NCT03966287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 3, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

May 21, 2019

Last Update Submit

November 4, 2020

Conditions

CMT

Outcome Measures

Primary Outcomes (3)

  • SF-36 Questionnaire

    Questionnaire to evaluate health status

    1 year

  • NPSI-G Questionnaire

    Questionnaire to discriminate neuropathic and non-neuropathic pain

    1 day

  • PAIN DETECT Questionnaire

    Questionnaire for the diagnosis of neuropathic pain (intensity, pattern, quality)

    4 weeks

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

German-wide, registered patients in CMT-registry

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre

Goettigen, 37075, Germany

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Michael W. Sereda

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 29, 2019

Study Start

June 3, 2019

Primary Completion

January 31, 2020

Study Completion

March 31, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

DE(1)