FuRST 2.0 Cognitive Pre-Testing

Huntington's Disease Clinical Trial

Official title:

FuRST 2.0: Cognitive Pre-Testing Study for a New Functional Rating Scale for Use in Huntington's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881931
• Other study ID #: C-000316
• Status: Completed
• Phase: N/A
• First received: August 12, 2016
• Last updated: August 7, 2017
• Start date: February 28, 2017
• Est. completion date: July 28, 2017

Study information

• Verified date: August 2017
• Source: CHDI Foundation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 28, 2017
• Est. primary completion date: July 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main criteria for inclusion:

1. HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)

2. At least 18 years of age

3. Must be fluent in English and had his primary education in English

4. Must be willing and able to provide written informed consent

Pre-Manifest HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 40

2. Disease Burden Score greater than or equal to 250 (calculated by the equation:

[CAGn-35.5] X age)

3. UHDRS Diagnostic Confidence Level (DCL) < 3

4. At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.

Early-Manifest (Stage 1&2) HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 36

2. DCL=4

3. UHDRS Total Functional Capacity (TFC) =7

4. Participants whose companion is willing to participate in this study and complete the scale independently

Main criteria for exclusion:

1. Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee

2. Currently participating in a clinical trial involving an investigational medicinal product

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Behavioral:
• FuRST 2.0
Cognitive Pre-testing of new Functional Rating Scale

Locations

Country	Name	City	State
Canada	CENTRE FOR MOVEMENT DISORDERS (Neuropharm Consulting)	Toronto	Ontario
United States	Rocky Mountain Movement Disorders Center, P.C.	Englewood	Colorado
United States	Columbia University	New York	New York
United States	Hereditary Neurology Disease Centre, Inc.	Wichita	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
CHDI Foundation, Inc.	Dr. Glenn T. Stebbins (Rush University Medical Center ), Nancy LaPelle, The University of Texas Health Science Center, Houston

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants' comprehension of the FuRST 2.0 rating scale measured by qualitative analysis	The primary assessment will use qualitative analysis of the cognitive interview to determine the usability of the FuRST 2.0 scale in the HD population.	8 months
Secondary	The difference between the ratings of the HDGEC participants and the companions measured by the FuRST 2.0 rating scale	The secondary outcome measure will be evaluated using the Kolmogorov-Smirnov test	8 months