NCT03603171 (COMEDY-2) is a clinical trial of DM1-ActivC in Myotonic Dystrophy Type 2, sponsored by Prof. Dr. Benedikt Schoser.

Who is sponsoring NCT03603171?

NCT03603171 is sponsored by Prof. Dr. Benedikt Schoser.

What drugs are being tested in NCT03603171?

Interventions in NCT03603171: DM1-ActivC, R-PAct, Beck depression inventory, McGill pain questionnaire, Brief Pain Inventory Short-Form, Fatigue and Daytime Sleepiness Scale, Myotonia Behaviour scale, Hand opening time, Pressure pain threshold, Manual muscle testing, Quantitative muscle testing, Scale for Assessment and Rating of Ataxia, Berg balance scale, Quick motor function test, GSGC, 30 seconds sit to stand test, Functional Index-2, Six minute walking test, Myotonia (from Individualised Neuromuscular Quality of Life Questionnaire).

What condition does NCT03603171 study?

NCT03603171 studies Myotonic Dystrophy Type 2.

Is NCT03603171 still recruiting?

NCT03603171 is currently completed. Last updated 20 February 2020.

Last reviewed 2020-02-20 · How we verify

NCT03603171: COMEDY-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Outcome Measures in Myotonic Dystrophy Type 2

Completed Last updated 20 February 2020

What this trial tests

trial testing DM1-ActivC in Myotonic Dystrophy Type 2 in 60 participants. Completed in 1 February 2020.

Timeline

1 July 2018

Primary endpoint
31 December 2019

1 February 2020

Quick facts

Lead sponsor	Prof. Dr. Benedikt Schoser
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	1 July 2018
Primary completion	31 December 2019
Estimated completion	1 February 2020
Sites	1 location across Germany

Drugs / interventions tested

DM1-ActivC
R-PAct
Beck depression inventory
McGill pain questionnaire
Brief Pain Inventory Short-Form
Fatigue and Daytime Sleepiness Scale
Myotonia Behaviour scale
Hand opening time
Pressure pain threshold
Manual muscle testing
Quantitative muscle testing
Scale for Assessment and Rating of Ataxia
Berg balance scale
Quick motor function test
GSGC
30 seconds sit to stand test
Functional Index-2
Six minute walking test
Myotonia (from Individualised Neuromuscular Quality of Life Questionnaire)

Conditions studied

Myotonic Dystrophy Type 2 — all drugs for Myotonic Dystrophy Type 2 →

Sponsor

Prof. Dr. Benedikt Schoser

Who can join

Adults 18 to 90, any sex, with Myotonic Dystrophy Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A monocentric, longitudinal, observational case-control study in patients with Myotonic Dystrophy type 2 (DM2). At least 60 DM2 will be evaluated through a battery of patients reported Outcomes (PROs) and clinical Outcome Measures (OMs), in order to define suitable OMs for DM2 and propose a disease specific severity scale. Patients will be re-evaluated after 6 months. An age and gender-matched control cohort will be assessed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Validation of Motor Outcome Measures in Myotonic Dystrophy Type 2.
Montagnese F, Rastelli E, Khizanishvili N, Massa R, et al · · 2020 · cited 6× · PMID 32373059 · DOI 10.3389/fneur.2020.00306

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03603171 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Prof. Dr. Benedikt Schoser
Last refreshed: 20 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03603171.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing