A study of T06 in patients with amyotrophic lateral sclerosis and Parkinson’s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13974483

Enrollment

Registered

2023-01-27

Start date

2019-01-05

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis and Parkinson’s disease Nervous System Diseases

Interventions

T06 is a protein being studied as a potential treatment for amyotrophic lateral sclerosis (ALS) and Parkinson’s disease (PD). Currently, there are only a few FDA-approved drugs to treat ALS or PD, but

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients =18 years of age with sporadic or familial ALS or PD 2. If taking riluzole and/or edaravone, must be on a stable dose prior to screening

Exclusion criteria

Exclusion criteria: 1. History of a clinically significant non-ALS or PD neurologic disorder 2. Inability to swallow capsules. 3. Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus 4. Women who are pregnant, planning to become pregnant, or are breastfeeding. 5. Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or any form of oxygen supplementation. 6. Current or anticipated need for a diaphragm pacing system (DPS). 7. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months. 8. Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 09/11/2023: Motor function measured using the ALS Functional Rating Scale-Revised (ALS-FRS-R) scale at baseline and 2, 6, 10, 22 and 46 weeks or the statement of patients were evaluated by Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) at baseline and 2, 6, 10, 22 and 46 weeks Previous primary outcome measure: Motor function measured using the ALS Functional Rating Scale-Revised (ALS-FRS-R) scale at baseline and 2, 6, 10, 22 and 46 weeks	—

Measure

Time frame

Current primary outcome measure as of 09/11/2023: Motor function measured using the ALS Functional Rating Scale-Revised (ALS-FRS-R) scale at baseline and 2, 6, 10, 22 and 46 weeks or the statement of patients were evaluated by Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) at baseline and 2, 6, 10, 22 and 46 weeks Previous primary outcome measure: Motor function measured using the ALS Functional Rating Scale-Revised (ALS-FRS-R) scale at baseline and 2, 6, 10, 22 and 46 weeks

—

Secondary

Measure	Time frame
Adverse events measured by a routine blood tests, blood biochemistry, coagulation function, hemolysis function, routine urine tests, 12 lead ECG, physical examination, vital signs, etc at baseline and 22 and 46 weeks	—

Countries

China

Contacts

Public ContactChunying Guo

guocy@talengen-pharma.com+86 15919440001

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026