Cistanche Total Glycosides for Amyotrophic Lateral Sclerosis: A Randomized Control Trial (RCT) Study Assessing Clinical Response

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT00753571
First received: September 15, 2008
Last updated: December 29, 2009
Last verified: September 2008
  Purpose

This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset, progressive motor neurons loss in the spinal cord, brain stem and motor cortex. Patients develop progressive wasting and weakness of both upper and lower limbs, bulbar and respiratory muscles. Usually death from respiratory failure typically is within 3-5 years of diagnosis. Although there are various treatments for ALS, riluzole is the only approved treatment to delay the disease progression. Cistanche Total Glycosides is an approved drug that has protective effects. It acts anti-apoptosis by activating several protective pathways, stimulates neuronal differentiation of adult neural stem cells in the brain, and improves long-term recovery. CTG is a highly attractive candidate for the treatment of neurodegenerative conditions such as ALS.

Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years of duration may be eligible for this study. Candidates will be screened with a medical history and possible review of medical records, physical examination, blood test, urine and stool analyses, electrocardiogram, electrophysiological examination, neurological imaging and, for women, a pregnancy test.

Participants will have drug therapy according to randomized number. One group receives CTG while other group receives placebo. For the procedure, patients are given a medication to lessen anxiety and any discomfort. Patients receive drugs for 9 months. The CTG dosage is 1.8g/day. Physical examination and interview, Appel ALS scale and ALS-Functional Rating Scale will be done in 28 days and 3, 6, 9months. Electrophysiological examination will be tested per 3 months. Blood samples will be collected on treat28 days and 3, 6, 9months.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Cistanche Total Glycosides
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cistanche Total Glycosides Treatment for Amyotrophic Lateral Sclerosis: A Randomized Control Trial Study Assessing Clinical Response

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • The mean rate of decline of ALS-FRS score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The mean rate decline of the AARS score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
1,CTG,po
Drug: Cistanche Total Glycosides

Drug: Cistanche Total Glycosides Cistanche Total Glycosides ,1.8g/day(6 capsules) po Qd*9months Arms: 1 Drug: blank capsules 6 capsules po Qd*9months

Arms: 2

Placebo Comparator: 2 Drug: Cistanche Total Glycosides

Drug: Cistanche Total Glycosides Cistanche Total Glycosides ,1.8g/day(6 capsules) po Qd*9months Arms: 1 Drug: blank capsules 6 capsules po Qd*9months

Arms: 2


Detailed Description:

This study will examine the effectiveness of Cistanche Total Glycosides(CTG) in treating patients with amyotrophic lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset, progressive motor neurons loss in the spinal cord, brain stem and motor cortex. Patients develop progressive wasting and weakness of both upper and lower limbs, bulbar and respiratory muscles. Usually death from respiratory failure typically is within 3-5 years of diagnosis. Although there are various treatments for ALS, riluzole is the only approved treatment to delay the disease progression. Cistanche Total Glycosides is an approved drug that has protective effects. It acts anti-apoptosis by activating several protective pathways, stimulates neuronal differentiation of adult neural stem cells in the brain, and improves long-term recovery. CTG is a highly attractive candidate for the treatment of neurodegenerative conditions such as ALS.

Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years of duration may be eligible for this study. Candidates will be screened with a medical history and possible review of medical records, physical examination, blood test, urine and stool analyses, electrocardiogram, electrophysiological examination, neurological imaging and, for women, a pregnancy test.

Participants will have drug therapy according to randomized number. One group receives CTG while other group receives placebo. For the procedure, patients are given a medication to lessen anxiety and any discomfort. Patients receive drugs for 9 months. The CTG dosage is 1.8g/day. Physical examination and interview, Appel ALS scale and ALS-Functional Rating Scale will be done in 28 days and 3, 6, 9months. Electrophysiological examination will be tested per 3 months. Blood samples will be collected on treat28 days and 3, 6, 9months.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects must have a verifiable diagnosis of ALS of 0.5 to 2 years' duration.
  • The diagnosis must be supported by the Revised Criteria of the World Federation of Neurology.
  • The grades of diagnosis must be clinically definite ALS or clinically probable ALS.
  • All subjects must be over age 18 and below 65.
  • The ALS is mildly to moderate based on ALS Health State Scale.
  • Electrophysiological features show CMAP amplitude of motor nerve normal or mild declining.
  • Serum creatine kinase is normal or mild upper, less than 500U/L.

Exclusion Criteria:

  • If anyone of the above eligibility requirements is not met
  • Use of any other investigational agent within 30 days beginning the treatment phase of this study
  • Severe cardiac, pulmonary, hepatic or/and hematic disease
  • HIV positivity or signs and symptoms consistent with HIV infection
  • Pregnant or nursing women
  • History of cancer with less than 5 years documentation of a disease-free state
  • History of anaphylactic reaction or hypersensitivity to G-CSF or proteins derived from E.coli
  • Alcohol or drug abuse in recent 1 year
  • Can't understand or obey the rules of treatment
  • Blood donor in recent 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753571

Contacts
Contact: Dongsheng Fan MD Fan, Docter +861082265250 ext 0 dsfan@sina.com ; chinaals@gmail.com
Contact: Wang Liping Wang +861082265024 chinaals@gmail.com

Locations
China, Beijing
Dongsheng Fan, MD; Liping Wang,MD Recruiting
Beijing, Beijing, China, 100191
Contact: Dongsheng Fan MD Fan, Docter    +861082265250 ext 0    chinaals@gmail.com;dsfan@sina.com ;   
Contact: Liping Wang MD Wang, doctor    +8613810002694    chinaals@gmail.com;dianer@126.com   
Sponsors and Collaborators
Peking University
  More Information

Additional Information:
No publications provided

Responsible Party: Dongsheng Fan, MD, Peiking University Third Hospital
ClinicalTrials.gov Identifier: NCT00753571     History of Changes
Other Study ID Numbers: PUTH-1
Study First Received: September 15, 2008
Last Updated: December 29, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Amyotrophic Lateral Sclerosis
Cistanche Total Glycosides
Randomized Control Trial Study

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Cardiac Glycosides
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014