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Trial record 1 of 350 for:    CMT
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Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03966287
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Michael W Sereda, MD, Professor of Neurology, University Medical Center Goettingen

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 29, 2019
Last Update Posted Date September 27, 2019
Actual Study Start Date June 3, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019)
  • SF-36 Questionnaire [ Time Frame: 1 year ]
    Questionnaire to evaluate health status
  • NPSI-G Questionnaire [ Time Frame: 1 day ]
    Questionnaire to discriminate neuropathic and non-neuropathic pain
  • PAIN DETECT Questionnaire [ Time Frame: 4 weeks ]
    Questionnaire for the diagnosis of neuropathic pain (intensity, pattern, quality)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03966287 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)
Official Title Analysis of Pain and Quality of Life in Patients With Charcot-Marie-Tooth Neuropathy (CMT)
Brief Summary The study aims to qualitatively and quantitively evaluate pain in patients suffering from CMT with 3 standardized questionnaires (SF-36, NPSI-G, PAIN DETECT) as well as its impact on the quality of life.
Detailed Description

Hereditary neuropathies are a group of clinically and genetically heterogeneous diseases of the peripheral nervous system. Charcot-Marie-Tooth disease (CMT), also known as hereditary motor and sensory neuropathy (HMSN), is the most common form of hereditary neuropathy with a prevalence of approximately 1 in 2,500 and with approximately 30,000 affected persons in Germany. There is no therapy known so far. In addition to the characteristic symptoms of a distal to proximal progressive symmetric muscular atrophy, especially of the lower extremities, there is a weakening of the muscles of the lower legs and feet, with emphasis on the "small" foot muscles and the peroneal muscle group, which clinically manifests as a so-called "stepper gait". It is also known that many CMT patients additionally suffer from pain, but more detailed studies on pain quality and quantity and their impact on patients' quality of life have not yet been systematically performed. These parameters will be investigated in this study, supported by the company Grünenthal, in the form of a questionnaire survey with validated questionnaires on pain and quality of life for at least 200 CMT patients. A representative result could lead to further investigations of pain in CMT patients and ultimately to the development of an adequate pain therapy.

Recruitment of patients will occur mainly through a call of the Germany-wide CMT registry, which is part of the national research network CMT-NET (coordinator: Prof. Michael Sereda). Interested patients are invited to contact the study team at the UMG. The patients will be informed about the study and if further interested 4 questionnaires (1 regarding the personal history as well as 3 standardized questionnaires from literature regarding quality of life and pain (SF-36, NPSI-G, PAIN DETECT) will be sent to the patients together with obligatory study documents and a pre-franked return envelope. A personal visit at the UMG is not planned, so that the patients don´t have any expenses. The data are pseudonymized at the UMG and transferred to a database and finally statistically evaluated by Gruenenthal.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population German-wide, registered patients in CMT-registry
Condition CMT
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 27, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of CMT
  • Genetic confirmation of CMT diagnosis
  • Age between 18 and 65 years
  • Signed consent form

Exclusion Criteria:

  • Other relevant neurological or psychiatric diseases, acute or past
  • Serious internal medical illness
  • Drug and / or alcohol dependence
  • Participation in another clinical trial within 4 weeks prior to enrollment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lisa Reinecke, Dr. +49 551 39 ext 9662 knp.cmt-register@med.uni-goettingen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03966287
Other Study ID Numbers 02202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Michael W Sereda, MD, Professor of Neurology, University Medical Center Goettingen
Study Sponsor University Medical Center Goettingen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Medical Center Goettingen
Verification Date September 2019