmaceutical Form: Tablet
INN or Proposed INN: FAMPRIDINE
CAS Number: 504-24-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: The main purpose of the study is to determine the effect of treatment with the potassium-channel-inhibitor, fampridine, on clinically significant residual impairments and symptoms in patients with chronic inflammatory demyelinating polyneuropathy during stable treatment with subcutaneous immunoglobulin (SCIG).
Primary end point(s): Time to perform six-spot-step-test and nine-hole-pegboard-test.
Secondary Objective: Test if fampridine change ion channel function in CIDP
Timepoint(s) of evaluation of this end point: Baseline, two weeks, and four weeks (end of treatment).
Secondary Outcome(s)
Secondary end point(s): Patients global impression of change.
Grip strength
Composite muscle strength score (MRC)
Sensory function (INCAT sensory sum score)
Timed-10-meter-walk
Functional performance score (ONLS og R-bODS)
Nerve conduction study
Nerve threshold tracking
Timepoint(s) of evaluation of this end point: Baseline, two weeks, and four weeks (end of treatment).
Besides threshold tracking and nerve conduction study are only performed af baseline and at four weeks.
Patient global impression of change is only performed af four weeks.
Secondary ID(s)
FAM1
Source(s) of Monetary Support
Novo Nordisk Foundation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 19/08/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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