Trial · NCT02858908

Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy

NCT02858908, Phase 2, Completed, AMO Pharma Limited; results first posted 2025-09-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy. Trials, record NCT02858908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02858908

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Tideglusib in Adolescent and Adult Patients With Myotonic Dystrophy
NCT number: NCT02858908
Status: Completed
Phases: Phase 2
Enrollment: 16 participants, actual
Lead sponsor: AMO Pharma Limited
Conditions: Myotonic Dystrophy 1
Interventions: Tideglusib
First posted: 2016-08-08
Last updated: 2025-09-11
Other registries' IDs: eudract:2016-000067-16
Results first posted: 2025-09-11

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety (Adverse Events)	12 weeks	Incidence of Adverse events (AEs), including serious adverse events (SAEs), between baseline to end of study.
Secondary	Plasma Concentration of Tideglusib	12 weeks	Pharmacokinetic samples were collected to determine Tideglusib plasma concentration
Secondary	Blood Pharmacokinetics of Tideglusib	12 weeks	Pharmacokinetic samples were collected to determine time of the maximum plasma concentration and terminal elimination half-life of tideglusib
Secondary	Area Under the Plasma Concentration vs. Time Curve of Tideglusib	12 weeks	Pharmacokinetic samples were collected to determine area under the plasma concentration vs. time curve from 0 to 12 h and area under the plasma concentration vs. time curve from 0 to 24 h of tideglusib
Secondary	10 Metre Walk/Run Test	12 weeks	The 10-metre walk/run test is a performance measure used to assess walking speed in metres per second over a short distance and was used as an assessment of functional mobility. Time taken to complete the 10m walk/run test at fastest and preferred speed is measured.
Secondary	Computerised Handgrip Myometer Measure of Grip Strength and Muscle Relaxation Time	12 weeks	Handgrip myometry is used as a measure of myotonia and muscle strength for the dominant hand
Secondary	Respiratory Forced Vital Capacity (FVC)	12 weeks	FVC is a measure of lung function (the total amount of air exhaled during a Forced Expiratory Volume is measured using a spirometer)
Secondary	Dual-energy X-ray Absorptiometry (DXA)	12 weeks	DXA utilises two low energy X-ray beams, with different energy levels, which are aimed at the subject's bones. The DXA scan is more typically used to measure bone mineral density, however it can also be used to measure total lean muscle mass
Secondary	Clinical Global Impressions- Severity (CGI-S)	12 weeks	The CGI-S is a 7-point Likert type scale that requires the clinician to rate the severity of the subject's illness at the time of assessment, relative to the clinician's past experience with subjects who have the same diagnosis. Considering total clinical experience, a subject is assessed on severity of illness at the time of rating 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. Change in CGI-S was observed in only 1 subject. Consequently statistical analysis was not conducted.
Secondary	Clinical Global Impressions- Improvement (CGI-I)	12 weeks	The CGI-I requires the clinician to rate how much the subject's illness has improved or worsened relative to a baseline state. A seven point Likert type scale is used from 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety (Adverse Events)	12 weeks	Safety Analysis Set	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Plasma Concentration of Tideglusib	12 weeks	Full Analysis Set	ng/mL	MEAN
SECONDARY	Blood Pharmacokinetics of Tideglusib	12 weeks	Full Analysis Set	h	MEAN
SECONDARY	Area Under the Plasma Concentration vs. Time Curve of Tideglusib	12 weeks	Full Analysis Set	ng/mL.h	MEAN
SECONDARY	10 Metre Walk/Run Test	12 weeks	Full Analysis Set	seconds	MEAN
SECONDARY	Computerised Handgrip Myometer Measure of Grip Strength and Muscle Relaxation Time	12 weeks	Full Analysis Set	kg	MEAN
SECONDARY	Respiratory Forced Vital Capacity (FVC)	12 weeks	Full Analysis Set	litres	MEAN
SECONDARY	Dual-energy X-ray Absorptiometry (DXA)	12 weeks	Full Analysis Set	gram	MEAN
SECONDARY	Clinical Global Impressions- Severity (CGI-S)	12 weeks	Full Analysis Set	Values on a scale	MEAN
SECONDARY	Clinical Global Impressions- Improvement (CGI-I)	12 weeks	Full Analysis Set	Scores on a scale	MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group112

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Safety (Adverse Events)	Cohort 1	Total number of TEAEs	8	Participants
Safety (Adverse Events)	Cohort 2	Total number of TEAEs	6	Participants
Safety (Adverse Events)	Cohort 1	Total number of serious TEAEs	0	Participants
Safety (Adverse Events)	Cohort 2	Total number of serious TEAEs	0	Participants
Safety (Adverse Events)	Cohort 1	Total number of TEAEs leading to discontinuation of active treatment	0	Participants
Safety (Adverse Events)	Cohort 2	Total number of TEAEs leading to discontinuation of active treatment	0	Participants
Safety (Adverse Events)	Cohort 1	Total number of TEAEs leading to withdrawal	0	Participants
Safety (Adverse Events)	Cohort 2	Total number of TEAEs leading to withdrawal	0	Participants
Safety (Adverse Events)	Cohort 1	Total number of TEAEs leading to death	0	Participants
Safety (Adverse Events)	Cohort 2	Total number of TEAEs leading to death	0	Participants

1 to 10 of 112Source ClinicalTrials.gov

See all 112 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cohort 1	8
Overall Study	STARTED	Cohort 2	8
Overall Study	COMPLETED	Cohort 1	8
Overall Study	COMPLETED	Cohort 2	8
Overall Study	NOT COMPLETED	Cohort 1	0
Overall Study	NOT COMPLETED	Cohort 2	0

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Back injury	Injury, poisoning and procedural complications	Cohort 1	1	8	1
other	Back injury	Injury, poisoning and procedural complications	Cohort 2	0	8	0
other	Fall	Injury, poisoning and procedural complications	Cohort 1	1	8	1
other	Fall	Injury, poisoning and procedural complications	Cohort 2	0	8	0
other	Joint dislocation	Injury, poisoning and procedural complications	Cohort 1	1	8	1
other	Joint dislocation	Injury, poisoning and procedural complications	Cohort 2	0	8	0
other	Laceration	Injury, poisoning and procedural complications	Cohort 1	1	8	1
other	Laceration	Injury, poisoning and procedural complications	Cohort 2	0	8	0
other	Limb injury	Injury, poisoning and procedural complications	Cohort 1	0	8	0
other	Limb injury	Injury, poisoning and procedural complications	Cohort 2	1	8	2

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cohort 1	0	8
Total, all-cause mortality	Cohort 2	0	8
Total, other adverse events	Cohort 1	8	8
Total, other adverse events	Cohort 2	6	8
Total, serious adverse events	Cohort 1	0	8
Total, serious adverse events	Cohort 2	0	8

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32942085	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Cohort 1 vs Cohort 2: deaths from any cause	Trial comparisons
Cohort 1 vs Cohort 2: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Vocabulary Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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