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A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis

A Multi-center, Randomized, Double Blinding, Placebo-Controlled Clinical Trial of Dl-3-Butylphthalide in the Treatment of Amyotrophic Lateral Sclerosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007365
Enrollment
Unknown
Registered
2015-11-03
Start date
2015-11-04
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

amyotrophic lateral sclerosis

Interventions

Control group:to give placebo, 2 / time, 3 times / day, fasting

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) The patient or the patients legal representative have provided singed written informed consent; (2) Diagnosis of "probable" or "definite" amyotrophic lateral sclerosis according to the revised El Escorial revised criteria; (3) Ages 20 to 75 years inclusive; (4) First ALS symptoms occurred <=3 monthss prior to screening; (5) Not taking riluzole for at least 3 month prior to the screening visit.

Exclusion criteria

Exclusion criteria: (1) Patients whose EMG examination reveals motor nerve conduction block or sensory nerve conduction abnormalities; (2) Patients in whom causes of neuromuscular weakness other than ALS; (3) Patients who are diagnosed as having dementia or mental disorders; (4) Patients who have serious diseases including cardiovascular, liver, kidney or other serious disease; (5) Onset of the weakness of respiratory muscle.

Design outcomes

Primary

MeasureTime frame
ALSFRS-R;

Secondary

MeasureTime frame
survival rate;MUNE;Muscle strength;Pulmonary function testing;Clinical overall impression score;

Countries

China

Contacts

Public ContactCui Liying
pumchcly@yahoo.com.cn+86 010 65296373

Outcome results

None listed

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